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Patient Weight(kg):
Reporter Country: US
Individual Submitting: Consumer or non-health professional
Expedited?: Not expedited

Patient Reaction: Maternal exposure during pregnancy,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
ISENTRESS 800 MG, QD Oral Dose not changed Suspect drug HIV INFECTION
TRUVADA 1 TAB/CAPS, QD Oral Dose not changed Suspect drug HIV INFECTION
PREZISTA 2 TAB/CAPS, QD Oral Dose not changed Suspect drug HIV INFECTION 2013-10-22
NORVIR 200 MG, QD Oral Dose not changed Suspect drug HIV INFECTION 2013-10-22

Drug Info:

Generic Name: RALTEGRAVIR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE DARUNAVIR RITONAVIR
Pharmacologic Class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Application Number: NDA022145 NDA203045 NDA205786 NDA021752 NDA021976 NDA202895 NDA020659 NDA022417 NDA209512

SPL ID: 9434823c-41b1-4536-91eb-45bb4094fdf8, b4b9ab85-a958-450c-8c65-38411a1f7d8b, f4fed136-638c-11ea-959a-33fefb2ca371, 3ed2a506-7b2a-8787-d093-941b0f35bcf4,
SPL Set ID: 89a5ec53-d956-4329-8004-0f40f51c88a3, 54e82b13-a037-49ed-b4b3-030b37c0ecdd, 814301f9-c990-46a5-b481-2879a521a16f, 2849298e-de6e-47bb-8194-56e075b33fc3,

Patient Weight(kg):
Reporter Country: GB
Individual Submitting: Other health professional
Expedited?: Expedited

Patient Reaction: Lower respiratory tract infection, Pneumonia,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
OMEPRAZOLE. UNK Concomitant drug GASTROOESOPHAGEAL REFLUX DISEASE 200802
PARACETAMOL 1 G, 4X/DAY Concomitant drug 201009
SULFASALAZINE. 1000 MG, 2X/DAY Oral Concomitant drug 200612 201003
OMEPRAZOLE. UNK Concomitant drug HIATUS HERNIA
CALCICHEW-D3 FORTE UNK Concomitant drug 201209
ALENDRONIC ACID UNK Concomitant drug 201209
CODEINE 60 MG, 3X/DAY Oral Concomitant drug 201001
ETANERCEPT 50 MG, QWK Unknown Drug withdrawn Suspect drug 2014-02-25
HYDROXYCHLOROQUINE 200 MG, 1X/DAY Oral Concomitant drug 2003 200611
FOLIC ACID. UNK Concomitant drug 200911
LEFLUNOMIDE. 20 MG, 1X/DAY Oral Concomitant drug 201001 201308
RAMIPRIL. UNK Concomitant drug HYPERTENSION 201006
NAPROXEN. UNK Concomitant drug 201304 201306
METHOTREXATE 20 MG, WEEKLY Subcutaneous Concomitant drug 200911
ETANERCEPT 50 MG, QWK Unknown Drug withdrawn Suspect drug RHEUMATOID ARTHRITIS 2013-10-28 2014-01-13
PRAVASTATIN UNK Concomitant drug BLOOD CHOLESTEROL INCREASED 201304
AMLODIPINE UNK Concomitant drug HYPERTENSION 200103

Drug Info:

Generic Name: OMEPRAZOLE OMEPRAZOLE MAGNESIUM SULFASALAZINE OMEPRAZOLE OMEPRAZOLE MAGNESIUM ETANERCEPT FOLIC ACID LEFLUNOMIDE RAMIPRIL NAPROXEN NAPROXEN SODIUM NAPROXEN SODIUM 220 MG METHOTREXATE METHOTREXATE SODIUM ETANERCEPT AMLODIPINE
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: NDA022032 ANDA210593 ANDA207891 ANDA075410 ANDA075757 ANDA206877 NDA209400 ANDA091352 ANDA078878 ANDA206582 ANDA207740 ANDA076515 ANDA076048 ANDA204012 ANDA211732 ANDA091672 ANDA078490 ANDA075576 ANDA203270 ANDA203481 NDA007073 ANDA085828 NDA022032 ANDA210593 ANDA207891 ANDA075410 ANDA075757 ANDA206877 NDA209400 ANDA091352 ANDA078878 ANDA206582 ANDA207740 ANDA076515 ANDA076048 ANDA204012 ANDA211732 ANDA091672 ANDA078490 ANDA075576 ANDA203270 ANDA203481 BLA103795 ANDA040796 ANDA204418 ANDA202437 ANDA091145 ANDA202522 ANDA040756 ANDA040625 ANDA089202 ANDA090035 ANDA091369 ANDA211863 ANDA077086 ANDA212308 ANDA212453 NDA020905 ANDA077090 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191 ANDA091416 NDA018965 ANDA204872 ANDA090545 ANDA091432 ANDA075927 ANDA091305 ANDA212705 ANDA091353 ANDA212517 ANDA078620 ANDA079096 ANDA074190 ANDA078250 NDA020067 NDA017581 ANDA075227 ANDA200429 NDA011719 ANDA040385 ANDA040263 ANDA040632 ANDA201529 ANDA201530 NDA008085 ANDA201749 ANDA081235 ANDA040843 NDA205776 ANDA210454 NDA208400 ANDA040266 NDA210737 ANDA207812 ANDA081099 ANDA040716 ANDA210040 ANDA089343 ANDA089342 ANDA089341 ANDA089340 ANDA213343 NDA204824 BLA103795 NDA211340 ANDA201380
Manufacturer Name:
(Google Search)
Amerisource Bergen Costco Wholesale Company INNOVUS PHARMACEUTICALS, INC. OHM LABORATORIES INC. Lannett Company, Inc. Sandoz Inc Cardinal Health BJWC CVS Pharmacy, Inc. DISCOUNT DRUG MART L. Perrigo Company Aurohealth LLC Sam's West Inc Meijer Distribution Inc CVS Pharmacy H E B Fred's, Inc. Wal-Mart Stores Inc THE KROGER COMPANY Dolgencorp, LLC Ohm Laboratories Inc. Topco Associates LLC Lidl US LLC Cadila Healthcare Limited Chain Drug Consortium, LLC Rite Aid Corporation Walgreen Company Genomma Lab USA, Inc. Family Dollar Services Inc Supervalu Inc P & L Development, LLC American Sales Company Reliable 1 Laboratories LLC Perrigo New York Inc BluePoint Laboratories Harris Teeter, LLC Shopko Stores Operating Co., LLC Sun Pharmaceutical Industries, Inc. Big Lots Stores, Inc. Zydus Pharmaceuticals (USA) Inc. Gericare Pharmaceuticals Apotex Corp Rite Aid Harmon Stores Inc. Rugby Laboratories Major Pharmaceuticals Camber Pharmaceuticals, Inc. Safeway Camber Consumer Care Glenmark Pharmaceuticals Inc., USA Publix Super Markets Inc Save-A-Lot Food Stores Ltd Dr. Reddy's Laboratories Limited Thirty Madison Inc Strategic Sourcing Services LLC Aldi Inc NorthStar Rx LLC Target Corporation Kroger Company Family Dollar, Inc. Breckenridge Pharmaceutical, Inc. Humana Pharmacy, Inc. Bi-Mart Dr. Reddys Laboratories Inc Amazon.com Services LLC Aurobindo Pharma Limited Winco Foods, LLC. 7-Eleven Army & Air Force Exchange Service Best Choice Rising Health, LLC Wal-Mart Stores, Inc. GERICARE PHARMACEUTICALS Pharmacia and Upjohn Company LLC Actavis Pharma, Inc. Greenstone LLC Amerisource Bergen Costco Wholesale Company INNOVUS PHARMACEUTICALS, INC. OHM LABORATORIES INC. Lannett Company, Inc. Sandoz Inc Cardinal Health BJWC CVS Pharmacy, Inc. DISCOUNT DRUG MART L. Perrigo Company Aurohealth LLC Sam's West Inc Meijer Distribution Inc CVS Pharmacy H E B Fred's, Inc. Wal-Mart Stores Inc THE KROGER COMPANY Dolgencorp, LLC Ohm Laboratories Inc. Topco Associates LLC Lidl US LLC Cadila Healthcare Limited Chain Drug Consortium, LLC Rite Aid Corporation Walgreen Company Genomma Lab USA, Inc. Family Dollar Services Inc Supervalu Inc P & L Development, LLC American Sales Company Reliable 1 Laboratories LLC Perrigo New York Inc BluePoint Laboratories Harris Teeter, LLC Shopko Stores Operating Co., LLC Sun Pharmaceutical Industries, Inc. Big Lots Stores, Inc. Zydus Pharmaceuticals (USA) Inc. Gericare Pharmaceuticals Apotex Corp Rite Aid Harmon Stores Inc. Rugby Laboratories Major Pharmaceuticals Camber Pharmaceuticals, Inc. Safeway Camber Consumer Care Glenmark Pharmaceuticals Inc., USA Publix Super Markets Inc Save-A-Lot Food Stores Ltd Dr. Reddy's Laboratories Limited Thirty Madison Inc Strategic Sourcing Services LLC Aldi Inc NorthStar Rx LLC Target Corporation Kroger Company Family Dollar, Inc. Breckenridge Pharmaceutical, Inc. Humana Pharmacy, Inc. Bi-Mart Dr. Reddys Laboratories Inc Amazon.com Services LLC Aurobindo Pharma Limited Winco Foods, LLC. 7-Eleven Army & Air Force Exchange Service Best Choice Rising Health, LLC Wal-Mart Stores, Inc. GERICARE PHARMACEUTICALS Immunex Corporation Leading Pharma, LLC Marlex Pharmaceuticals Inc Cadila Pharmaceuticals Limited Method Pharmaceuticals, LLC SUNRISE PHARMACEUTICAL, INC. X-GEN Pharmaceuticals, Inc. AiPing Pharmaceutical, Inc. Par Pharmaceutical Amneal Pharmaceuticals LLC PureTek Corporation Fresenius Kabi USA, LLC Chartwell RX LLC Alembic Pharmaceuticals Limited Lupin Pharmaceuticals, Inc. Heritage Pharmaceuticals Inc. Alembic Pharmaceuticals Inc. Cadila Healthcare Limited Zydus Pharmaceuticals (USA) Inc. KVK-Tech, Inc. Winthrop U.S. Apotex Corp. sanofi-aventis U.S. LLC Lupin Pharmaceuticals, Inc. Cadila Healthcare Limited Pfizer Laboratories Div Pfizer Inc Zydus Pharmaceuticals (USA) Inc. West-Ward Pharmaceuticals Corp. Rising Health, LLC Exelan Pharmaceuticals, Inc. Accord Healthcare Inc. Aurobindo Pharma Limited BluePoint Laboratories Chartwell RX, LLC. Dr. Reddy's Laboratories Limited MARKSANS PHARMA LIMITED Allegis Holdings, LLC Amerisource Bergen Allegiant Health Virtus Pharmaceuticals, LLC Amneal Pharmaceuticals of New York LLC Athena Bioscience Exelan Pharmaceuticals, Inc. Cipla USA Inc. Amneal Pharmaceuticals NY LLC Safetec of America, Inc. WALGREENS ScieGen Pharmaceuticals, Inc. Cadila Healthcare Limited L.N.K. International, Inc. Palmetto Pharmaceuticals Glenmark Pharmaceuticals Limited Inc., USA Amneal Pharmaceuticals LLC TIME CAP LABORATORIES Woodward Pharma Services LLC Canton Laboratories Geri-Care Pharmaceutical Corp Teva Pharmaceuticals USA, Inc. Zydus Pharmaceuticals (USA) Inc. Aurobindo Pharma Limited Hospira, Inc. Teva Women's Health, Inc. Fresenius Kabi USA, LLC Hikma Pharmaceuticals USA Inc. Mylan Institutional LLC Par Pharmaceutical, Inc. Sun Pharmaceutical Industries, Inc. Mylan Pharmaceuticals Inc. Teva Parenteral Medicines, Inc. Medexus Pharma Inc. Aurobindo Pharma Limited Azurity Pharmaceuticals, Inc. Cumberland Pharmaceuticals Inc. Zydus Pharmaceuticals (USA) Inc. Teva Pharmaceuticals USA, Inc. Accord Healthcare, Inc. Amneal Pharmaceuticals NY LLC Cadila Healthcare Limited Antares Pharma, Inc. Immunex Corporation Azurity Pharmaceuticals, Inc. Macleods Pharmaceuticals Limited

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50228-436-05, 50228-436-10, 65841-676-01, 65841-676-10, 65841-677-01, 65841-677-05, 65841-677-10, 65841-678-01, 65841-678-05, 65841-678-10, 50844-271-43, 68134-201-16, 50844-261-08, 68462-188-01, 68462-188-05, 68462-189-01, 68462-189-05, 68462-190-30, 68462-190-50, 68462-190-01, 68462-190-05, 68462-178-01, 68462-178-05, 68462-179-01, 68462-179-05, 65162-188-10, 65162-188-50, 65162-188-11, 65162-189-10, 65162-189-50, 65162-189-11, 65162-190-10, 65162-190-50, 65162-190-11, 49483-617-01, 49483-617-50, 49483-618-01, 49483-618-50, 49483-619-01, 49483-619-50, 69784-505-01, 69784-501-01, 69784-500-01, 69784-550-01, 69437-316-01, 69437-415-01, 69437-416-01, 69437-203-01, 57896-954-01, 57896-954-05, 57896-954-50, 0093-1005-01, 0093-1005-05, 0093-1006-01, 0093-1006-05, 68382-012-01, 68382-012-10, 68382-013-01, 68382-013-05, 68382-013-10, 68382-014-01, 68382-014-05, 68382-014-10, 65862-520-01, 65862-520-05, 65862-520-99, 65862-520-10, 65862-521-01, 65862-521-05, 65862-521-99, 65862-522-01, 65862-522-05, 65862-522-26, 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367-01, 51285-368-01, 51285-369-01, 63323-123-10, 0143-9830-01, 67457-467-21, 67457-467-99, 67457-486-04, 67457-486-99, 67457-485-08, 67457-485-99, 67457-466-10, 67457-480-40, 67253-320-10, 67253-320-36, 47335-235-96, 47335-235-83, 0378-0014-01, 0703-3678-81, 0143-9367-01, 59137-505-00, 59137-505-01, 59137-505-04, 59137-510-00, 59137-510-01, 59137-510-04, 59137-515-00, 59137-515-01, 59137-515-04, 59137-520-00, 59137-520-01, 59137-520-04, 59137-525-00, 59137-525-01, 59137-525-04, 59137-530-00, 59137-530-01, 59137-530-04, 59137-535-00, 59137-535-01, 59137-535-04, 59137-540-00, 59137-540-01, 59137-540-04, 59137-550-00, 59137-550-01, 59137-550-04, 59651-182-36, 59651-182-01, 52652-2001-1, 52652-2001-6, 63323-122-50, 0703-3671-01, 0703-3675-01, 0703-3678-01, 66220-807-11, 66220-807-22, 66220-810-11, 66220-810-22, 66220-812-11, 66220-812-22, 66220-815-11, 66220-815-22, 66220-817-11, 66220-817-22, 66220-820-11, 66220-820-22, 66220-822-11, 66220-822-22, 66220-825-11, 66220-825-22, 68382-775-60, 68382-775-16, 68382-775-01, 68382-775-05, 68382-775-10, 68382-775-77, 0555-0572-02, 0555-0572-35, 16729-277-30, 16729-277-03, 16729-277-35, 69238-1423-6, 69238-1423-1, 0143-9519-10, 0143-9518-01, 0143-9517-01, 0143-9516-01, 61703-408-41, 70771-1058-3, 70771-1058-9, 70771-1058-1, 70771-1058-5, 70771-1058-0, 70771-1058-2, 70771-1058-7, 16729-486-36, 16729-486-01, 54436-075-01, 54436-075-02, 54436-075-04, 54436-010-01, 54436-010-03, 54436-010-02, 54436-010-04, 54436-012-01, 54436-012-03, 54436-012-02, 54436-012-04, 54436-015-01, 54436-015-03, 54436-015-02, 54436-015-04, 54436-017-01, 54436-017-03, 54436-017-02, 54436-017-04, 54436-020-01, 54436-020-03, 54436-020-02, 54436-020-04, 54436-022-01, 54436-022-03, 54436-022-02, 54436-022-04, 54436-025-01, 54436-025-03, 54436-025-02, 54436-025-04, 58406-435-01, 58406-435-04, 58406-445-01, 58406-445-04, 58406-425-41, 58406-425-34, 58406-424-01, 58406-910-01, 58406-455-01, 58406-455-04, 58406-456-01, 58406-456-04, 58406-446-01, 58406-446-04, 58406-021-01, 58406-021-04, 58406-032-01, 58406-032-04, 58406-010-01, 58406-010-04, 58406-044-01, 58406-044-04, 58406-055-04, 52652-5001-1, 33342-015-10, 33342-015-12, 33342-016-10, 33342-016-12,
Patient Weight(kg): 2.82
Reporter Country: US
Individual Submitting: Consumer or non-health professional
Expedited?: Expedited

Patient Reaction: Ankyloglossia congenital, Foetal exposure during pregnancy,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
TRUVADA UNK Transplacental Not applicable Suspect drug ANTIRETROVIRAL THERAPY
NORVIR UNK Transplacental Not applicable Suspect drug ANTIRETROVIRAL THERAPY 2013-10-22
ISENTRESS UNK Transplacental Not applicable Suspect drug ANTIRETROVIRAL THERAPY
PREZISTA UNK Transplacental Not applicable Suspect drug ANTIRETROVIRAL THERAPY 2013-10-22

Drug Info:

Generic Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE RITONAVIR RALTEGRAVIR DARUNAVIR
Pharmacologic Class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Application Number: NDA021752 NDA020659 NDA022417 NDA209512 NDA022145 NDA203045 NDA205786 NDA021976 NDA202895

SPL ID: b4b9ab85-a958-450c-8c65-38411a1f7d8b, 3ed2a506-7b2a-8787-d093-941b0f35bcf4, 9434823c-41b1-4536-91eb-45bb4094fdf8, f4fed136-638c-11ea-959a-33fefb2ca371,
SPL Set ID: 54e82b13-a037-49ed-b4b3-030b37c0ecdd, 2849298e-de6e-47bb-8194-56e075b33fc3, 89a5ec53-d956-4329-8004-0f40f51c88a3, 814301f9-c990-46a5-b481-2879a521a16f,

Patient Weight(kg):
Reporter Country: GB
Individual Submitting: Other health professional
Expedited?: Expedited

Patient Reaction: Upper gastrointestinal haemorrhage,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
NAPROXEN PATIENT TOOK 500MG MORNING + 250MG MIDDAY WHEN REQUIRED. Oral Drug withdrawn Suspect drug GOUT 2014-02-07 2014-02-13
DOXAZOCIN 4 MG, QD Oral Unknown Concomitant drug HYPERTENSION
RAMIPRIL 5 MG, QD Oral Unknown Concomitant drug HYPERTENSION
LERCANIDIPINE 10 MG, QD Oral Unknown Concomitant drug HYPERTENSION
SIMVASTATIN 40 MG, QD Oral Unknown Concomitant drug HYPERCHOLESTEROLAEMIA

Drug Info:

Generic Name: NAPROXEN NAPROXEN SODIUM NAPROXEN SODIUM 220 MG RAMIPRIL SIMVASTATIN
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: ANDA091416 NDA018965 ANDA204872 ANDA090545 ANDA091432 ANDA075927 ANDA091305 ANDA212705 ANDA091353 ANDA212517 ANDA078620 ANDA079096 ANDA074190 ANDA078250 NDA020067 NDA017581 ANDA075227 ANDA200429 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191 NDA206679 ANDA078155 ANDA077691 ANDA078103 ANDA090383 ANDA078034 ANDA077837 ANDA206557 NDA019766 ANDA200895 ANDA076052 ANDA078425 ANDA077752

SPL ID: 6fa09e97-8e2d-4d74-9490-3eb2169820f6, 7ee67f65-ef72-4290-a6bf-66db51ae943f, bfb03c1a-e7d3-4c52-b210-7d102ea7e3b4, b9f90c5a-b4dd-4e2c-b34a-1ad98e25bbc7, 8dead001-8f44-435e-9519-831913ac81b7, 6851dcf4-841e-4ab7-ae01-ccbe7fc444c6, ff01265e-1f63-481d-952c-735ce94a6677, 2513454d-a89e-4bb4-ba9e-c344046bbafe, 509fffe2-2bab-4ae4-8c53-520e1c5eff68, a3992da9-dd4a-4086-9653-2ba4716d2b5e, a8e8dff8-2f92-4aa3-8e2f-c3b94838565d, f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e, dcfba184-4397-4934-9392-2ac42f65e9e5, 8758ca32-6b2d-0e32-e053-2995a90acb7c, 4d5782dd-681f-49ca-a28e-535b68c4dfa1, 0181ec15-0150-41d7-9ee1-face10165445, b795cec2-a6e8-47c1-883a-bc8ab2afa5b0, 849cee95-b48f-45b8-86e0-74cdce31d551, 835e51be-bb22-41ae-8426-a0085b4a2e9d, 408ef299-921c-42b6-8353-d96fd5bec102, 91caaf03-2568-4da2-8737-8f4a0cc95b26, 77d2030d-4699-2117-e053-2a91aa0a6dc8, 3cf69408-c2d6-453f-ab49-3007f220dd70, 0aa005eb-b5a2-4f9b-9fa8-0c543a7752b3, 9a61f591-394d-7f1b-e053-2995a90a29c4, c826cad5-6780-4047-aaca-bf97dd069306, 73fe2dce-5cdd-4338-bd9f-00c086c3d57a, 24aaa278-52f3-4015-ac5b-5ce2ae64ff7d, 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc257d2-f5aa-4353-b61b-5827e44040c9, 382682be-9132-4a2f-bd71-644ff7d34f3c, bd18cbe0-7b1f-45ac-8d43-0443c9688509, 9eac2e75-3766-4394-a435-547cdc840b42, be5e151f-7909-4ca2-b3f2-a55280d8788b, ac6c9f3c-315c-42c2-8856-b2808e5f24d2, 3653d3cf-129c-2503-e054-00144ff8d46c, 37b64bf3-8bdc-4e6e-843f-9c87f24b8376, aa55f661-7c12-49f8-919d-d857ea9280b1, dbad7714-2c93-47e2-890e-0b94a45c44d7, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, f4987a92-7a39-4775-9873-659280646da1, 9ca7716b-2236-623f-f9f7-19bf7b29ea85, 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 4534ff2e-b34b-4c56-b496-5cd7a76aa4e7, 2d1fb16c-7318-4550-901f-7b286fb1c82b, b1884b7b-9294-a2b1-e053-2a95a90aedae, 4ea81ae0-c11c-fb4b-7d9a-99bcc5e17dfe, 10928f6e-d9d3-4481-b9de-4d6ab584f6a8, fd85fb32-2847-4b3a-9332-9e297f3a8d4a, 8843c943-7fc2-41cc-e053-2a95a90a2850, 046a3f29-60d7-4544-9ea0-f91be4a2981c, ed5bb483-f814-41b0-8185-aca2e25048d0, 3c229a59-320d-4708-bb6b-5a5ff06fb409, e84eacda-08e3-4ffb-b741-5da71454974b, 84334c5d-1663-972c-5d96-03eb1be16f64, f6845fa6-57b6-47dd-b0b2-87502e254b42,
SPL Set ID: 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8, bc979c90-5853-4a95-8402-ba6b57100b17, 1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0, 0f1e4e8d-41fe-483f-9e80-7d3969bb891a, 8dead001-8f44-435e-9519-831913ac81b7, 4023f2a0-896b-45f9-9f62-6c12d318ec66, 2718e0b7-1ce6-457e-bee9-11b634dfd353, f9b4173d-7836-4d7d-b149-1d96f9377ad0, 46dbdb95-a0d0-4410-8d64-b22763b12af7, a9549a47-3fa4-4a2b-95ac-b00e43aedae7, 985aedc1-8b3c-4cb4-af13-7203a2b57ab7, 287a381a-df7e-4e93-b097-1efde8a5f120, e06c2b43-9882-442e-8413-10d9a33aecb9, 81417810-8a34-c859-e053-2a91aa0a6507, 81e22c1f-f94d-46e9-8b7d-72dc2518319e, 94e84499-d536-457c-96e6-7569e8a179c4, 060ce9fc-9951-4342-8ff4-8218c46be673, 11b45955-a198-4668-b623-c010accd2618, 82412133-c11a-4905-a119-965f44de10b7, 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9, c43a43e2-e867-448d-8f59-3efc7c077cbc, 4350a2d9-5228-460e-b7b1-27e8fa846787, 0728935b-19fc-4a10-aeba-29c42ce7f472, 8bff5df5-d856-4237-b6a8-ae445b454844, 9a61d544-e46d-6703-e053-2a95a90a32fd, bc6a65ea-9fdf-42a4-972d-5a602d9a0a61, f9a4752b-fdb0-4e26-a024-0c98d55f9dca, 0e5315bc-c02f-4749-be69-b5b528327d58, a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc34cd8-86e6-4034-73bd-4263a68ba046, ee92b5bb-77d5-47cd-a8b1-d5f383b94311, 7e9e84f7-ff47-463d-bf47-7a9745960aae, 055bb582-67cd-425a-8823-d543c14305ce, d5c58fb5-b415-4567-9790-55631705c5cd, 1e1dfacf-b831-4743-a874-9a5e5ef8a120, e4144b15-406d-4169-9ca7-12a6fce38263, 3c358a20-9abb-4fc0-afb9-400e3c621fe2, d6d57158-e8f9-4c91-8317-0374e0c87d33, 6eb70bb3-1403-4b28-8da5-7756a12d3626, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, b7e49f05-6d4f-465a-b0d7-f704466a2e52, 0f33b72d-70c6-18fe-07b6-8e36749c84e0, 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376351b-f1a0-43e5-a0b4-533072c49f39, 3e48217f-8175-4e9b-9fd0-909be4bbba95, 5c1c694c-4b08-469e-b538-08e69df06146, 7b325108-6940-50a7-96b4-822a5206e568, 4724dbb4-3613-4e6a-948f-a43d34f97f06, 30fbaf9e-01cf-492a-b44f-dc81c17d7647, 6a365728-e31a-428f-9718-d1a34d686186, fdbfe194-b845-42c5-bb87-a48118bc72e7, 751b79c6-bba8-4d29-b69c-a2ac6453fec8, 1c5178c9-270f-4a5b-a52b-68a56972f035, 881eb80b-712e-4aa2-bd23-290a3e5db6cd, d9a1a7c5-d806-4dbd-a201-5e73790d078b, 9a3d815e-ab40-4c1c-a065-281dac6685a6,

Product NDC:
(NLM DailyMed Link)
25000-138, 25000-139, 25000-140, 71297-200, 46122-564, 69168-361, 69543-425, 69543-426, 46122-562, 53746-188, 53746-189, 53746-190, 71511-701, 76282-340, 76282-341, 76282-342, 69097-853, 69097-854, 69097-855, 69238-1730, 61010-4410, 69097-851, 69097-852, 0363-9609, 50228-434, 50228-435, 50228-436, 65841-676, 65841-677, 65841-678, 50844-271, 68134-201, 50844-261, 68462-188, 68462-189, 68462-190, 68462-178, 68462-179, 65162-188, 65162-189, 65162-190, 49483-617, 49483-618, 49483-619, 69784-500, 69784-505, 69784-501, 69784-550, 69437-316, 69437-415, 69437-416, 69437-203, 57896-954, 0093-1005, 0093-1006, 68382-012, 68382-013, 68382-014, 65862-520, 65862-521, 65862-522, 68180-589, 68180-588, 68180-590, 68180-591, 65841-655, 65841-656, 65841-657, 65841-658, 61570-110, 61570-111, 61570-112, 61570-120, 68382-374, 68382-375, 68382-376, 68382-377, 0054-0106, 0054-0107, 0054-0108, 0054-0109, 68382-144, 68382-145, 68382-146, 68382-147, 57237-222, 57237-223, 57237-224, 57237-225, 76282-670, 76282-671, 76282-672, 76282-673, 16729-152, 16729-153, 16729-154, 16729-155, 65841-699, 65841-700, 65841-701, 65841-702, 65862-474, 65862-475, 65862-476, 65862-477, 68001-140, 68001-142, 68001-143, 68001-141, 68001-428, 68001-429, 68001-430, 68001-431, 62135-271, 62135-272, 62135-273, 62135-274, 55111-438, 55111-439, 55111-440, 55111-441, 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 16714-681, 16714-682, 16714-683, 16714-684, 16714-685, 68180-464, 68180-482, 68180-478, 68180-479, 68180-480, 68180-481, 68180-465, 42571-005, 42571-010, 42571-020, 42571-040, 42571-080, 70377-001, 70377-002, 70377-003, 70377-004, 70377-005, 65862-050, 65862-051, 65862-052, 65862-053, 65862-054, 68382-065, 68382-066, 68382-067, 68382-068, 68382-069, 42658-108, 42658-109, 42658-110, 42658-111, 0006-0543, 0006-0749, 0006-0740, 0006-0735, 31722-510, 31722-511, 31722-512, 31722-513, 31722-514, 54458-932, 54458-934, 54458-933, 65841-065, 65841-066, 65841-067, 65841-068, 65841-069, 55111-197, 55111-198, 55111-199, 55111-200, 55111-268, 52343-021, 52343-022, 52343-023, 52343-024, 52343-025,
Package NDC:
(NLM DailyMed Link)
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Patient Weight(kg): 81
Reporter Country: CA
Individual Submitting: Physician
Expedited?: Expedited

Patient Reaction: Subdural haematoma,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
RAMIPRIL. Unknown Concomitant drug HYPERTENSION 1995-01-01
WARFARIN Unknown Concomitant drug THROMBOSIS PROPHYLAXIS 1982-01-01
LIPITOR Unknown Concomitant drug BLOOD CHOLESTEROL INCREASED 2010-02-01
TAMSULOSIN Unknown Concomitant drug URINARY RETENTION 2014-03-19 2014-03-21
ADALAT CC Unknown Concomitant drug HYPERTENSION 2010-02-01
DIPYRIDAMOLE. Unknown Concomitant drug HYPERTENSION 1982-01-01
SYNTHROID Unknown Concomitant drug HYPOTHYROIDISM 2001-01-01
VISMODEGIB DATE OF LAST DOSE PRIOR TO SAE: 06/FEB/2014. Oral Suspect drug BASAL CELL CARCINOMA 2013-04-03 2014-02-06
PHYTONADIONE. Intravenous (not otherwise specified) Concomitant drug THROMBOSIS 2014-02-15 2014-02-15

Drug Info:


SPL ID: 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc257d2-f5aa-4353-b61b-5827e44040c9, 382682be-9132-4a2f-bd71-644ff7d34f3c, bd18cbe0-7b1f-45ac-8d43-0443c9688509, 9eac2e75-3766-4394-a435-547cdc840b42, be5e151f-7909-4ca2-b3f2-a55280d8788b, ac6c9f3c-315c-42c2-8856-b2808e5f24d2, 3653d3cf-129c-2503-e054-00144ff8d46c, 37b64bf3-8bdc-4e6e-843f-9c87f24b8376, aa55f661-7c12-49f8-919d-d857ea9280b1, dbad7714-2c93-47e2-890e-0b94a45c44d7, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, f4987a92-7a39-4775-9873-659280646da1, 9ca7716b-2236-623f-f9f7-19bf7b29ea85, 45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 382d1213-6f7d-4c90-83ff-3b4fc6f96dda, eec18253-d3cc-4f04-9d88-d29b6a7a81d2, b91f02b7-092e-35b9-b4d9-8a1a47cbf843, baa2cb6d-2b97-4ad3-a5fc-bad3b8bc6175, 49696b8e-4006-456b-b43c-ef3ec3e7538d, 61d8366d-0637-48b8-a36c-89517b4fa6a9, 9a67bb27-cb47-4a1d-e053-2a95a90a0ee2, be39441a-182c-4e31-8fc3-e9d85a99cbba, db21fc0c-4a2d-9922-39bd-8128e429bebc, ffffad90-4dfa-4f07-8a99-80a9376be11f, 9be294f3-4cc0-4ce8-9dd2-b05b47ae8602, 741a214d-9c35-ab72-08bd-6ff23c73024e, a8aedb94-c145-40d7-ba1d-20c536250a45, d27a1f22-5549-4b33-b561-6c00e688cea7, 112734e5-5b3c-4731-a02c-2539d6da6e1f, 90c52861-852b-4a55-bfd7-be70a95882cc, e0b8502d-5b21-499d-9d20-461f175250a2, 49fe5913-0665-4299-98c3-13f2a92be2d2, e6a71caf-f186-4ba2-b29b-79141bc46253,
SPL Set ID: a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc34cd8-86e6-4034-73bd-4263a68ba046, ee92b5bb-77d5-47cd-a8b1-d5f383b94311, 7e9e84f7-ff47-463d-bf47-7a9745960aae, 055bb582-67cd-425a-8823-d543c14305ce, d5c58fb5-b415-4567-9790-55631705c5cd, 1e1dfacf-b831-4743-a874-9a5e5ef8a120, e4144b15-406d-4169-9ca7-12a6fce38263, 3c358a20-9abb-4fc0-afb9-400e3c621fe2, d6d57158-e8f9-4c91-8317-0374e0c87d33, 6eb70bb3-1403-4b28-8da5-7756a12d3626, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, b7e49f05-6d4f-465a-b0d7-f704466a2e52, 0f33b72d-70c6-18fe-07b6-8e36749c84e0, c0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760, c6e131fe-e7df-4876-83f7-9156fc4e8228, ca68879c-0214-4d7c-93b0-bdaf8ef23f8e, 6093dcd9-82d2-414f-8507-eda22c14f626, 004bada0-dbf7-4a94-8792-6833d7eeda2b, 1b82871b-f60b-4485-9a45-026aeb18b484, 0146650f-d6e6-4a9c-8925-415b3c92b0e7, 312aadb1-435c-4aa7-8e46-6506cedacaa0, 1e11ad30-1041-4520-10b0-8f9d30d30fcc, eb368bb6-80e3-4df9-8a85-91df0a2ada6a, 6c992275-b040-42d0-9eff-570dce4272fe, 02445c07-7b4b-cd70-54e8-ebefc814f547, e0b0c8f1-75be-4f25-898a-7b97b608c615, e8808230-2c44-44c6-8cab-8f29b6b34051, 54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d, 5be7bb0a-dddb-4cb4-bf89-a8fafb726c83, fa26f747-c64e-4090-a0cf-de3d3d9b004c, 4b352b5f-32d6-4c28-b58c-b34ea2b78a87, 5429b58b-ec2b-4a18-95d9-a9d804321192,

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(NLM DailyMed Link)
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65862-475-01, 65862-475-05, 65862-475-99, 65862-475-10, 65862-476-30, 65862-476-01, 65862-476-05, 65862-476-99, 65862-476-10, 65862-477-30, 65862-477-01, 65862-477-05, 65862-477-99, 65862-477-10, 68001-140-04, 68001-142-00, 68001-142-03, 68001-143-00, 68001-143-03, 68001-141-00, 68001-141-03, 68001-428-00, 68001-429-00, 68001-430-00, 68001-430-03, 68001-431-00, 68001-431-03, 62135-271-01, 62135-271-30, 62135-272-01, 62135-272-05, 62135-273-01, 62135-273-05, 62135-274-01, 62135-274-05, 55111-438-30, 55111-438-60, 55111-438-90, 55111-438-01, 55111-438-05, 55111-438-10, 55111-438-79, 55111-438-78, 55111-439-30, 55111-439-60, 55111-439-90, 55111-439-01, 55111-439-05, 55111-439-10, 55111-439-79, 55111-439-78, 55111-440-30, 55111-440-60, 55111-440-90, 55111-440-01, 55111-440-05, 55111-440-10, 55111-440-79, 55111-440-78, 55111-441-30, 55111-441-60, 55111-441-90, 55111-441-01, 55111-441-05, 55111-441-10, 55111-441-79, 55111-441-78, 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329-10, 76282-330-01, 76282-330-10, 76282-331-01, 76282-331-10, 76282-332-01, 76282-332-10, 76282-333-01, 76282-333-10, 76282-334-01, 76282-335-01, 65162-761-10, 65162-761-11, 65162-761-50, 65162-762-10, 65162-762-11, 65162-762-50, 65162-763-10, 65162-763-11, 65162-763-50, 65162-764-10, 65162-764-11, 65162-764-50, 65162-765-10, 65162-765-11, 65162-765-50, 65162-766-10, 65162-766-11, 65162-766-50, 65162-767-10, 65162-767-11, 65162-767-50, 65162-768-10, 65162-768-11, 65162-768-50, 65162-769-10, 65162-769-11, 65162-769-50, 0071-0155-23, 0071-0155-34, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156-94, 0071-0156-40, 0071-0156-10, 0071-0156-96, 0071-0157-23, 0071-0157-73, 0071-0157-88, 0071-0157-40, 0071-0157-97, 0071-0158-23, 0071-0158-73, 0071-0158-88, 0071-0158-92, 0597-0017-01, 0597-0018-01, 0597-0019-01, 0641-2569-41, 0641-2569-44, 68382-187-01, 68382-187-05, 68382-187-10, 68382-187-77, 68382-188-01, 68382-188-05, 68382-188-10, 68382-188-77, 68382-189-01, 68382-189-05, 68382-189-10, 68382-189-77, 0527-1461-01, 0527-1461-05, 0527-1461-10, 0527-1462-01, 0527-1462-05, 0527-1462-10, 0527-1463-01, 0527-1463-05, 0527-1463-10, 64980-133-01, 64980-133-10, 64980-134-01, 64980-134-10, 64980-135-01, 64980-135-10, 65841-662-01, 65841-662-05, 65841-662-10, 65841-662-77, 65841-663-01, 65841-663-05, 65841-663-10, 65841-663-77, 65841-664-01, 65841-664-05, 65841-664-10, 65841-664-77, 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341-72, 0074-4552-13, 0074-4552-90, 0074-4552-19, 0074-4552-11, 0074-4552-71, 0074-4552-72, 0074-5182-13, 0074-5182-90, 0074-5182-71, 0074-5182-19, 0074-5182-11, 0074-5182-72, 0074-6624-13, 0074-6624-90, 0074-6624-19, 0074-6624-11, 0074-6624-71, 0074-6624-72, 0074-6594-13, 0074-6594-90, 0074-6594-71, 0074-6594-19, 0074-6594-72, 0074-9296-13, 0074-9296-90, 0074-9296-19, 0074-9296-71, 0074-9296-72, 0074-7068-13, 0074-7068-90, 0074-7068-71, 0074-7068-19, 0074-7068-11, 0074-7068-72, 0074-3727-13, 0074-3727-90, 0074-3727-71, 0074-3727-19, 0074-3727-72, 0074-7069-90, 0074-7069-71, 0074-7069-19, 0074-7069-11, 0074-7069-72, 0074-7070-13, 0074-7070-90, 0074-7070-71, 0074-7070-19, 0074-7070-72, 0074-7148-90, 0074-7148-19, 0074-7148-71, 0074-7148-11, 0074-7148-72, 50242-140-01, 50242-140-86, 70710-1014-1, 70710-1014-2, 70710-1014-4, 43598-405-11, 43598-405-16, 76329-1240-1, 0409-9157-31, 0409-9157-50, 0409-9157-01, 0409-9157-25, 0409-9158-31, 0409-9158-50, 0409-9158-01, 0409-9158-25, 69238-1051-3, 69238-1051-1, 0187-1704-05, 70771-1318-1, 70771-1318-2, 70771-1318-4, 68682-170-05, 68682-170-30, 16714-973-01,
Patient Weight(kg):
Reporter Country: US
Individual Submitting: Consumer or non-health professional
Expedited?: Not expedited

Patient Reaction: Tremor, Tremor, Atrial fibrillation, Tremor, Tremor,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
DEPAKOTE 750 MILLIGRAMS DAILY; 250MG IN THE MORNING AND 500MG AT NIGHT; PEACH COLORED TABLETS Oral Dose not changed Suspect drug EPILEPSY 1991
KEPPRA Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
KLONOPIN Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
ELOQUIS Concomitant drug ATRIAL FIBRILLATION 201307
RAMIPRIL Concomitant drug ATRIAL FIBRILLATION 201307
AMIODARONE Concomitant drug ATRIAL FIBRILLATION 201307
CALCIUM Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION

Drug Info:

Generic Name: DIVALPROEX SODIUM LEVETIRACETAM CLONAZEPAM RAMIPRIL
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: NDA021168 NDA018723 NDA019680 NDA021872 NDA021505 NDA021035 NDA022285 NDA017533 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191

SPL ID: bda1168f-9cb8-cfc6-ccea-f576f45e25a6, 3c11ce81-9241-56ec-0783-7843408c10b9, f636288c-9172-59d7-ccc9-c9ae14193d50, 4a48c061-40c9-41d9-be30-e9521c3e03b5, f5f32bff-c998-43b5-920c-02f3fea3b46b, d6d84379-3c2f-4d49-a302-a91e113fcad2, f46c5526-1307-4c82-8fe6-5a53cfa3485f, 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc257d2-f5aa-4353-b61b-5827e44040c9, 382682be-9132-4a2f-bd71-644ff7d34f3c, bd18cbe0-7b1f-45ac-8d43-0443c9688509, 9eac2e75-3766-4394-a435-547cdc840b42, be5e151f-7909-4ca2-b3f2-a55280d8788b, ac6c9f3c-315c-42c2-8856-b2808e5f24d2, 3653d3cf-129c-2503-e054-00144ff8d46c, 37b64bf3-8bdc-4e6e-843f-9c87f24b8376, aa55f661-7c12-49f8-919d-d857ea9280b1, dbad7714-2c93-47e2-890e-0b94a45c44d7, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, f4987a92-7a39-4775-9873-659280646da1, 9ca7716b-2236-623f-f9f7-19bf7b29ea85,
SPL Set ID: 0dc024ce-efc8-4690-7cb5-639c728fccac, 08a65cf4-7749-4ceb-6895-8f4805e2b01f, 4619aff4-0f80-444f-858d-42e4137aa809, c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e, 3ca9df05-a506-4ec8-a4fe-320f1219ab21, 2919e43b-69a8-434c-a2d2-1f3ecd7554c0, 542f22e8-dad2-47a8-93b6-30936715d73b, a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc34cd8-86e6-4034-73bd-4263a68ba046, ee92b5bb-77d5-47cd-a8b1-d5f383b94311, 7e9e84f7-ff47-463d-bf47-7a9745960aae, 055bb582-67cd-425a-8823-d543c14305ce, d5c58fb5-b415-4567-9790-55631705c5cd, 1e1dfacf-b831-4743-a874-9a5e5ef8a120, e4144b15-406d-4169-9ca7-12a6fce38263, 3c358a20-9abb-4fc0-afb9-400e3c621fe2, d6d57158-e8f9-4c91-8317-0374e0c87d33, 6eb70bb3-1403-4b28-8da5-7756a12d3626, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, b7e49f05-6d4f-465a-b0d7-f704466a2e52, 0f33b72d-70c6-18fe-07b6-8e36749c84e0,

Package NDC:
(NLM DailyMed Link)
0074-3826-13, 0074-3826-11, 0074-7126-13, 0074-7126-53, 0074-7126-11, 0074-7126-72, 0074-6212-13, 0074-6214-13, 0074-6214-53, 0074-6215-13, 0074-6215-53, 0074-6114-13, 0074-6114-11, 50474-002-63, 50474-594-40, 50474-595-40, 50474-596-40, 50474-597-66, 50474-001-48, 50474-598-66, 50474-599-66, 0004-0068-01, 0004-0068-32, 0004-0058-01, 0004-0058-32, 0004-0098-01, 68180-588-01, 68180-588-09, 68180-588-02, 68180-589-01, 68180-589-09, 68180-589-02, 68180-590-01, 68180-590-09, 68180-590-02, 68180-591-01, 68180-591-09, 68180-591-02, 65841-655-06, 65841-655-16, 65841-655-01, 65841-655-05, 65841-655-30, 65841-656-06, 65841-656-16, 65841-656-01, 65841-656-05, 65841-656-30, 65841-657-06, 65841-657-16, 65841-657-01, 65841-657-05, 65841-657-30, 65841-658-06, 65841-658-16, 65841-658-01, 65841-658-05, 65841-658-30, 61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01, 68382-374-06, 68382-374-16, 68382-374-01, 68382-374-05, 68382-374-10, 68382-374-77, 68382-375-06, 68382-375-16, 68382-375-01, 68382-375-05, 68382-375-10, 68382-375-77, 68382-376-06, 68382-376-16, 68382-376-01, 68382-376-05, 68382-376-10, 68382-376-77, 68382-377-06, 68382-377-16, 68382-377-01, 68382-377-05, 68382-377-10, 68382-377-77, 0054-0106-25, 0054-0107-29, 0054-0107-25, 0054-0107-20, 0054-0108-25, 0054-0108-29, 0054-0108-20, 0054-0109-25, 0054-0109-29, 68382-144-06, 68382-144-16, 68382-144-01, 68382-144-05, 68382-144-30, 68382-144-77, 68382-145-06, 68382-145-16, 68382-145-01, 68382-145-05, 68382-145-30, 68382-145-77, 68382-146-06, 68382-146-16, 68382-146-01, 68382-146-05, 68382-146-30, 68382-146-77, 68382-147-06, 68382-147-16, 68382-147-01, 68382-147-05, 68382-147-30, 68382-147-77, 57237-222-30, 57237-222-01, 57237-223-01, 57237-223-05, 57237-224-01, 57237-224-05, 57237-225-01, 57237-225-05, 76282-670-01, 76282-671-01, 76282-672-01, 76282-673-01, 16729-152-01, 16729-152-16, 16729-153-01, 16729-153-16, 16729-154-01, 16729-154-16, 16729-155-01, 16729-155-16, 65841-699-06, 65841-699-16, 65841-699-01, 65841-699-05, 65841-699-10, 65841-699-77, 65841-700-06, 65841-700-16, 65841-700-01, 65841-700-05, 65841-700-10, 65841-700-77, 65841-701-06, 65841-701-16, 65841-701-01, 65841-701-05, 65841-701-10, 65841-701-77, 65841-702-06, 65841-702-16, 65841-702-01, 65841-702-05, 65841-702-10, 65841-702-77, 65862-474-30, 65862-474-01, 65862-474-99, 65862-474-10, 65862-475-30, 65862-475-01, 65862-475-05, 65862-475-99, 65862-475-10, 65862-476-30, 65862-476-01, 65862-476-05, 65862-476-99, 65862-476-10, 65862-477-30, 65862-477-01, 65862-477-05, 65862-477-99, 65862-477-10, 68001-140-04, 68001-142-00, 68001-142-03, 68001-143-00, 68001-143-03, 68001-141-00, 68001-141-03, 68001-428-00, 68001-429-00, 68001-430-00, 68001-430-03, 68001-431-00, 68001-431-03, 62135-271-01, 62135-271-30, 62135-272-01, 62135-272-05, 62135-273-01, 62135-273-05, 62135-274-01, 62135-274-05, 55111-438-30, 55111-438-60, 55111-438-90, 55111-438-01, 55111-438-05, 55111-438-10, 55111-438-79, 55111-438-78, 55111-439-30, 55111-439-60, 55111-439-90, 55111-439-01, 55111-439-05, 55111-439-10, 55111-439-79, 55111-439-78, 55111-440-30, 55111-440-60, 55111-440-90, 55111-440-01, 55111-440-05, 55111-440-10, 55111-440-79, 55111-440-78, 55111-441-30, 55111-441-60, 55111-441-90, 55111-441-01, 55111-441-05, 55111-441-10, 55111-441-79, 55111-441-78,
Patient Weight(kg):
Reporter Country: GB
Individual Submitting: Consumer or non-health professional
Expedited?: Expedited

Patient Reaction: Musculoskeletal stiffness, Myalgia,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
RAMIPRIL UNK Unknown Drug withdrawn Suspect drug HYPERTENSION

Drug Info:

Generic Name: RAMIPRIL
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191

SPL ID: 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc257d2-f5aa-4353-b61b-5827e44040c9, 382682be-9132-4a2f-bd71-644ff7d34f3c, bd18cbe0-7b1f-45ac-8d43-0443c9688509, 9eac2e75-3766-4394-a435-547cdc840b42, be5e151f-7909-4ca2-b3f2-a55280d8788b, ac6c9f3c-315c-42c2-8856-b2808e5f24d2, 3653d3cf-129c-2503-e054-00144ff8d46c, 37b64bf3-8bdc-4e6e-843f-9c87f24b8376, aa55f661-7c12-49f8-919d-d857ea9280b1, dbad7714-2c93-47e2-890e-0b94a45c44d7, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, f4987a92-7a39-4775-9873-659280646da1, 9ca7716b-2236-623f-f9f7-19bf7b29ea85,
SPL Set ID: a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc34cd8-86e6-4034-73bd-4263a68ba046, ee92b5bb-77d5-47cd-a8b1-d5f383b94311, 7e9e84f7-ff47-463d-bf47-7a9745960aae, 055bb582-67cd-425a-8823-d543c14305ce, d5c58fb5-b415-4567-9790-55631705c5cd, 1e1dfacf-b831-4743-a874-9a5e5ef8a120, e4144b15-406d-4169-9ca7-12a6fce38263, 3c358a20-9abb-4fc0-afb9-400e3c621fe2, d6d57158-e8f9-4c91-8317-0374e0c87d33, 6eb70bb3-1403-4b28-8da5-7756a12d3626, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, b7e49f05-6d4f-465a-b0d7-f704466a2e52, 0f33b72d-70c6-18fe-07b6-8e36749c84e0,

RxNorm Code:
(MedlinePlus Connect Link)
198188, 198189, 261962, 845488, 104384, 104385, 260333, 845489, 251856, 251857, 401965, 401968,
Package NDC:
(NLM DailyMed Link)
68180-588-01, 68180-588-09, 68180-588-02, 68180-589-01, 68180-589-09, 68180-589-02, 68180-590-01, 68180-590-09, 68180-590-02, 68180-591-01, 68180-591-09, 68180-591-02, 65841-655-06, 65841-655-16, 65841-655-01, 65841-655-05, 65841-655-30, 65841-656-06, 65841-656-16, 65841-656-01, 65841-656-05, 65841-656-30, 65841-657-06, 65841-657-16, 65841-657-01, 65841-657-05, 65841-657-30, 65841-658-06, 65841-658-16, 65841-658-01, 65841-658-05, 65841-658-30, 61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01, 68382-374-06, 68382-374-16, 68382-374-01, 68382-374-05, 68382-374-10, 68382-374-77, 68382-375-06, 68382-375-16, 68382-375-01, 68382-375-05, 68382-375-10, 68382-375-77, 68382-376-06, 68382-376-16, 68382-376-01, 68382-376-05, 68382-376-10, 68382-376-77, 68382-377-06, 68382-377-16, 68382-377-01, 68382-377-05, 68382-377-10, 68382-377-77, 0054-0106-25, 0054-0107-29, 0054-0107-25, 0054-0107-20, 0054-0108-25, 0054-0108-29, 0054-0108-20, 0054-0109-25, 0054-0109-29, 68382-144-06, 68382-144-16, 68382-144-01, 68382-144-05, 68382-144-30, 68382-144-77, 68382-145-06, 68382-145-16, 68382-145-01, 68382-145-05, 68382-145-30, 68382-145-77, 68382-146-06, 68382-146-16, 68382-146-01, 68382-146-05, 68382-146-30, 68382-146-77, 68382-147-06, 68382-147-16, 68382-147-01, 68382-147-05, 68382-147-30, 68382-147-77, 57237-222-30, 57237-222-01, 57237-223-01, 57237-223-05, 57237-224-01, 57237-224-05, 57237-225-01, 57237-225-05, 76282-670-01, 76282-671-01, 76282-672-01, 76282-673-01, 16729-152-01, 16729-152-16, 16729-153-01, 16729-153-16, 16729-154-01, 16729-154-16, 16729-155-01, 16729-155-16, 65841-699-06, 65841-699-16, 65841-699-01, 65841-699-05, 65841-699-10, 65841-699-77, 65841-700-06, 65841-700-16, 65841-700-01, 65841-700-05, 65841-700-10, 65841-700-77, 65841-701-06, 65841-701-16, 65841-701-01, 65841-701-05, 65841-701-10, 65841-701-77, 65841-702-06, 65841-702-16, 65841-702-01, 65841-702-05, 65841-702-10, 65841-702-77, 65862-474-30, 65862-474-01, 65862-474-99, 65862-474-10, 65862-475-30, 65862-475-01, 65862-475-05, 65862-475-99, 65862-475-10, 65862-476-30, 65862-476-01, 65862-476-05, 65862-476-99, 65862-476-10, 65862-477-30, 65862-477-01, 65862-477-05, 65862-477-99, 65862-477-10, 68001-140-04, 68001-142-00, 68001-142-03, 68001-143-00, 68001-143-03, 68001-141-00, 68001-141-03, 68001-428-00, 68001-429-00, 68001-430-00, 68001-430-03, 68001-431-00, 68001-431-03, 62135-271-01, 62135-271-30, 62135-272-01, 62135-272-05, 62135-273-01, 62135-273-05, 62135-274-01, 62135-274-05, 55111-438-30, 55111-438-60, 55111-438-90, 55111-438-01, 55111-438-05, 55111-438-10, 55111-438-79, 55111-438-78, 55111-439-30, 55111-439-60, 55111-439-90, 55111-439-01, 55111-439-05, 55111-439-10, 55111-439-79, 55111-439-78, 55111-440-30, 55111-440-60, 55111-440-90, 55111-440-01, 55111-440-05, 55111-440-10, 55111-440-79, 55111-440-78, 55111-441-30, 55111-441-60, 55111-441-90, 55111-441-01, 55111-441-05, 55111-441-10, 55111-441-79, 55111-441-78,
Patient Weight(kg):
Reporter Country: US
Individual Submitting: Consumer or non-health professional
Expedited?: Not expedited

Patient Reaction: Flatulence, Abdominal distension, Diarrhoea,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
JAKAFI 20 MG, BID Oral Drug withdrawn Suspect drug MYELOFIBROSIS 201310
JAKAFI 5 MG, BID Oral Drug withdrawn Suspect drug 2013-11-01
LOVASTATIN Concomitant drug
OMEPRAZOLE Concomitant drug
RANITIDINE /00550802/ Concomitant drug
LEXAPRO Concomitant drug
DILTIAZEM Concomitant drug
RAMIPRIL Concomitant drug
METOPROLOL Concomitant drug
ALPRAZOLAM Concomitant drug
PRADAXA Concomitant drug

Drug Info:

Generic Name: RUXOLITINIB RUXOLITINIB LOVASTATIN OMEPRAZOLE OMEPRAZOLE MAGNESIUM ESCITALOPRAM OXALATE RAMIPRIL METOPROLOL TARTRATE METOPROLOL ALPRAZOLAM DABIGATRAN ETEXILATE MESYLATE
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: NDA202192 NDA202192 ANDA078296 ANDA075828 ANDA075991 NDA021316 ANDA075551 ANDA075636 NDA022032 ANDA210593 ANDA207891 ANDA075410 ANDA075757 ANDA206877 NDA209400 ANDA091352 ANDA078878 ANDA206582 ANDA207740 ANDA076515 ANDA076048 ANDA204012 ANDA211732 ANDA091672 ANDA078490 ANDA075576 ANDA203270 ANDA203481 NDA021323 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191 ANDA078950 ANDA091045 ANDA202871 ANDA207507 ANDA074342 NDA021434 ANDA203346 ANDA090871 NDA018276 ANDA078088 ANDA078056 ANDA078561 ANDA078387 ANDA074312 ANDA074112 ANDA074909 ANDA074215 ANDA074174 NDA022512
Manufacturer Name:
(Google Search)
Incyte Corporation Incyte Corporation Lupin Pharmaceuticals, Inc. Actavis Pharma, Inc. Carlsbad Technology, Inc. Covis Pharma Teva Pharmaceuticals USA, Inc. International Laboratories, LLC BluePoint Laboratories Eon Labs, Inc. Amerisource Bergen Costco Wholesale Company INNOVUS PHARMACEUTICALS, INC. OHM LABORATORIES INC. Lannett Company, Inc. Sandoz Inc Cardinal Health BJWC CVS Pharmacy, Inc. DISCOUNT DRUG MART L. Perrigo Company Aurohealth LLC Sam's West Inc Meijer Distribution Inc CVS Pharmacy H E B Fred's, Inc. Wal-Mart Stores Inc THE KROGER COMPANY Dolgencorp, LLC Ohm Laboratories Inc. Topco Associates LLC Lidl US LLC Cadila Healthcare Limited Chain Drug Consortium, LLC Rite Aid Corporation Walgreen Company Genomma Lab USA, Inc. Family Dollar Services Inc Supervalu Inc P & L Development, LLC American Sales Company Reliable 1 Laboratories LLC Perrigo New York Inc BluePoint Laboratories Harris Teeter, LLC Shopko Stores Operating Co., LLC Sun Pharmaceutical Industries, Inc. Big Lots Stores, Inc. Zydus Pharmaceuticals (USA) Inc. Gericare Pharmaceuticals Apotex Corp Rite Aid Harmon Stores Inc. Rugby Laboratories Major Pharmaceuticals Camber Pharmaceuticals, Inc. Safeway Camber Consumer Care Glenmark Pharmaceuticals Inc., USA Publix Super Markets Inc Save-A-Lot Food Stores Ltd Dr. Reddy's Laboratories Limited Thirty Madison Inc Strategic Sourcing Services LLC Aldi Inc NorthStar Rx LLC Target Corporation Kroger Company Family Dollar, Inc. Breckenridge Pharmaceutical, Inc. Humana Pharmacy, Inc. Bi-Mart Dr. Reddys Laboratories Inc Amazon.com Services LLC Aurobindo Pharma Limited Winco Foods, LLC. 7-Eleven Army & Air Force Exchange Service Best Choice Rising Health, LLC Wal-Mart Stores, Inc. GERICARE PHARMACEUTICALS Allergan, Inc. Lupin Pharmaceuticals, Inc. Cadila Healthcare Limited Pfizer Laboratories Div Pfizer Inc Zydus Pharmaceuticals (USA) Inc. West-Ward Pharmaceuticals Corp. Rising Health, LLC Exelan Pharmaceuticals, Inc. Accord Healthcare Inc. Aurobindo Pharma Limited BluePoint Laboratories Chartwell RX, LLC. Dr. Reddy's Laboratories Limited Baxter Healthcare Corporation Fresenius Kabi USA, LLC Alembic Pharmaceuticals Inc. Alembic Pharmaceuticals Limited Breckenridge Pharmaceutical, Inc. Actavis Pharma, Inc. Pharmacia and Upjohn Company LLC Aurobindo Pharma Limited Greenstone LLC H.J. Harkins Company, Inc. Par Pharmaceutical, Inc. Amneal Pharmaceuticals LLC Rising Pharmaceuticals, Inc. West-Ward Pharmaceuticals Corp. Sandoz Inc Mylan Pharmaceuticals Inc. Par Pharmaceutical Boehringer Ingelheim Pharmaceuticals Inc.

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Product NDC:
(NLM DailyMed Link)
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Package NDC:
(NLM DailyMed Link)
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Patient Weight(kg): 74
Reporter Country: DE
Individual Submitting: Physician
Expedited?: Expedited

Patient Reaction: Metastases to bone, Osteonecrosis of jaw,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
XGEVA 120 MG, Q4WK Subcutaneous Drug withdrawn Suspect drug METASTASES TO BONE 201208
AFINITOR 10 MG, QD Oral Suspect drug BREAST CANCER METASTATIC 2013-10-02
EXEMESTANE UNK Unknown Concomitant drug 2013-10-02
METFORMIN 900 MG, UNK Unknown Concomitant drug 2005
MIRTAZAPIN 30 MG, UNK Unknown Concomitant drug 2010
TRAMADOL Unknown Concomitant drug
RAMIPRIL 10 MG, UNK Unknown Concomitant drug 2005
BISOPROLOL 10 MG, UNK Unknown Concomitant drug 2005
PANTOZOL /01263204/ UNK Unknown Concomitant drug 2005

Drug Info:

Generic Name: DENOSUMAB EVEROLIMUS EXEMESTANE METFORMIN METFORMIN ER 500 MG METFORMIN ER 750 MG RAMIPRIL BISOPROLOL FUMARATE
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: BLA125320 NDA022334 NDA203985 ANDA200898 ANDA210323 NDA020753 ANDA077431 ANDA202602 ANDA209208 ANDA203315 ANDA211031 ANDA206421 ANDA200690 ANDA209674 ANDA209313 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191 ANDA075474

SPL ID: 92ed95b8-243b-4e2a-8f93-4d44d507c2c6, 438ec9ca-a281-41fd-8d9e-ffd90e871a23, 8b887eb4-4225-e465-e053-2a95a90aae7a, aa4cd4c7-4a52-4d5b-a921-12cac83610d8, 47a04c9b-920f-4627-9d94-fd48595ac1d7, 6c513bc0-1331-4f11-9d08-741b6c6d4f3d, 2d45a000-264d-403a-a2b8-a6145106ee52, fd84f573-4684-474c-99c5-491cb63684ff, 3843631e-c4d0-4454-8af3-8211d490e2af, b59a1dde-ecc0-4702-bdd9-9987e6d4b8c0, eb18191a-ed37-40dd-8da8-0a2011605726, 75eb10fe-ee49-45a6-90b6-a7fe982cc491, 57855f1d-910f-71df-8c03-6061964ea1b3, 40854c54-150e-4545-a099-db1d95b3edce, b1d71739-26c3-43d3-9088-60bef3689e74, b2db08b6-cee7-4be9-9796-55026c160b84, a353eff0-4b0c-2ec3-e053-2995a90ab079, 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc257d2-f5aa-4353-b61b-5827e44040c9, 382682be-9132-4a2f-bd71-644ff7d34f3c, bd18cbe0-7b1f-45ac-8d43-0443c9688509, 9eac2e75-3766-4394-a435-547cdc840b42, be5e151f-7909-4ca2-b3f2-a55280d8788b, ac6c9f3c-315c-42c2-8856-b2808e5f24d2, 3653d3cf-129c-2503-e054-00144ff8d46c, 37b64bf3-8bdc-4e6e-843f-9c87f24b8376, aa55f661-7c12-49f8-919d-d857ea9280b1, dbad7714-2c93-47e2-890e-0b94a45c44d7, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, f4987a92-7a39-4775-9873-659280646da1, 9ca7716b-2236-623f-f9f7-19bf7b29ea85, 17501604-23a3-40c4-a3ba-50bc9bda2555,
SPL Set ID: 628f0998-1206-4001-aeee-18133aa9f3bf, 2150f73a-179b-4afc-b8ce-67c85cc72f04, 88fb6543-383b-4195-a2c1-2673ac194f4b, abde1ccd-0ec9-40d4-b205-fbc00f5878b9, 69abd0ff-b200-4d1a-b14a-80e980a8e781, 2ecdb646-4d0f-4d1b-ac6a-9cb5deb9ac0d, f1bbe1bd-fa92-4fdd-88df-31ebcb200d37, f8bd17b4-5289-45bb-8095-de89dc8d39ed, 3573e3c9-ca05-413f-909f-93607a2ccb79, 4e3fd382-19f5-4ded-ab22-39d5b1b2f366, fab5468a-d5b7-45e3-b8b2-ed902fddd3a6, 11d5a86e-7861-43f1-ae04-84daa0de7888, 61d86c55-9946-273f-4f22-42d3fc33d143, cf066b7a-032a-416c-8d40-15ba581423e3, 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6ee6f8-9650-ff4f-e053-2991aa0acf19, a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc34cd8-86e6-4034-73bd-4263a68ba046, ee92b5bb-77d5-47cd-a8b1-d5f383b94311, 7e9e84f7-ff47-463d-bf47-7a9745960aae, 055bb582-67cd-425a-8823-d543c14305ce, d5c58fb5-b415-4567-9790-55631705c5cd, 1e1dfacf-b831-4743-a874-9a5e5ef8a120, e4144b15-406d-4169-9ca7-12a6fce38263, 3c358a20-9abb-4fc0-afb9-400e3c621fe2, d6d57158-e8f9-4c91-8317-0374e0c87d33, 6eb70bb3-1403-4b28-8da5-7756a12d3626, 45707435-4fc8-457e-9ff2-02d7be9b4a6e, b7e49f05-6d4f-465a-b0d7-f704466a2e52, 0f33b72d-70c6-18fe-07b6-8e36749c84e0, bba0bc2b-602f-4df1-a761-85bd3c80c7de,

Package NDC:
(NLM DailyMed Link)
55513-730-01, 0078-0566-61, 0078-0566-51, 0078-0567-61, 0078-0567-51, 0078-0594-61, 0078-0594-51, 0078-0620-61, 0078-0620-51, 0078-0626-61, 0078-0626-51, 0078-0627-61, 0078-0627-51, 0078-0628-61, 0078-0628-51, 44278-025-30, 69097-316-02, 59762-2858-1, 0054-0080-13, 68382-383-06, 0832-0595-30, 0378-5001-93, 51991-005-33, 70771-1374-3, 65162-240-03, 47781-108-30, 0009-7663-04, 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634-30, 50742-634-60, 50742-634-10, 70010-491-01, 70010-491-05, 70010-491-18, 70010-491-19, 70010-491-10, 70010-491-09, 70010-492-01, 70010-492-05, 70010-492-20, 70010-492-21, 70010-492-09, 68180-588-01, 68180-588-09, 68180-588-02, 68180-589-01, 68180-589-09, 68180-589-02, 68180-590-01, 68180-590-09, 68180-590-02, 68180-591-01, 68180-591-09, 68180-591-02, 65841-655-06, 65841-655-16, 65841-655-01, 65841-655-05, 65841-655-30, 65841-656-06, 65841-656-16, 65841-656-01, 65841-656-05, 65841-656-30, 65841-657-06, 65841-657-16, 65841-657-01, 65841-657-05, 65841-657-30, 65841-658-06, 65841-658-16, 65841-658-01, 65841-658-05, 65841-658-30, 61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01, 68382-374-06, 68382-374-16, 68382-374-01, 68382-374-05, 68382-374-10, 68382-374-77, 68382-375-06, 68382-375-16, 68382-375-01, 68382-375-05, 68382-375-10, 68382-375-77, 68382-376-06, 68382-376-16, 68382-376-01, 68382-376-05, 68382-376-10, 68382-376-77, 68382-377-06, 68382-377-16, 68382-377-01, 68382-377-05, 68382-377-10, 68382-377-77, 0054-0106-25, 0054-0107-29, 0054-0107-25, 0054-0107-20, 0054-0108-25, 0054-0108-29, 0054-0108-20, 0054-0109-25, 0054-0109-29, 68382-144-06, 68382-144-16, 68382-144-01, 68382-144-05, 68382-144-30, 68382-144-77, 68382-145-06, 68382-145-16, 68382-145-01, 68382-145-05, 68382-145-30, 68382-145-77, 68382-146-06, 68382-146-16, 68382-146-01, 68382-146-05, 68382-146-30, 68382-146-77, 68382-147-06, 68382-147-16, 68382-147-01, 68382-147-05, 68382-147-30, 68382-147-77, 57237-222-30, 57237-222-01, 57237-223-01, 57237-223-05, 57237-224-01, 57237-224-05, 57237-225-01, 57237-225-05, 76282-670-01, 76282-671-01, 76282-672-01, 76282-673-01, 16729-152-01, 16729-152-16, 16729-153-01, 16729-153-16, 16729-154-01, 16729-154-16, 16729-155-01, 16729-155-16, 65841-699-06, 65841-699-16, 65841-699-01, 65841-699-05, 65841-699-10, 65841-699-77, 65841-700-06, 65841-700-16, 65841-700-01, 65841-700-05, 65841-700-10, 65841-700-77, 65841-701-06, 65841-701-16, 65841-701-01, 65841-701-05, 65841-701-10, 65841-701-77, 65841-702-06, 65841-702-16, 65841-702-01, 65841-702-05, 65841-702-10, 65841-702-77, 65862-474-30, 65862-474-01, 65862-474-99, 65862-474-10, 65862-475-30, 65862-475-01, 65862-475-05, 65862-475-99, 65862-475-10, 65862-476-30, 65862-476-01, 65862-476-05, 65862-476-99, 65862-476-10, 65862-477-30, 65862-477-01, 65862-477-05, 65862-477-99, 65862-477-10, 68001-140-04, 68001-142-00, 68001-142-03, 68001-143-00, 68001-143-03, 68001-141-00, 68001-141-03, 68001-428-00, 68001-429-00, 68001-430-00, 68001-430-03, 68001-431-00, 68001-431-03, 62135-271-01, 62135-271-30, 62135-272-01, 62135-272-05, 62135-273-01, 62135-273-05, 62135-274-01, 62135-274-05, 55111-438-30, 55111-438-60, 55111-438-90, 55111-438-01, 55111-438-05, 55111-438-10, 55111-438-79, 55111-438-78, 55111-439-30, 55111-439-60, 55111-439-90, 55111-439-01, 55111-439-05, 55111-439-10, 55111-439-79, 55111-439-78, 55111-440-30, 55111-440-60, 55111-440-90, 55111-440-01, 55111-440-05, 55111-440-10, 55111-440-79, 55111-440-78, 55111-441-30, 55111-441-60, 55111-441-90, 55111-441-01, 55111-441-05, 55111-441-10, 55111-441-79, 55111-441-78, 52817-270-10, 52817-270-30, 52817-271-10, 52817-271-30,
Patient Weight(kg): 98
Reporter Country: US
Individual Submitting: Pharmacist
Expedited?: Expedited

Patient Reaction: Skin discolouration, Rash,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
SULFASALAZINE. Concomitant drug
RAMIPRIL. Concomitant drug
JAKAFI 25 MG, BID Oral Dose not changed Suspect drug 2013-02-23
PREDNISONE. Concomitant drug
MAG-TAB Concomitant drug
ATORVASTATIN Concomitant drug
BISOPROLOL Concomitant drug
LEVOTHYROXINE Concomitant drug
LORTAB Concomitant drug
ASPIRIN. Concomitant drug

Drug Info:

Generic Name: SULFASALAZINE RAMIPRIL RUXOLITINIB PREDNISONE BISOPROLOL FUMARATE LEVOTHYROXINE HYDROCODONE BITARTRATE AND ACETAMINOPHEN ASPIRIN ASPIRIN 81 MG ASPIRIN 81MG ASPIRIN 325 MG
Pharmacologic Class: Angiotensin Converting Enzyme Inhibitor [EPC]
Application Number: NDA007073 ANDA085828 ANDA077626 ANDA078832 NDA019901 ANDA090697 ANDA077900 ANDA091604 ANDA202392 ANDA078745 ANDA078191 NDA202192 NDA202020 ANDA211496 ANDA080292 ANDA088832 ANDA083677 ANDA040584 ANDA040581 ANDA040256 ANDA040392 ANDA084122 ANDA087342 ANDA080352 ANDA211495 ANDA087800 ANDA087801 ANDA084283 ANDA088703 ANDA210525 ANDA213386 ANDA040362 ANDA211575 ANDA080356 ANDA085162 ANDA085161 ANDA040611 ANDA075474 ANDA040881 part343
Manufacturer Name:
(Google Search)
Pharmacia and Upjohn Company LLC Actavis Pharma, Inc. Greenstone LLC Lupin Pharmaceuticals, Inc. Cadila Healthcare Limited Pfizer Laboratories Div Pfizer Inc Zydus Pharmaceuticals (USA) Inc. West-Ward Pharmaceuticals Corp. Rising Health, LLC Exelan Pharmaceuticals, Inc. Accord Healthcare Inc. Aurobindo Pharma Limited BluePoint Laboratories Chartwell RX, LLC. Dr. Reddy's Laboratories Limited Incyte Corporation Horizon Therapeutics USA, Inc. GeneYork Pharmaceuticals Group LLC Mylan Pharmaceuticals Inc. Par Pharmaceutical Lannett Company, Inc. Hikma Pharmaceuticals USA Inc. West-ward Pharmaceuticals Corp Amneal Pharmaceuticals NY LLC JUBILANT CADISTA PHARMACEUTICALS INC. Novitium Pharma LLC Actavis Pharma, Inc. TruPharma, LLC Deseret Biologicals, Inc. Akorn, Inc. Wal-Mart Stores Inc Unifirst First Aid Corporation Strategic Sourcing Services LLC New Genesis/Monticello Drug LLC Walgreen Company Cardinal Health CHAIN DRUG MARKETING ASSOCIATION INC H E B BJWC Kroger Company Henry Schein, Inc. L.N.K. International, Inc. Care One (American Sales Company) 7-Eleven Moore Medical LLC SPIRIT PHARMACEUTICALS LLC HART Health Bayer HealthCare LLC. Safeway Marc Glassman, Inc. Geritrex LLC Pharmadel LLC Whole Foods Market, INC. DOLGENCORP, LLC The Kroger Co. WR Group, Inc. EQUATE (Wal-Mart Stores, Inc.) Publix Supermarkets, Inc. Rugby Laboratories, Inc Advance Pharmaceutical Inc. Rite Aid Corporation Richmond Pharmaceuticals, Inc. Valu Merchandisers Company Magno-Humphries, Inc. FRED'S, INC. Major Pharmaceuticals Time-Cap Labs, Inc CVS Pharmacy Topco Associates, LLC Allegiant Health Meijer Distribution Inc Genuine First Aid LLC Meijer Paddock Laboratories, LLC Healthy Accents (DZA Brands, LLC) Family Dollar Services Inc Prime Marketing, LLC SUPERVALU INC. Topco Associates LLC COSTCO WHOLESALE CORPORATION Better Living Brands, LLC New World Imports, Inc MAJOR PHARMACEUTICALS Publix Super Markets Inc CARDINAL HEALTH, INC. RETAIL BUSINESS SERVICES , LLC. SMART SENSE (Kmart) FOODHOLD U.S.A., LLC Marlex Pharmaceuticals Inc Chain Drug Consortium GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. AiPing Pharmaceutical, Inc. Geri-Care Pharmaceutical Corp Conney Safety Products, LLC L&R Distributors, Inc. VALU MERCHANDISERS COMPANY Amerisource Bergen Rugby Laboratories RUGBY ARMY AND AIR FORCE EXCHANGE SERVICE America Medic & Science, LLC Harris Teeter Harmon Stores Inc. Harmon Store Inc. America's Pharmacy Source LLC L. Perrigo Company Greenbrier International AAA Pharmaceutical, Inc. Target Corporation Dolgencorp, LLC ADVANCED FIRST AID, INC. Lil' Drug Store Products, Inc. HARRIS TEETER Kmart Corporation Good Sense (Geiss, Destin & Dunn, Inc.) P & L Development, LLC Hy-Vee Chain Drug Marketing Association Wakefern Food Corporation Supervalu Inc. SMART SENSE (KMART) Qualitest Pharmaceutical, Inc. Provision Medical Products United Exchange Corp. United Exchange Corporation Chain Drug Consortium, LLC Afassco Inc. PLD Acquisitions LLC DBA Avma Pharma Solutions AiPing Pharmaceutical Inc. TOP CARE (Topco Associates LLC) TIME CAP LABORATORIES, INC CARDINAL HEALTH Salado Sales, Inc. QUALITY CHOICE (Chain Drug Marketing Association) Rugby Laboratories, Inc. Reliable 1 Laboratories LLC Geri-Care Pharmaceuticals, Corp SAVE-A-LOT FOOD STORES, LTD. Freds Inc GOODSENSE Supervalu Inc Healthlife of USA Cardinal Health (Leader) 70000 EQUALINE (SuperValu) WinCo Foods, LLC Best Choice (Valu Merchandisers Company) Honeywell Safety Products USA, Inc Sam's West Inc Achlis Laboratories Bene Health OTC TARGET Corporation Zee Medical Inc Medtech Products Inc. BJWC (Berkley & Jensen / BJ's) AmerisourceBergen (Good Neighbor Pharmacy) 46122 American Sales Company GREENBRIER INTERNATIONAL, INC. Retail Business Services , LLC. MEIJER, INC. Beacon Pharma, Inc. Acme United Corporation Richmond Pharmaceuticals, Inc PUBLIX SUPER MARKETS INC Discount Drug Mart TopCo Associates LLC TopCare Health Pharma USA LLC Athlete's Needs Inc Bi-Mart Medline Industries Safetec of America, Inc. Dr. Reddy's Laboratories Inc. Prodigy Innovation LLC Family Dollar (FAMILY WELLNESS) TARGET CORPORATION Genvion Corporation Lidl US LLC ASSURED / DOLLAR TREE (Greenbrier International, Inc.) HEB DISCOUNT DRUG MART Foundation Consumer Healthcare Foundation Consumer Healthcare LLC AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 America Medic & Science Lidl USA LLC Raritan Pharmaceuticals Inc ULINE

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Product NDC:
(NLM DailyMed Link)
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