Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126529491 | 12652949 | 1 | I | 2012 | 20150820 | 20160815 | 20160815 | PER | US-AMNEAL PHARMACEUTICALS-2016AMN00395 | AMNEAL | 0.00 | F | Y | 71.20000 | KG | 20160815 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126529491 | 12652949 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | 76003 | TABLET | |||||||||||
| 126529491 | 12652949 | 2 | C | FREE STYLE TEST STRIPS | 2 | 0 | |||||||||||||
| 126529491 | 12652949 | 3 | C | INSULIN | INSULIN NOS | 1 | UNK, 4X/DAY | 0 | QID | ||||||||||
| 126529491 | 12652949 | 4 | C | METOLAZONE. | METOLAZONE | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 126529491 | 12652949 | 5 | C | BUMETANIDE. | BUMETANIDE | 1 | 1 MG, 1X/DAY | 0 | 1 | MG | QD | ||||||||
| 126529491 | 12652949 | 6 | C | NOVOLOG | INSULIN ASPART | 1 | Subcutaneous | 0 | |||||||||||
| 126529491 | 12652949 | 7 | C | LEVEMIR | INSULIN DETEMIR | 1 | UNK | 0 | |||||||||||
| 126529491 | 12652949 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 1 MG, 1X/DAY | 0 | 1 | MG | QD | |||||||
| 126529491 | 12652949 | 9 | C | LYRICA | PREGABALIN | 1 | Oral | 75 MG, 2X/DAY | 0 | 75 | MG | BID | |||||||
| 126529491 | 12652949 | 10 | C | PROCRIT | ERYTHROPOIETIN | 1 | Intravenous (not otherwise specified) | UNK, 1X/WEEK | 0 | /wk | |||||||||
| 126529491 | 12652949 | 11 | C | FABB VITAMIN B COMPLEX WITH FOLIC ACID | 2 | Oral | UNK, 1X/DAY | 0 | QD | ||||||||||
| 126529491 | 12652949 | 12 | C | FISH OIL | FISH OIL | 1 | Oral | 1000 MG, 3X/DAY | 0 | 1000 | MG | TID | |||||||
| 126529491 | 12652949 | 13 | C | CLONIDINE. | CLONIDINE | 1 | Oral | 0.1 MG, 2X/DAY | 0 | .1 | MG | BID | |||||||
| 126529491 | 12652949 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 600 MG, 3X/DAY | 0 | 600 | MG | TID | |||||||
| 126529491 | 12652949 | 15 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | UNK, 2X/DAY | 0 | BID | ||||||||||
| 126529491 | 12652949 | 16 | C | AZELASTINE | AZELASTINE | 1 | UNK | 0 | |||||||||||
| 126529491 | 12652949 | 17 | C | CARVEDILOL. | CARVEDILOL | 1 | 25 MG, 2X/DAY | 0 | 25 | MG | BID | ||||||||
| 126529491 | 12652949 | 18 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | 100 MG, 3X/DAY | 0 | 100 | MG | TID | ||||||||
| 126529491 | 12652949 | 19 | C | FREE STYLE GLUCOSE MONITOR | 2 | UNK, AS NEEDED | 0 |
Indications of drugs used
| no results found |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126529491 | 12652949 | Abdominal discomfort | |
| 126529491 | 12652949 | Drug effect increased | |
| 126529491 | 12652949 | Drug hypersensitivity | |
| 126529491 | 12652949 | Nausea | |
| 126529491 | 12652949 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126529491 | 12652949 | 3 | 20100401 | 0 | ||
| 126529491 | 12652949 | 7 | 20121214 | 0 | ||
| 126529491 | 12652949 | 9 | 20140421 | 0 | ||
| 126529491 | 12652949 | 12 | 20120917 | 0 | ||
| 126529491 | 12652949 | 13 | 20150303 | 0 | ||
| 126529491 | 12652949 | 14 | 20150604 | 0 | ||
| 126529491 | 12652949 | 16 | 20141202 | 0 | ||
| 126529491 | 12652949 | 17 | 20130711 | 0 | ||
| 126529491 | 12652949 | 19 | 20141016 | 0 |