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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127175101 | 12717510 | 1 | I | 20160212 | 20160906 | 20160906 | PER | US-AMNEAL PHARMACEUTICALS-2016AMN00111 | AMNEAL | 0.00 | F | Y | 86.17000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127175101 | 12717510 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, ONE IN THE MORNING, ONE IN THE AFTERNOON AND TWO IN THE EVENING | N | UNKNOWN | 78428 | 300 | MG | CAPSULE | |||||
| 127175101 | 12717510 | 2 | SS | GABAPENTIN. | GABAPENTIN | 1 | N | 78428 | CAPSULE | ||||||||||
| 127175101 | 12717510 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | N | 78428 | CAPSULE | ||||||||||
| 127175101 | 12717510 | 4 | C | Hydrocodone | HYDROCODONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127175101 | 12717510 | 1 | Fibromyalgia |
| 127175101 | 12717510 | 2 | Osteoporosis |
| 127175101 | 12717510 | 3 | Back pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127175101 | 12717510 | Drug ineffective | |
| 127175101 | 12717510 | Feeling abnormal | |
| 127175101 | 12717510 | Off label use | |
| 127175101 | 12717510 | Poor quality sleep | |
| 127175101 | 12717510 | Somnolence | |
| 127175101 | 12717510 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127175101 | 12717510 | 1 | 201509 | 0 |