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

Patient Reaction: Back pain, Paraesthesia, Neck pain, Muscle spasms,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
AVONEX Intramuscular Dose not changed Suspect drug MULTIPLE SCLEROSIS 2009-02-17
AVONEX Intramuscular Dose not changed Suspect drug MULTIPLE SCLEROSIS 2014-01-23
AVONEX Intramuscular Dose not changed Suspect drug MULTIPLE SCLEROSIS 2014-01-31
AVONEX Intramuscular Dose not changed Suspect drug MULTIPLE SCLEROSIS 2014-02-07
AVONEX Intramuscular Dose not changed Suspect drug MULTIPLE SCLEROSIS 2014-02-14
COREG Oral Concomitant drug HYPERTENSION 2011-02-01
NORVASC Oral Concomitant drug HYPERTENSION 2011-02-01
AROMACIN Oral Concomitant drug BREAST CANCER 2006-02-01
CLONIPIN Oral Concomitant drug ANXIETY 2013-02-01
XANAX Oral Concomitant drug ANXIETY 2013-02-01
VITAMIN D Oral Concomitant drug VITAMIN D DEFICIENCY 2013-02-01

Drug Info:

Generic Name: INTERFERON BETA-1A INTERFERON BETA-1A INTERFERON BETA-1A INTERFERON BETA-1A INTERFERON BETA-1A CARVEDILOL PHOSPHATE CARVEDILOL AMLODIPINE BESYLATE ALPRAZOLAM ERGOCALCIFEROL
Pharmacologic Class:
Application Number: BLA103628 BLA103628 BLA103628 BLA103628 BLA103628 NDA022012 NDA020297 NDA019787 NDA018276 NDA021434 ANDA090455

SPL ID: 6c9b8e73-7e88-42aa-b23b-a98cf6dccc7b, 6c9b8e73-7e88-42aa-b23b-a98cf6dccc7b, 6c9b8e73-7e88-42aa-b23b-a98cf6dccc7b, 6c9b8e73-7e88-42aa-b23b-a98cf6dccc7b, 6c9b8e73-7e88-42aa-b23b-a98cf6dccc7b, d1eb3353-1a6e-4fa8-ae95-7a3e94ee1da8, 23351329-9cc0-4d49-baaf-41e2a85d020f, 3f5ca9a3-9076-49ab-b247-669c337f3364, d95506a3-aba6-47f4-83c4-443a4cce678b, dfdda989-af0a-4c14-871c-b26b7b6da50e, 08a99dff-5765-49b0-b289-4e854d3c6725,
SPL Set ID: d70a39cc-de15-4c12-a1ec-8063b69ea0e1, d70a39cc-de15-4c12-a1ec-8063b69ea0e1, d70a39cc-de15-4c12-a1ec-8063b69ea0e1, d70a39cc-de15-4c12-a1ec-8063b69ea0e1, d70a39cc-de15-4c12-a1ec-8063b69ea0e1, 06400a4c-42b4-440a-92b4-1f47f98ac7ba, c57982f2-c7da-488a-7ea9-b9609439ac68, abd6a2ca-40c2-485c-bc53-db1c652505ed, aa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239f, 2c4c0a36-12cf-444d-9d57-de983eef4d36,

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

Patient Reaction: Constipation, Flushing, Pruritus,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
TECFIDERA Oral Dose not changed Suspect drug MULTIPLE SCLEROSIS
AMLODIPINE BESY-BENAZEPRIL HCL Concomitant drug
COREG Concomitant drug
LOSARTAN POTASSIUM Concomitant drug
ASPIR-LOW Concomitant drug
TYLENOL Concomitant drug

Drug Info:

Generic Name: DIMETHYL FUMARATE CARVEDILOL PHOSPHATE CARVEDILOL LOSARTAN POTASSIUM ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN
Pharmacologic Class:
Application Number: NDA204063 NDA022012 NDA020297 ANDA078243 ANDA203835 ANDA077459 ANDA078232 ANDA077424 ANDA202230 ANDA091541 NDA020386 ANDA090467 ANDA090428 ANDA090083 ANDA091497 ANDA203030 ANDA090382 ANDA201170 part341 part343

SPL ID: cfad7da3-0e1a-40fa-9b82-f48d790c241b, d1eb3353-1a6e-4fa8-ae95-7a3e94ee1da8, 23351329-9cc0-4d49-baaf-41e2a85d020f, 947c4505-9310-2ba5-e053-2a95a90aa705, 613acc5c-3484-4a02-9a82-24e22853f9dc, ef63ba56-c284-4da0-a2e9-e0ba16442a66, 7d5d5ee2-d6d2-6641-e053-2991aa0aedb7, 910a0c8c-586b-bfd5-e053-2a95a90a20b7, 80d875fa-9b66-4d79-a4eb-11118addce1a, 97f6b559-737d-4def-ba43-0c674c072c7a, fd8306c9-0153-4a75-8318-d47047ff2c96, a4fc53e2-2556-4fcc-b6fb-32a256a2c3f7, f90f53df-b01f-446c-ba07-a67a459163a1, b4569d81-27a1-4b81-ad16-82005587dae1, d5571a70-fe83-4277-ac42-ffaff2e051b2, e852e09d-15b7-4cd6-b0f0-16a0a91d8e89, 60d33fe1-dd2b-419b-a4d0-f104a4da178f, 770618d6-44c5-4840-8d77-d06522edec85, 85bab3eb-5c5d-4250-9349-e73164461cb6, 720575bb-67cf-40a7-a2de-9db9c0095c02, ab9e8877-439e-4522-83a8-82db9e9e3de2, e0b9eaef-95a8-42d5-8970-471d7f52e11f, 3a21e5c5-1d02-4ca6-a15c-43d824167b43, f009b808-5433-452c-9b42-13695cb2deee, 25c041f0-d104-4fb2-8eae-dad611693c22, af09a6cd-aadd-4223-b4c8-d9d4419a0276, 068c419e-d1f7-46d9-bdd0-05aa4039a374, beb748d2-f7b6-4622-b9e7-8c9dabd58d6a, b383bf14-cdd0-4d83-8a38-0fd83b716068, bdd38d39-4437-4c8e-a2d5-4c09b7f4c32c, 698aa1f5-dce5-4507-9d37-60e91f38685f, 8851a351-49b8-430b-9903-3aa2116e267f, e66866f8-143f-40cf-a1c3-1a21781d93d3, 074e51a5-0a78-44ed-8024-33d10e269d9b, e7277c8d-e9fe-4882-9cc2-2cad74ed271e,
SPL Set ID: 665d7e74-036c-5f68-5b67-ab84b9b49151, 06400a4c-42b4-440a-92b4-1f47f98ac7ba, c57982f2-c7da-488a-7ea9-b9609439ac68, 9cb7a81e-06ba-4376-99b4-ccaa9d61a459, a8817f22-8478-49b9-8354-ab27ca222c6b, eeb77c84-38d3-432d-914a-54b312b374bd, f2f2b6c6-0ab1-483f-b4a2-78dfe3200153, 85d69d02-c5ef-467e-94aa-903100218795, 499df918-9c97-4e13-ab56-0bec5d61d652, 8310a858-b9e7-49b3-e053-2991aa0abfa6, 1dadbe02-289c-4312-9e65-40f3314dcc31, 1bf520a2-a50e-a6ae-0fdf-9be4e69729c0, 20421665-0401-4f6e-9e1d-232c654efb0f, d5571a70-fe83-4277-ac42-ffaff2e051b2, cafd54e8-42a8-474c-8ea8-49ec74c2b0d3, 3233c707-70b6-4c29-8210-913eeb2a38ed, db36c4f9-a1b7-48ad-b516-b78b224a5ac5, fa0cf2c2-6238-4edd-94e2-b670b98a0da4, e5886220-43b7-46e1-9034-5242ba245bd1, 31366b4b-dfd6-4fda-babe-2cb3d2c14a2b, 92691768-b5e6-4527-98dc-d86c58f6f13e, 9ccd6823-e813-472c-99cd-c6ef25e74bed, 4c2347db-79a3-4279-87f8-9fa91e6d00e3, 5ac32c20-169d-475a-fc8a-934f758d6ab0, 24477946-63ed-456b-97e8-9d487f365cfa, 1b164780-ec84-4187-8afa-6f8a0da550fc, 1622f694-4d63-4c56-8737-fae31f0ecfb7, dd87e342-b0cb-4111-9f15-415dbcda4b77, bb6533e5-e6a9-488c-b8ab-a6a06e87ede9, 01f41fae-4abb-4b96-ab09-a7d3dfc286cd, de5c6654-56c5-40d3-a286-f04ed47ac7c8, c019e048-167d-466f-896f-84144dd47f7e, 015a6179-bacb-452d-b594-4de628ddc11d, ce43e5c2-fe96-4462-882c-d7479318b33d, 511536b2-6cbd-463e-b2db-6feec474cf6b,

Package NDC:
(NLM DailyMed Link)
64406-006-02, 64406-007-03, 64406-005-01, 0007-4141-20, 0007-3383-13, 0007-4142-20, 0007-3370-13, 0007-3385-13, 0007-3372-13, 0007-3371-13, 0007-3387-13, 0007-4140-20, 0007-3373-61, 0007-4139-20, 0007-3388-13, 0007-3373-13, 65862-202-30, 0054-0123-22, 57237-205-30, 62332-029-30, 62332-029-31, 72865-141-90, 13668-409-30, 43547-362-11, 59746-335-10, 42571-112-30, 0006-0960-31, 13668-115-30, 64380-934-07, 46708-447-31, 46708-447-30, 13668-113-74, 62332-027-90, 62332-027-91, 65841-730-24, 68382-137-16, 59746-335-90, 0781-5701-74, 68382-137-10, 33342-046-07, 42571-110-90, 0781-5701-92, 29300-146-13, 57237-204-90, 13107-195-99, 62332-028-31, 62332-028-30, 29300-146-19, 31722-701-90, 13107-195-90, 76519-1033-9, 76519-1033-8, 46708-446-90, 46708-446-91, 68382-136-24, 76519-1033-1, 76519-1033-3, 76519-1033-2, 65862-203-99, 65862-201-99, 33342-045-10, 65862-203-90, 65862-201-90, 33342-046-10, 33342-046-12, 31722-702-05, 65841-731-10, 31722-702-90, 57237-206-30, 13107-196-30, 33342-044-10, 72865-141-10, 31722-700-60, 33342-044-44, 46708-447-91, 46708-447-90, 29300-146-01, 0781-5700-01, 13668-115-90, 68180-378-03, 31722-701-10, 0781-5702-01, 59746-335-30, 65841-730-01, 13668-113-10, 68382-135-24, 42571-112-10, 72865-143-10, 13668-115-10, 42571-110-10, 0781-5700-10, 68382-137-30, 13668-113-90, 72865-143-90, 65841-730-06, 65841-731-16, 68180-211-01, 62332-027-30, 62332-027-31, 68382-136-01, 65841-729-16, 59746-334-90, 42571-111-10, 0781-5702-10, 65841-731-77, 31722-700-10, 68180-210-09, 62332-028-91, 62332-028-90, 68180-376-09, 31722-702-30, 59746-334-10, 0781-5700-92, 42571-111-90, 33342-044-12, 13668-409-10, 13668-409-74, 33342-045-07, 68180-211-09, 0781-5701-01, 0781-5701-31, 65841-730-10, 46708-445-91, 46708-445-90, 13668-115-74, 13107-195-05, 62332-029-90, 62332-029-91, 65841-731-01, 65862-203-30, 31722-701-60, 65841-731-06, 43547-361-50, 65841-729-24, 0781-5702-92, 42571-112-90, 68180-210-03, 72865-143-30, 33342-045-12, 13107-196-99, 64380-934-08, 33342-044-07, 0781-5701-10, 13107-196-90, 59746-334-01, 65841-729-01, 43547-361-11, 43547-362-03, 42571-110-30, 29300-145-01, 68180-210-06, 57237-205-99, 13107-195-30, 31722-701-30, 68180-210-01, 68180-377-06, 29300-144-13, 29300-144-10, 59746-333-30, 68180-377-03, 13107-197-99, 29300-144-19, 43547-361-03, 13107-197-90, 68180-377-09, 43547-362-50, 0006-0951-54, 72865-142-90, 31722-700-30, 68180-377-01, 46708-445-31, 46708-445-30, 65841-729-10, 57237-204-05, 31722-702-10, 59746-334-30, 72865-142-10, 29300-145-10, 29300-145-13, 68180-378-09, 29300-145-19, 68180-378-06, 29300-144-01, 68180-378-01, 59746-333-01, 68180-211-06, 0006-0952-31, 68180-211-03, 31722-700-05, 68180-376-06, 0054-0124-22, 68180-376-03, 0054-0125-22, 43547-361-09, 29300-146-10, 65841-730-16, 72865-141-30, 0006-0960-54, 57237-205-90, 65862-201-30, 59746-333-90, 65862-202-99, 31722-700-90, 68382-136-10, 65862-202-90, 68382-136-16, 64380-933-06, 64380-933-07, 68180-212-06, 64380-933-05, 31722-702-60, 68180-212-01, 68382-137-77, 68180-212-03, 59746-333-10, 68180-212-09, 64380-933-08, 13668-409-90, 64380-934-06, 64380-934-05, 64380-934-04, 68382-135-06, 64380-935-04, 33342-046-44, 42571-111-30, 65841-729-06, 68382-135-01, 65841-731-30, 43547-360-09, 31722-701-05, 76519-1148-9, 68180-376-01, 64380-935-07, 64380-933-04, 65862-201-05, 43547-362-09, 59746-335-01, 72865-142-30, 64380-935-05, 68382-136-06, 57237-206-99, 57237-204-99, 33342-045-44, 57237-206-90, 46708-446-30, 46708-446-31, 13107-197-30, 68382-137-06, 0781-5702-31, 68382-137-01, 64380-935-06, 0006-0952-54, 64380-935-08, 68382-135-10, 43547-360-50, 43547-360-11, 68382-135-16, 50580-590-06, 50580-590-04, 50580-590-05, 50580-590-02, 50580-590-03, 50580-458-50, 50580-590-01, 50580-451-03, 50580-458-10, 50580-458-11, 50580-412-03, 50580-412-02, 50580-412-01, 50580-488-28, 50580-488-24, 50580-488-25, 50580-495-01, 50580-488-01, 50580-487-20, 50580-566-25, 50580-451-10, 50580-496-60, 50580-451-50, 50580-451-70, 50580-487-90, 50580-496-98, 50580-488-10, 50580-600-02, 50580-600-03, 50580-600-01, 50580-692-01, 50580-488-52, 50580-692-03, 50580-692-02,
Patient Weight(kg): 108
Reporter Country: US
Individual Submitting: Lawyer
Expedited?: Expedited

Patient Reaction: Cardiac arrest, Acute myocardial infarction, Left atrial dilatation, Hyponatraemia, Hypertension, Coronary artery disease, Ischaemic cardiomyopathy, Fatigue, Ventricular tachycardia, Ventricular fibrillation, Heart rate increased, Cardiac failure acute, Atrial fibrillation, Hypogonadism, Respiratory failure, Ejection fraction decreased, Cardiac failure congestive, Sinus bradycardia, Coronary artery occlusion, Sleep apnoea syndrome,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
CRESTOR 40 MG, QD Oral Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2010-10-14
ASPIRIN USA 325 MG, QD Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2010-10-14
IRON UNK, QD Oral Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2011-10-31
NITROSTAT 0.4 MG, PRN Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2013-08-26
ATENOLOL. 25 MG, QD Oral Unknown Suspect drug VENTRICULAR EXTRASYSTOLES 1999-01-18
LASIX UNK, UNKNOWN Intravenous (not otherwise specified) Drug withdrawn Suspect drug CARDIAC FAILURE 2013-07-30
AXIRON 60 MG, QD Topical Dose reduced Suspect drug ANDROGEN DEFICIENCY 2011-10-10
AXIRON 90 MG, QD Topical Dose reduced Suspect drug 2013-06-25
NORPACE 150 MG, QD Unknown Unknown Concomitant drug VENTRICULAR EXTRASYSTOLES 1999-01-18
NIASPAN 150 MG, QD Oral Unknown Concomitant drug HYPERLIPIDAEMIA 2010-10-14
PRADAXA 75 MG, BID Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2011-12-08
PLAVIX 75 MG, QD Oral Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2013-08-26
LASIX UNK, UNKNOWN Oral Drug withdrawn Suspect drug
CIALIS 10 MG, PRN Oral Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2010-10-14
VITAMIN D /00107901/ 5000 IU, 2/W Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2011-10-31
AMIODARONE UNK, UNKNOWN Unknown Unknown Suspect drug VENTRICULAR TACHYCARDIA 2013-07-30
AXIRON 90 MG, WEEKLY (1/W) Topical Dose reduced Suspect drug
ANDROGEL 5 G, QD Topical Drug withdrawn Suspect drug PRODUCT USED FOR UNKNOWN INDICATION 2013-07-25 2013-10-17
ATENOLOL. Unknown Suspect drug PRESYNCOPE
CYMBALTA 60 MG, UNK Oral Unknown Concomitant drug DEPRESSION 2010-10-14
WELLBUTRIN 150 MG, QD Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2010-10-14
SYNTHROID 88 UG, QD Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2010-10-14
MULTAQ 400 MG, BID Oral Unknown Concomitant drug ATRIAL FIBRILLATION 2011-11-22
COREG UNK, BID Unknown Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION 2013-08-26

Drug Info:

Generic Name: ROSUVASTATIN CALCIUM IRON NITROGLYCERIN ATENOLOL FUROSEMIDE DISOPYRAMIDE PHOSPHATE NIACIN DABIGATRAN ETEXILATE MESYLATE CLOPIDOGREL BISULFATE CLOPIDOGREL FUROSEMIDE TADALAFIL TESTOSTERONE ATENOLOL DULOXETINE HYDROCHLORIDE BUPROPION HYDROCHLORIDE LEVOTHYROXINE SODIUM DRONEDARONE CARVEDILOL PHOSPHATE CARVEDILOL
Pharmacologic Class: Antiarrhythmic [EPC]
Application Number: NDA021366 NDA021134 ANDA073457 ANDA076900 ANDA213136 ANDA074056 ANDA074052 ANDA078512 ANDA077443 ANDA073026 ANDA073025 NDA018240 NDA016273 NDA017447 NDA020381 NDA022512 NDA020839 NDA016273 NDA021368 NDA022309 NDA021015 ANDA073457 ANDA076900 ANDA213136 ANDA074056 ANDA074052 ANDA078512 ANDA077443 ANDA073026 ANDA073025 NDA018240 NDA021427 NDA020358 NDA021515 NDA021402 NDA022425 NDA022012 NDA020297

SPL ID: 7805a074-f97c-4e49-ae03-b0101a455477, 859195ed-0b6d-f4fe-e053-2991aa0ad85b, 85912948-19cd-76be-e053-2991aa0a3e5a, 85919b82-39d0-254d-e053-2a91aa0a6150, 6d5e986d-8626-304c-e053-2991aa0aac1c, 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 85914cb4-f904-80c6-e053-2a91aa0ae14a, 85917340-1f95-08db-e053-2a91aa0a77c9, 87372ec7-ead0-90b1-e053-2a91aa0afadf, 9a659c77-f2d9-f1ab-e053-2a95a90a3424, 8591b12c-51c9-9839-e053-2a91aa0aa937, b21bdc0d-86ca-4a5f-9695-a7a8064f5bed, 7e28baf4-a97a-c6ce-3eeb-34c42be47861, bb28a87b-157f-4678-a403-a9c524a6d294, 21664aee-8fe1-468e-a926-f1b320eebce5, 738ed8fd-9ed1-4e58-afb6-a726fa41f62d, 6e0cbb82-3be8-4b45-abe7-b2f542d81bec, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d3cfc587-b084-4771-bbe2-3446e1fe304c, 1e5460cc-8e8d-44cf-b14b-7129a0e95122, 09dd333a-b381-4074-a05a-7cd01fba2413, a2f6ad89-adb0-4846-aa75-c4a07ec3bcae, 4bfbe4c2-0263-415e-9a58-70bfa894ca3b, 7af18caf-1486-6d77-a4e1-8bc200ce5aa7, fdeb89cd-11fc-4393-8fe7-a497e11a9cc8, cb770afe-b6de-469f-9d9c-3db134394d4d, e7450edc-5618-46a4-b431-084919cea917, a2f6ad89-adb0-4846-aa75-c4a07ec3bcae, 5bb8bb3f-c4a8-499b-b9cb-c927576f0578, 98c4655b-0eb4-e920-a954-2143fda23603, c0c3bf6e-8947-d462-10e6-46d36e6865ce, 7e28baf4-a97a-c6ce-3eeb-34c42be47861, bb28a87b-157f-4678-a403-a9c524a6d294, 21664aee-8fe1-468e-a926-f1b320eebce5, 738ed8fd-9ed1-4e58-afb6-a726fa41f62d, 6e0cbb82-3be8-4b45-abe7-b2f542d81bec, 2f8a6d3c-fbcd-4b11-aa14-d0522fa7600e, d3cfc587-b084-4771-bbe2-3446e1fe304c, 1e5460cc-8e8d-44cf-b14b-7129a0e95122, 09dd333a-b381-4074-a05a-7cd01fba2413, d824c2a4-7c1a-4cc3-a2cb-d02cf11de74c, a4bd6e04-f597-4ad4-966d-86cf2efbf5fa, 567c32e3-c563-4556-8e39-7e0f6c7daeb2, db21fc0c-4a2d-9922-39bd-8128e429bebc, 4815ff2b-58c2-44bb-9958-35f1066afb24, d1eb3353-1a6e-4fa8-ae95-7a3e94ee1da8, 23351329-9cc0-4d49-baaf-41e2a85d020f,
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Product NDC:
(NLM DailyMed Link)
0310-0751, 0310-0752, 0310-0754, 0310-0755, 0220-2046, 0220-2055, 0220-2051, 0220-2050, 0220-2047, 0220-2054, 62106-5042, 71919-289, 0220-2085, 68428-383, 0071-0419, 0071-0418, 0071-0417, 0781-1078, 68382-024, 68382-023, 68382-022, 64980-437, 64980-438, 64980-439, 52427-429, 29300-412, 29300-411, 29300-410, 65862-168, 65862-169, 0093-0752, 0093-0753, 0093-0787, 52427-431, 52427-430, 0378-0757, 65841-022, 65841-023, 65841-024, 0781-1506, 0781-1507, 0378-0231, 0378-0218, 65862-170, 30698-066, 30698-067, 30698-060, 0025-2762, 0025-2742, 0025-2752, 0025-2732, 0074-3080, 0074-3079, 0074-3275, 0074-3274, 0074-3265, 0074-3074, 0597-0108, 0597-0360, 0597-0355, 63653-1171, 63653-1332, 0024-1171, 0024-1332, 30698-066, 30698-067, 30698-060, 0002-4464, 0002-4465, 0002-4462, 0002-4463, 0051-8488, 0051-8425, 0051-8462, 0051-8450, 0781-1078, 68382-024, 68382-023, 68382-022, 64980-437, 64980-438, 64980-439, 52427-429, 29300-412, 29300-411, 29300-410, 65862-168, 65862-169, 0093-0752, 0093-0753, 0093-0787, 52427-431, 52427-430, 0378-0757, 65841-022, 65841-023, 65841-024, 0781-1506, 0781-1507, 0378-0231, 0378-0218, 65862-170, 0002-3270, 0002-3235, 0002-3240, 0187-0730, 0187-0731, 0173-0947, 0173-0135, 0173-0722, 0074-4552, 0074-4341, 0074-9296, 0074-7068, 0074-7069, 0074-7148, 0074-7070, 0074-6624, 0074-7149, 0074-6594, 0074-3727, 0074-5182, 0024-4142, 0007-3383, 0007-3388, 0007-4139, 0007-3385, 0007-4140, 0007-4141, 0007-4142, 0007-3371, 0007-3372, 0007-3373, 0007-3387, 0007-3370,
Package NDC:
(NLM DailyMed Link)
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Patient Weight(kg): 66.68
Reporter Country: US
Individual Submitting: Consumer or non-health professional
Expedited?: Expedited

Patient Reaction: Blindness, Deafness, Loss of consciousness, Contusion, Glaucoma, Pruritus, Muscle disorder, Confusional state, Skin lesion, Pain, Oral disorder, Delusion, Aggression,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
XARELTO Oral Drug withdrawn Suspect drug CEREBROVASCULAR ACCIDENT PROPHYLAXIS 2013-08-30 2013-09-04
XARELTO Oral Drug withdrawn Suspect drug ATRIAL FIBRILLATION 2013-08-30 2013-09-04
ASPIRIN Unknown Unknown Suspect drug CARDIAC FAILURE CONGESTIVE
COREG Unknown Concomitant drug CARDIAC FAILURE CONGESTIVE
IMDUR Unknown Concomitant drug
LISINOPRIL Unknown Concomitant drug CARDIAC FAILURE CONGESTIVE
AMARYL Unknown Concomitant drug DIABETES MELLITUS

Drug Info:

Generic Name: RIVAROXABAN RIVAROXABAN ASPIRIN 81MG ASPIRIN 325 MG ASPIRIN 81 MG ASPIRIN CARVEDILOL PHOSPHATE CARVEDILOL LISINOPRIL GLIMEPIRIDE
Pharmacologic Class:
Application Number: NDA022406 NDA202439 NDA022406 NDA202439 part343 NDA022012 NDA020297 ANDA075994 ANDA075743 NDA019777 ANDA076063 ANDA078402 ANDA203508 NDA208401 ANDA076059 ANDA076180 ANDA077321 ANDA077622 ANDA202554 NDA019558 ANDA076164 NDA020496
Manufacturer Name:
(Google Search)
Janssen Pharmaceuticals, Inc. Janssen Pharmaceuticals, Inc. Meijer DOLGENCORP, LLC Paddock Laboratories, LLC Conney Safety Products, LLC America's Pharmacy Source LLC Chain Drug Consortium Shopko Stores Operating Co., LLC. TopCo Associates LLC L.N.K. International, Inc. Lidl US LLC TARGET Corporation Henry Schein, Inc. DZA Brands LLC Chain Drug Marketing Association HART Health Honeywell Safety Products USA, Inc WinCo Foods, LLC Target Corporation The Kroger Co. Pharmadel LLC Harris Teeter Publix Supermarkets, Inc. America Medic & Science Harmon Stores Inc. PLD Acquisitions LLC DBA Avma Pharma Solutions Dr. Reddy's Laboratories Inc. Care One (American Sales Company) Discount Drug Mart Meijer Distribution Inc Acme United Corporation TIME CAP LABORATORIES, INC Zee Medical Inc CHAIN DRUG MARKETING ASSOCIATION INC Harmon Store Inc. Advance Pharmaceutical Inc. Freds Inc L. Perrigo Company Athlete's Needs Inc Kmart Corporation EQUATE (Wal-Mart Stores, Inc.) Major Pharmaceuticals Genvion Corporation Foundation Consumer Healthcare LLC Unifirst First Aid Corporation Achlis Laboratories AmerisourceBergen (Good Neighbor Pharmacy) 46122 Prodigy Innovation LLC Prime Marketing, LLC CVS Pharmacy CARDINAL HEALTH Wal-Mart Stores Inc Family Dollar Services Inc Provision Medical Products P & L Development, LLC America Medic & Science, LLC Marc Glassman, Inc. RUGBY L&R Distributors, Inc. Moore Medical LLC Strategic Sourcing Services LLC WR Group, Inc. Rugby Laboratories, Inc. Chain Drug Consortium, LLC QUALITY CHOICE (Chain Drug Marketing Association) Salado Sales, Inc. Safetec of America, Inc. Magno-Humphries, Inc. Geri-Care Pharmaceuticals, Corp COSTCO WHOLESALE CORPORATION FRED'S, INC. United Exchange Corporation CARDINAL HEALTH, INC. Topco Associates LLC Good Sense (Geiss, Destin & Dunn, Inc.) ARMY AND AIR FORCE EXCHANGE SERVICE Health Pharma USA LLC 7-Eleven SAVE-A-LOT FOOD STORES, LTD. MAJOR PHARMACEUTICALS Cardinal Health (Leader) 70000 AiPing Pharmaceutical, Inc. GOODSENSE Supervalu Inc. American Sales Company Cardinal Health Publix Super Markets Inc Geri-Care Pharmaceutical Corp Medline Industries SMART SENSE (Kmart) Topco Associates, LLC Sam's West Inc Richmond Pharmaceuticals, Inc Walgreen Company Lil' Drug Store Products, Inc. New World Imports, Inc Greenbrier International Best Choice (Valu Merchandisers Company) AiPing Pharmaceutical Inc. ADVANCED FIRST AID, INC. Rugby Laboratories Safeway Retail Business Services , LLC. HEB Bayer HealthCare LLC. Genuine First Aid LLC BJWC ASSURED / DOLLAR TREE (Greenbrier International, Inc.) Qualitest Pharmaceutical, Inc. Raritan Pharmaceuticals Inc Dolgencorp, LLC GREENBRIER INTERNATIONAL, INC. Valu Merchandisers Company Rite Aid Corporation MEIJER, INC. SMART SENSE (KMART) EQUALINE (SuperValu) Whole Foods Market, INC. ULINE Geritrex LLC Reliable 1 Laboratories LLC Family Dollar (FAMILY WELLNESS) AAA Pharmaceutical, Inc. United Exchange Corp. Afassco Inc. Bene Health OTC Lidl USA LLC FOODHOLD U.S.A., LLC Medtech Products Inc. Hy-Vee AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 HARRIS TEETER Marlex Pharmaceuticals Inc BJWC (Berkley & Jensen / BJ's) Beacon Pharma, Inc. H E B Bi-Mart Rugby Laboratories, Inc Kroger Company Amerisource Bergen GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. TOP CARE (Topco Associates LLC) New Genesis/Monticello Drug LLC Healthy Accents (DZA Brands, LLC) Richmond Pharmaceuticals, Inc. Allegiant Health Wakefern Food Corporation TARGET CORPORATION Foundation Consumer Healthcare Better Living Brands, LLC SPIRIT PHARMACEUTICALS LLC Supervalu Inc Healthlife of USA TopCare Time-Cap Labs, Inc SUPERVALU INC. GlaxoSmithKline LLC Accord Healthcare Inc. Almatica Pharma Inc. Lupin Pharmaceuticals, Inc. Actavis Pharma, Inc. Solco healthcare U.S., LLC Merck Sharp & Dohme Corp. Azurity Pharmaceuticals, Inc. Wockhardt USA LLC. Eon Labs, Inc. International Laboratories, LLC Hikma Pharmaceuticals USA Inc. Exelan Pharmaceuticals Inc. Aurobindo Pharma Limited BluePoint Laboratories Sanofi-Aventis U.S. LLC

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

Patient Reaction: Haemorrhage, Drug interaction,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
DRONEDARONE Unknown Unknown Suspect drug PRODUCT USED FOR UNKNOWN INDICATION
DABIGATRAN Unknown Unknown Interacting drug PRODUCT USED FOR UNKNOWN INDICATION
NORVASC Concomitant drug
OMEPRAZOLE Concomitant drug
TRAZODONE HYDROCHLORIDE Concomitant drug
CARVEDILOL Concomitant drug
LORAZEPAM Concomitant drug
HYDRALAZINE Concomitant drug
LOVASTATIN Concomitant drug

Drug Info:

Generic Name: DRONEDARONE AMLODIPINE BESYLATE OMEPRAZOLE MAGNESIUM OMEPRAZOLE TRAZODONE HYDROCHLORIDE CARVEDILOL LORAZEPAM HYDRALAZINE HYDROCHLORIDE LOVASTATIN
Pharmacologic Class: Antiarrhythmic [EPC]
Application Number: NDA022425 NDA019787 ANDA206877 ANDA078878 ANDA207740 ANDA207891 ANDA076515 ANDA206582 NDA209400 ANDA203270 ANDA078490 ANDA203481 NDA022032 ANDA091352 ANDA076048 ANDA075410 ANDA210593 ANDA204012 ANDA075576 ANDA091672 ANDA075757 ANDA204852 ANDA202180 ANDA206923 ANDA071258 ANDA071523 ANDA073137 ANDA071525 ANDA071524 ANDA072193 ANDA072192 ANDA205253 ANDA071196 ANDA078227 ANDA078384 ANDA078251 ANDA077316 ANDA078332 ANDA076649 ANDA077614 NDA020297 ANDA076373 ANDA074282 NDA017794 ANDA074243 ANDA072926 NDA018140 ANDA072927 ANDA072928 ANDA078203 ANDA071141 ANDA075025 ANDA200169 ANDA203572 ANDA090260 ANDA091383 ANDA072755 ANDA076150 ANDA203845 NDA021316 ANDA078296 ANDA075636 ANDA075828 ANDA075551 ANDA075991
Manufacturer Name:
(Google Search)
sanofi-aventis U.S. LLC Pfizer Laboratories Div Pfizer Inc Meijer Distribution Inc Costco Wholesale Company Aldi Inc Glenmark Pharmaceuticals Inc., USA 7-Eleven Cadila Healthcare Limited Shopko Stores Operating Co., LLC American Sales Company Thirty Madison Inc Camber Pharmaceuticals, Inc. Lannett Company, Inc. Fred's, Inc. CVS Pharmacy Aurobindo Pharma Limited Winco Foods, LLC. Wal-Mart Stores Inc Genomma Lab USA, Inc. Apotex Corp Zydus Pharmaceuticals (USA) Inc. P & L Development, LLC NorthStar Rx LLC Rising Health, LLC Family Dollar, Inc. H E B Bi-Mart Humana Pharmacy, Inc. DISCOUNT DRUG MART Sam's West Inc Kroger Company Walgreen Company Breckenridge Pharmaceutical, Inc. Amerisource Bergen Cardinal Health Best Choice Sandoz Inc Publix Super Markets Inc Harmon Stores Inc. Lidl US LLC Supervalu Inc Safeway Ohm Laboratories Inc. Perrigo New York Inc Aurohealth LLC Family Dollar Services Inc Gericare Pharmaceuticals Chain Drug Consortium, LLC Dr. Reddys Laboratories Inc BJWC BluePoint Laboratories THE KROGER COMPANY Army & Air Force Exchange Service Dolgencorp, LLC Dr. Reddy's Laboratories Limited Rite Aid Corporation Strategic Sourcing Services LLC L. Perrigo Company Big Lots Stores, Inc. OHM LABORATORIES INC. Wal-Mart Stores, Inc. Topco Associates LLC Sun Pharmaceutical Industries, Inc. Major Pharmaceuticals GERICARE PHARMACEUTICALS Target Corporation Harris Teeter, LLC Reliable 1 Laboratories LLC Save-A-Lot Food Stores Ltd Torrent Pharmaceuticals Limited Apotex Corp Teva Pharmaceuticals USA, Inc. Zydus Pharmaceuticals (USA) Inc. Par Pharmaceutical Accord Healthcare, Inc. Aurolife Pharma, LLC Sun Pharmaceutical Industries, Inc. Cadila Healthcare Limited GlaxoSmithKline LLC Teva Pharmaceuticals USA, Inc. Marlex Pharmaceuticals Inc Glenmark Pharmaceuticals Inc., USA Zydus Pharmaceuticals (USA) Inc. Dr. Reddy's Laboratories Limited Sandoz Inc Mylan Pharmaceuticals Inc. Solco Healthcare US LLC Cadila Healthcare Limited ACETRIS HEALTH, LLC Bayshore Pharmaceuticals LLC Aurobindo Pharma Limited BluePoint Laboratories Amneal Pharmaceuticals LLC Akorn, Inc. Hi-Tech Pharmacal Co., Inc. West-Ward Pharmaceuticals Corp. Hospira, Inc. Pharmaceutical Associates, Inc. International Medication Systems, Limited Sandoz Inc Bausch Health US LLC Aurolife Pharma, LLC Actavis Pharma, Inc. Leading Pharma, LLC Nivagen Pharmaceuticals, Inc. Covis Pharma Teva Pharmaceuticals USA, Inc. Lupin Pharmaceuticals, Inc. Carlsbad Technology, Inc. Eon Labs, Inc. International Laboratories, LLC Actavis Pharma, Inc. BluePoint Laboratories

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

Patient Reaction: Death,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
REVLIMID 5 MILLIGRAM Oral Suspect drug PLASMA CELL MYELOMA 2013-01-29
ATORVASTATIN CALCIUM Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
CARVEDILOL Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
HYOSCYAMINE SULFATE Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
LEVOTHYROXINE SODIUM Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
LISINOPRIL Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
NOVOLOG Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
PROPRANOLOL HCL Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION
SYNTHROID Unknown Concomitant drug PRODUCT USED FOR UNKNOWN INDICATION

Drug Info:

Generic Name: LENALIDOMIDE ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM, FILM COATED CARVEDILOL HYOSCYAMINE SULFATE LEVOTHYROXINE SODIUM ANHYDROUS LEVOTHYROXINE SODIUM LISINOPRIL INSULIN ASPART LEVOTHYROXINE SODIUM
Pharmacologic Class:
Application Number: NDA021880 ANDA090548 ANDA209912 ANDA091650 ANDA091226 ANDA202357 ANDA091624 ANDA207687 ANDA204991 ANDA206536 ANDA077575 ANDA205519 ANDA205300 NDA020702 ANDA076477 ANDA205945 ANDA209288 ANDA211933 ANDA078227 ANDA078384 ANDA078251 ANDA077316 ANDA078332 ANDA076649 ANDA077614 NDA020297 ANDA076373 NDA202231 NDA021924 NDA021292 NDA021301 ANDA209713 NDA021342 NDA021210 NDA210632 NDA021116 ANDA076187 ANDA208749 NDA021402 NDA206977 ANDA075994 ANDA075743 NDA019777 ANDA076063 ANDA078402 ANDA203508 NDA208401 ANDA076059 ANDA076180 ANDA077321 ANDA077622 ANDA202554 NDA019558 ANDA076164 BLA020986 NDA021402
Manufacturer Name:
(Google Search)
Celgene Corporation Graviti Pharmaceuticals Private Limited Biocon Pharma Inc., MSN LABORATORIES PRIVATE LIMITED Lupin Pharmaceuticals, Inc. Lannett Company, Inc. International Laboratories, LLC Sun Pharmaceutical Industries Inc. Parke-Davis Div of Pfizer Inc Zydus Pharmaceuticals (USA) Inc. Micro Labs Limited ScieGen Pharmaceuticals, Inc. Mylan Pharmaceuticals Inc. Ascend Laboratories, LLC Cipla USA Inc., Novadoz Pharmaceuticals LLC Greenstone LLC Cadila Healthcare Limited Teva Pharmaceuticals USA, Inc. Northstar Rx LLC. Dr. Reddy's Laboratories Limited Apotex Corp. Sandoz Inc Accord Healthcare Inc. GlaxoSmithKline LLC Teva Pharmaceuticals USA, Inc. Marlex Pharmaceuticals Inc Glenmark Pharmaceuticals Inc., USA Zydus Pharmaceuticals (USA) Inc. Dr. Reddy's Laboratories Limited Sandoz Inc Mylan Pharmaceuticals Inc. Solco Healthcare US LLC Cadila Healthcare Limited ACETRIS HEALTH, LLC Bayshore Pharmaceuticals LLC Aurobindo Pharma Limited BluePoint Laboratories Larken Laboratories, Inc. BPI Labs LLC Virtus Pharmaceuticals Patrin Pharma Vilvet Pharmaceuticals Inc Method Pharmaceuticals, LLC Alaven Pharmaceutical LLC Acella Pharmaceuticals, LLC EDWARDS PHARMACEUTICALS, INC. BF ASCHER AND CO INC Lannett Company, Inc. Meda Pharmaceuticals Wallace Pharmaceuticals Inc. Noble Pharmaceuticals, LLC Capellon Pharmaceuticals, LLC County Line Pharmaceuticals, LLC Amneal Pharmaceuticals LLC Provell Pharmaceuticals, LLC Par Pharmaceutical Inc. Athenex Pharmaceutical Division, LLC. Pfizer Laboratories Div Pfizer Inc Alvogen, Inc. Fresenius Kabi USA, LLC Mylan Pharmaceuticals Inc. AbbVie Inc. Lupin Pharmaceuticals, Inc. Sandoz Inc. Lannett Company, Inc. Amneal Pharmaceuticals NY LLC Piramal Critical Care, Inc. IBSA Pharma Inc. Neolpharma, Inc. MAIA Pharmaceuticals, Inc. Accord Healthcare Inc. Almatica Pharma Inc. Lupin Pharmaceuticals, Inc. Actavis Pharma, Inc. Solco healthcare U.S., LLC Merck Sharp & Dohme Corp. Azurity Pharmaceuticals, Inc. Wockhardt USA LLC. Eon Labs, Inc. International Laboratories, LLC Hikma Pharmaceuticals USA Inc. Exelan Pharmaceuticals Inc. Aurobindo Pharma Limited BluePoint Laboratories Novo Nordisk AbbVie Inc.

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Product NDC:
(NLM DailyMed Link)
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RxNorm Code:
(MedlinePlus Connect Link)
643712, 643714, 1429367, 643720, 643722, 1242231, 1242233, 1428947, 602910, 616114, 602912, 616116, 259255, 617318, 262095, 617310, 617311, 617312, 617314, 617320, 212388, 212389, 200031, 200033, 200032, 686924, 686926, 212390, 1242705, 1047895, 1047905, 1047881, 1046984, 1046771, 1149364, 1047908, 1652363, 1046985, 1047918, 1048056, 1046775, 1046770, 1046982, 1048058, 1149355, 1807887, 1807886, 1047907, 1047916, 905451, 905453, 905455, 905457, 905458, 966184, 966401, 966405, 966404, 966407, 966406, 966175, 1923047, 966177, 966170, 966173, 966270, 966178, 1923049, 905464, 905460, 905462, 966434, 966436, 2056496, 966423, 966420, 966426, 966399, 966253, 966397, 2056498, 966157, 2056494, 966154, 966153, 2056490, 2056492, 2056476, 2056474, 2056472, 2056470, 2056478, 966243, 966241, 966246, 966244, 966249, 966248, 2056488, 2056482, 2056480, 2056486, 2056484, 2056466, 2056508, 2056462, 2056502, 2056500, 2056468, 2056506, 2056504, 2166193, 2166196, 966237, 966235, 966232, 966233, 966238, 1115267, 1115269, 966188, 2056510, 966187, 966182, 966225, 966224, 966221, 966220, 966222, 966228, 892255, 892251, 1923050, 1923052, 2166148, 966190, 966197, 966196, 966194, 966211, 966214, 2104866, 966219, 892246, 966208, 966286, 966283, 966412, 966413, 966410, 966417, 966415, 966166, 966167, 966164, 966160, 966161, 966207, 966204, 966202, 966200, 104377, 197884, 104375, 206771, 206765, 104376, 314077, 213482, 206764, 104378, 205326, 314076, 311353, 311354, 206766,
Package NDC:
(NLM DailyMed Link)
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Patient Weight(kg):
Reporter Country: US
Individual Submitting: Other health professional
Expedited?: Expedited

Patient Reaction: Gastrointestinal haemorrhage, Drug interaction, Small intestinal haemorrhage, Gastric haemorrhage,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
DRONEDARONE Unknown Unknown Suspect drug PRODUCT USED FOR UNKNOWN INDICATION
DABIGATRAN Unknown Unknown Interacting drug PRODUCT USED FOR UNKNOWN INDICATION
BENAZEPRIL HYDROCHLORIDE Concomitant drug
AMLODIPINE Concomitant drug
FOLIC ACID Concomitant drug
SYNTHROID Concomitant drug
CARVEDILOL Concomitant drug
SIMVASTATIN Concomitant drug
DEXILANT Concomitant drug
VITAMIN D Concomitant drug

Drug Info:

Generic Name: DRONEDARONE BENAZEPRIL HYDROCHLORIDE AMLODIPINE FOLIC ACID LEVOTHYROXINE SODIUM CARVEDILOL SIMVASTATIN DEXLANSOPRAZOLE ERGOCALCIFEROL
Pharmacologic Class: Antiarrhythmic [EPC]
Application Number: NDA022425 ANDA076118 ANDA076402 ANDA076820 ANDA076430 ANDA078848 NDA019851 ANDA078212 ANDA201380 NDA211340 ANDA040756 ANDA204418 ANDA090035 ANDA202437 ANDA089202 ANDA040796 ANDA202522 ANDA040625 ANDA091145 NDA021402 ANDA078227 ANDA078384 ANDA078251 ANDA077316 ANDA078332 ANDA076649 ANDA077614 NDA020297 ANDA076373 ANDA078155 ANDA078034 ANDA078425 NDA019766 ANDA077691 ANDA090383 ANDA077752 ANDA200895 ANDA077837 ANDA078103 ANDA076052 NDA206679 ANDA206557 NDA022287 ANDA090455
Manufacturer Name:
(Google Search)
sanofi-aventis U.S. LLC Amneal Pharmaceuticals LLC Zydus Pharmaceuticals (USA) Inc. Validus Pharmaceuticals LLC Solco healthcare U.S., LLC Mylan Pharmaceuticals Inc. Aurobindo Pharma Limited Eon Labs, Inc. International Laboratories, LLC Cadila Healthcare Limited Macleods Pharmaceuticals Limited Silvergate Pharmaceuticals, Inc. Amneal Pharmaceuticals LLC Cadila Pharmaceuticals Limited Marlex Pharmaceuticals Inc X-GEN Pharmaceuticals, Inc. Method Pharmaceuticals, LLC Fresenius Kabi USA, LLC Chartwell RX LLC SUNRISE PHARMACEUTICAL, INC. AiPing Pharmaceutical, Inc. Par Pharmaceutical Leading Pharma, LLC AbbVie Inc. GlaxoSmithKline LLC Teva Pharmaceuticals USA, Inc. Marlex Pharmaceuticals Inc Glenmark Pharmaceuticals Inc., USA Zydus Pharmaceuticals (USA) Inc. Dr. Reddy's Laboratories Limited Sandoz Inc Mylan Pharmaceuticals Inc. Solco Healthcare US LLC Cadila Healthcare Limited ACETRIS HEALTH, LLC Bayshore Pharmaceuticals LLC Aurobindo Pharma Limited BluePoint Laboratories Teva Pharmaceuticals USA, Inc. Dr. Reddy's Laboratories Limited ACETRIS HEALTH, LLC Accord Healthcare, Inc. Biocon Pharma Inc, NorthStar Rx LLC Micro Labs Limited Merck Sharp & Dohme Corp. Lupin Pharmaceuticals, Inc. Hisun Pharmaceuticals USA, Inc. Aurobindo Pharma Limited Zydus Pharmaceuticals (USA) Inc. Camber Pharmaceuticals, Inc. International Laboratories, LLC Salerno Pharmaceuticals Co. Cadila Healthcare Limited Takeda Pharmaceuticals America, Inc. Strides Pharma Science Limited

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Product NDC:
(NLM DailyMed Link)
0024-4142, 65862-118, 70771-1150, 70771-1151, 0185-0820, 65862-117, 65862-116, 0185-0048, 0378-0441, 30698-450, 68382-169, 30698-448, 68382-171, 68382-170, 68382-172, 70771-1149, 70771-1148, 0185-0053, 54458-863, 43547-337, 43547-336, 43547-335, 0378-0443, 43547-338, 0378-0447, 0378-0444, 0185-0505, 54458-862, 30698-449, 65162-752, 65162-753, 65162-751, 65162-754, 33342-016, 33342-015, 52652-5001, 71209-007, 63323-184, 10135-182, 65162-361, 69315-127, 11534-165, 11788-001, 0603-3162, 39822-1100, 62135-210, 58657-150, 0074-4552, 0074-4341, 0074-9296, 0074-7068, 0074-7069, 0074-7148, 0074-7070, 0074-6624, 0074-7149, 0074-6594, 0074-3727, 0074-5182, 55111-252, 55111-253, 52343-026, 55111-254, 55111-255, 0781-5224, 76385-110, 0781-5221, 0093-0051, 0781-5222, 76385-113, 76385-112, 76385-111, 0093-7295, 10135-635, 10135-634, 10135-637, 52343-028, 0093-7296, 10135-633, 68462-163, 0378-3631, 0378-3632, 0378-3633, 0007-4139, 68462-165, 68462-164, 68001-153, 68001-152, 68001-151, 68001-154, 68382-092, 68382-093, 68382-094, 68382-095, 65862-144, 65862-145, 65862-142, 65862-143, 68462-162, 43547-254, 43547-255, 43547-256, 43547-257, 0781-5223, 52343-029, 0378-3634, 52343-027, 0007-4140, 0007-4141, 0007-4142, 65841-617, 65841-616, 0093-0135, 65841-619, 65841-618, 54458-934, 0093-7153, 31722-511, 55111-199, 16729-005, 16729-004, 16729-007, 16729-006, 0093-7152, 31722-514, 42658-109, 52343-023, 52343-022, 52343-021, 68180-464, 52343-025, 52343-024, 42571-040, 0093-7156, 70377-004, 70377-005, 16714-685, 16714-684, 16714-683, 16714-682, 16714-681, 68180-482, 55111-197, 54458-933, 68382-068, 65841-065, 29273-402, 29273-401, 68382-067, 16729-156, 0093-7155, 65862-050, 65862-051, 54458-932, 65841-067, 65862-054, 55111-200, 0006-0735, 68180-478, 68180-479, 55111-198, 31722-513, 42658-111, 55111-268, 65841-068, 65841-069, 42658-110, 0093-7154, 70377-001, 68180-481, 42571-010, 65841-066, 68180-480, 42571-080, 65862-052, 65862-053, 70377-002, 31722-512, 0006-0543, 70377-003, 42658-108, 68180-465, 42571-005, 68382-069, 31722-510, 0006-0740, 0006-0726, 0006-0749, 68382-066, 68382-065, 42571-020, 64764-175, 64764-171, 64380-737,
Package NDC:
(NLM DailyMed Link)
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68382-067-10, 68180-464-09, 65841-068-10, 64764-171-11, 64764-171-03, 64764-171-00, 64764-171-01, 64764-171-19, 64764-171-30, 64764-175-11, 64764-175-02, 64764-171-90, 64764-175-00, 64764-175-01, 64764-175-19, 64764-175-90, 64764-175-30, 64380-737-25, 64380-737-06,
Patient Weight(kg):
Reporter Country: US
Individual Submitting: Other health professional
Expedited?: Expedited

Patient Reaction: Gastrointestinal haemorrhage, Drug interaction,

Medications:

Name
(MedlinePlus Link)
Dosage Route Action Characterization Indication
(ClinicalTrials.Gov Link)
Start End
DRONEDARONE Unknown Unknown Suspect drug PRODUCT USED FOR UNKNOWN INDICATION
DABIGATRAN Unknown Unknown Interacting drug PRODUCT USED FOR UNKNOWN INDICATION
FUROSEMIDE Concomitant drug
SIMVASTATIN Concomitant drug
LISINOPRIL Concomitant drug
CARVEDILOL Concomitant drug

Drug Info:

Generic Name: DRONEDARONE FUROSEMIDE SIMVASTATIN LISINOPRIL CARVEDILOL
Pharmacologic Class: Antiarrhythmic [EPC]
Application Number: NDA022425 ANDA070434 ANDA070082 ANDA202747 NDA018823 ANDA212174 NDA018667 ANDA207552 NDA016273 ANDA070655 NDA018902 ANDA077941 ANDA213902 ANDA075241 ANDA070433 NDA018487 NDA018569 ANDA070086 ANDA076796 ANDA077293 ANDA203428 ANDA078155 ANDA078034 ANDA078425 NDA019766 ANDA077691 ANDA090383 ANDA077752 ANDA200895 ANDA077837 ANDA078103 ANDA076052 NDA206679 ANDA206557 ANDA075994 ANDA075743 NDA019777 ANDA076063 ANDA078402 ANDA203508 NDA208401 ANDA076059 ANDA076180 ANDA077321 ANDA077622 ANDA202554 NDA019558 ANDA076164 ANDA078227 ANDA078384 ANDA078251 ANDA077316 ANDA078332 ANDA076649 ANDA077614 NDA020297 ANDA076373
Manufacturer Name:
(Google Search)
sanofi-aventis U.S. LLC Amneal Pharmaceuticals LLC AuroMedics Pharma LLC Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. Solco Healthcare LLC Validus Pharmaceuticals LLC West-Ward Pharmaceuticals Corp. Fresenius Kabi USA, LLC Gland Pharma Limited Hospira, Inc. IT3 Medical LLC Wockhardt USA LLC. Sandoz Inc Morton Grove Pharmaceuticals, Inc. Mylan Pharmaceuticals Inc. Baxter Healthcare Corporation Leading Pharma, LLC Teva Pharmaceuticals USA, Inc. Dr. Reddy's Laboratories Limited ACETRIS HEALTH, LLC Accord Healthcare, Inc. Biocon Pharma Inc, NorthStar Rx LLC Micro Labs Limited Merck Sharp & Dohme Corp. Lupin Pharmaceuticals, Inc. Hisun Pharmaceuticals USA, Inc. Aurobindo Pharma Limited Zydus Pharmaceuticals (USA) Inc. Camber Pharmaceuticals, Inc. International Laboratories, LLC Salerno Pharmaceuticals Co. Cadila Healthcare Limited Accord Healthcare Inc. Almatica Pharma Inc. Lupin Pharmaceuticals, Inc. Actavis Pharma, Inc. Solco healthcare U.S., LLC Merck Sharp & Dohme Corp. Azurity Pharmaceuticals, Inc. Wockhardt USA LLC. Eon Labs, Inc. International Laboratories, LLC Hikma Pharmaceuticals USA Inc. Exelan Pharmaceuticals Inc. Aurobindo Pharma Limited BluePoint Laboratories GlaxoSmithKline LLC Teva Pharmaceuticals USA, Inc. Marlex Pharmaceuticals Inc Glenmark Pharmaceuticals Inc., USA Zydus Pharmaceuticals (USA) Inc. Dr. Reddy's Laboratories Limited Sandoz Inc Mylan Pharmaceuticals Inc. Solco Healthcare US LLC Cadila Healthcare Limited ACETRIS HEALTH, LLC Bayshore Pharmaceuticals LLC Aurobindo Pharma Limited BluePoint Laboratories

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SPL Set ID: 7fa41601-7fb5-4155-8e50-2ae903f0d2d6, 6a0fb397-63ae-4fce-bddf-16a91b1b7a2f, 39fd32f2-6bb7-4a65-d298-e48d26bc80c7, 30cd95a8-ee0d-413d-b26a-6f042e8e1892, c71371a7-75c5-45b8-b762-8d782d4c71bc, 1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec, aaced7a8-c3d7-4d66-8c07-aa407b8b3f35, 3747bbcd-783d-4baa-bb5b-b6827bf390e3, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 2c9b4d8f-0770-482d-a9e6-9c616a440b1a, 99e3dc3c-5416-4bf4-a410-a036f7008294, a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, b39ad6b3-401d-4aba-a0a9-6d56fcfa0ac9, 5c50b5a3-9b39-4cad-8be5-c2a8dd3f7df5, b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe, 34d7b9da-327d-45a7-a87a-f8b6d5e80a7b, 59b21dbe-30a0-405b-b39e-c19cea7ad9d6, 9e493331-dddd-496e-abf8-61747fb67aba, 87960726-e901-4596-bd33-ead02cb93a20, 421aa6d5-623b-4dc2-abd5-bb9e7765bf37, c794c95a-654e-48fe-9596-201fc122ff75, 644704c0-e6a5-4804-bfa6-795c8f83aa7a, 3e48217f-8175-4e9b-9fd0-909be4bbba95, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 1c5178c9-270f-4a5b-a52b-68a56972f035, d9a1a7c5-d806-4dbd-a201-5e73790d078b, 9a3d815e-ab40-4c1c-a065-281dac6685a6, 881eb80b-712e-4aa2-bd23-290a3e5db6cd, 7b325108-6940-50a7-96b4-822a5206e568, 30fbaf9e-01cf-492a-b44f-dc81c17d7647, 751b79c6-bba8-4d29-b69c-a2ac6453fec8, 5c1c694c-4b08-469e-b538-08e69df06146, 2cc2e27d-00d0-4398-9cc6-dafa63ea1ba1, 0376351b-f1a0-43e5-a0b4-533072c49f39, 4724dbb4-3613-4e6a-948f-a43d34f97f06, 6ee17d10-6eb1-452a-99e8-02381368b3fe, fdbfe194-b845-42c5-bb87-a48118bc72e7, 6a365728-e31a-428f-9718-d1a34d686186, 43e2c8d1-3704-4323-bcaf-f582572b81f7, a95727ae-2bf1-e675-4a36-71043a8af3b8, f8d16c85-50e2-4d99-afae-6fb902734e42, d45181e7-0eb8-48e3-bbfe-a922b4204e49, 0e6364a4-6d66-4151-8197-d45e2a762895, 9c52ca06-463b-479f-ad14-48f3d57fea14, 34ebeea1-6812-4697-84c4-b2ae4f39e55f, e927801e-5de4-44f9-b543-789c093de655, b70933da-55b2-4025-a00e-63ce3e6b7fdf, 5e3a6976-e6d6-4a3d-87bb-2c716de23506, e299d477-a612-4af4-b6aa-f5addc8a736d, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 7d6c31e2-b5a4-4279-8013-a8dad37ea73b, 1bc69836-a659-4e3b-84a7-a00b7c4dc268, f6f3c339-2c9d-4d07-14a1-6d6c7daf26c6, 9f6e4e57-a489-4b36-b093-b93865d3717c, 106ff38f-526a-4993-9779-8399e8a0f765, da8b8c20-0130-4aa9-924d-4a4f28c3f767, dc6a2d33-aa04-4a04-9cde-901b744d24ca, 7cc14b86-0833-4c3c-91f3-7963d7052fd5, 1e453c21-a8a8-dc54-5591-74c972d41727, 2ba6d893-ae2a-4535-b904-667d206f93af, e5026c19-733f-41a4-a0c9-e48a9a742460, b0d55eaa-7869-4d07-a92a-85ea0c598462, c57982f2-c7da-488a-7ea9-b9609439ac68, e68c9b18-e7fd-45f7-a8f5-1d815e32680b, 29082d8c-bbde-4620-924f-02dcf1764919, c4a21f67-7812-4634-beba-f8e85c63c5f2, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, 68c275e8-992a-4520-8065-ab6d615d89cc,

Product NDC:
(NLM DailyMed Link)
0024-4142, 36000-065, 36000-064, 68083-434, 0054-4297, 68083-432, 0409-1639, 36000-063, 0378-0216, 70121-1076, 0054-4299, 0781-1818, 0054-8299, 63323-280, 69315-116, 69315-117, 69315-118, 70529-061, 0054-8297, 30698-066, 30698-067, 23155-473, 0409-9631, 70529-062, 70529-549, 60432-613, 70121-1163, 70121-1164, 0781-1966, 0054-3294, 36000-284, 0054-4301, 36000-283, 36000-282, 0409-6102, 0781-1446, 0054-3298, 64679-759, 55150-323, 55150-322, 0378-0232, 55150-324, 43547-401, 0378-0208, 43547-403, 43547-402, 70529-550, 30698-060, 0054-8301, 68083-433, 54458-934, 0093-7153, 31722-511, 55111-199, 16729-005, 16729-004, 16729-007, 16729-006, 0093-7152, 31722-514, 42658-109, 52343-023, 52343-022, 52343-021, 68180-464, 52343-025, 52343-024, 42571-040, 0093-7156, 70377-004, 70377-005, 16714-685, 16714-684, 16714-683, 16714-682, 16714-681, 68180-482, 55111-197, 54458-933, 68382-068, 65841-065, 29273-402, 29273-401, 68382-067, 16729-156, 0093-7155, 65862-050, 65862-051, 54458-932, 65841-067, 65862-054, 55111-200, 0006-0735, 68180-478, 68180-479, 55111-198, 31722-513, 42658-111, 55111-268, 65841-068, 65841-069, 42658-110, 0093-7154, 70377-001, 68180-481, 42571-010, 65841-066, 68180-480, 42571-080, 65862-052, 65862-053, 70377-002, 31722-512, 0006-0543, 70377-003, 42658-108, 68180-465, 42571-005, 68382-069, 31722-510, 0006-0740, 0006-0726, 0006-0749, 68382-066, 68382-065, 42571-020, 52427-441, 68001-337, 68001-336, 68001-335, 68001-334, 68001-333, 68001-332, 0185-0025, 65862-040, 16729-380, 65862-038, 65862-039, 65862-037, 68180-513, 68180-512, 68180-517, 68180-516, 68180-515, 68180-514, 68180-980, 68180-981, 68180-982, 43547-351, 43547-353, 43547-352, 43547-355, 43547-354, 52652-3001, 43547-356, 0143-9713, 0143-9715, 0143-9714, 76282-417, 76282-418, 76282-419, 0185-0605,