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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127967701 | 12796770 | 1 | I | 201508 | 20160921 | 20160929 | 20160929 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00640 | AMNEAL | 48.92 | YR | M | Y | 102.40000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127967701 | 12796770 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 100 MG, 3X/DAY | 78428 | 100 | MG | CAPSULE | TID | ||||||
| 127967701 | 12796770 | 2 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 200 MG, 3X/DAY | 78428 | 200 | MG | CAPSULE | TID | ||||||
| 127967701 | 12796770 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, 3X/DAY | 78428 | 300 | MG | CAPSULE | TID | ||||||
| 127967701 | 12796770 | 4 | SS | LYRICA | PREGABALIN | 1 | Oral | UNK, 1X/DAY | N | 0 | CAPSULE | QD | |||||||
| 127967701 | 12796770 | 5 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127967701 | 12796770 | 6 | C | Uspecified Pain medication | 2 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127967701 | 12796770 | 1 | Neuralgia |
| 127967701 | 12796770 | 4 | Neuralgia |
| 127967701 | 12796770 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127967701 | 12796770 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127967701 | 12796770 | Adverse event | |
| 127967701 | 12796770 | Arthritis | |
| 127967701 | 12796770 | Arthritis infective | |
| 127967701 | 12796770 | Drug ineffective | |
| 127967701 | 12796770 | Hypoaesthesia | |
| 127967701 | 12796770 | Insomnia | |
| 127967701 | 12796770 | Neuralgia | |
| 127967701 | 12796770 | Paraesthesia | |
| 127967701 | 12796770 | Peripheral nerve injury |
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 |
|---|---|---|---|---|---|---|
| 127967701 | 12796770 | 1 | 20160817 | 0 | ||
| 127967701 | 12796770 | 4 | 201606 | 201608 | 0 | |
| 127967701 | 12796770 | 5 | 2006 | 0 |