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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067131 | 12606713 | 1 | I | 20160712 | 20160718 | 20160729 | 20160729 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00405 | AMNEAL | 28.38 | YR | F | Y | 68.93000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126067131 | 12606713 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | THREE TABLETS , ONE TIME A DAY | AR151418 (POSSIBLE) | 78428 | CAPSULE | ||||||||
| 126067131 | 12606713 | 2 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | AR151418 (POSSIBLE) | 78428 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126067131 | 12606713 | 1 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126067131 | 12606713 | HO |
| 126067131 | 12606713 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126067131 | 12606713 | Anger | |
| 126067131 | 12606713 | Arthralgia | |
| 126067131 | 12606713 | Asthenia | |
| 126067131 | 12606713 | Back pain | |
| 126067131 | 12606713 | Blood urine present | |
| 126067131 | 12606713 | Condition aggravated | |
| 126067131 | 12606713 | Feeling abnormal | |
| 126067131 | 12606713 | Heart rate increased | |
| 126067131 | 12606713 | Loss of consciousness | |
| 126067131 | 12606713 | Oropharyngeal pain | |
| 126067131 | 12606713 | Pain in extremity | |
| 126067131 | 12606713 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |