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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116314353 | 11631435 | 3 | F | 2014 | 20150119 | 20151015 | 20160729 | PER | US-GLENMARK PHARMACEUTICALS INC, USA.-2014GMK012142 | GLENMARK | 0.00 | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116314353 | 11631435 | 1 | PS | PRAMIPEXOLE DIHYDROCHLORIDE. | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1 DF, OD AT NIGHT | 90781 | 1 | DF | TABLET | QD | ||||||
| 116314353 | 11631435 | 2 | SS | PRAMIPEXOLE DIHYDROCHLORIDE. | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Oral | 1 DF, HS | 90781 | 1 | DF | TABLET | |||||||
| 116314353 | 11631435 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 1 DF, BID, ONE TABLET AT NIGHT | U | 0 | 1 | DF | TABLET | BID | |||||
| 116314353 | 11631435 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 1 DF, HS | U | 0 | 1 | DF | TABLET | ||||||
| 116314353 | 11631435 | 5 | C | ROPINIROLE. | ROPINIROLE | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 6 | C | DIVALPROEX | DIVALPROEX SODIUM | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 8 | C | CLOZAPINE. | CLOZAPINE | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 9 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 10 | C | ZONISAMIDE. | ZONISAMIDE | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 11 | C | CARBIDOPA. | CARBIDOPA | 1 | UNK | 0 | |||||||||||
| 116314353 | 11631435 | 12 | C | LEVODOPA | LEVODOPA | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116314353 | 11631435 | 5 | Product used for unknown indication |
| 116314353 | 11631435 | 7 | Product used for unknown indication |
| 116314353 | 11631435 | 8 | Product used for unknown indication |
| 116314353 | 11631435 | 9 | Product used for unknown indication |
| 116314353 | 11631435 | 10 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116314353 | 11631435 | Drug ineffective | |
| 116314353 | 11631435 | Incorrect dosage administered | |
| 116314353 | 11631435 | Product use issue | |
| 116314353 | 11631435 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 116314353 | 11631435 | 1 | 2014 | 20141112 | 0 | |
| 116314353 | 11631435 | 2 | 20141208 | 0 | ||
| 116314353 | 11631435 | 3 | 2014 | 0 | ||
| 116314353 | 11631435 | 4 | 20141208 | 0 |