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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126477041 | 12647704 | 1 | I | 2009 | 20151001 | 20160812 | 20160812 | EXP | GB-AUROBINDO-AUR-APL-2015-08822 | AUROBINDO | 51.00 | YR | F | Y | 0.00000 | 20160812 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126477041 | 12647704 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 100.0MG UNKNOWN | N | U | 78619 | 100 | MG | ||||||
| 126477041 | 12647704 | 2 | SS | Quetiapine Film-Coated Tablet | QUETIAPINE | 1 | Unknown | 400 MG, TWO TIMES A DAY | N | U | 0 | 400 | MG | FILM-COATED TABLET | BID | ||||
| 126477041 | 12647704 | 3 | SS | Quetiapine Film-Coated Tablet | QUETIAPINE | 1 | Oral | UNK | N | U | 0 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126477041 | 12647704 | 1 | Anxiety |
| 126477041 | 12647704 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126477041 | 12647704 | HO |
| 126477041 | 12647704 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126477041 | 12647704 | Agitation | |
| 126477041 | 12647704 | Asthma | |
| 126477041 | 12647704 | Death | |
| 126477041 | 12647704 | Drug withdrawal syndrome | |
| 126477041 | 12647704 | Interstitial lung disease | |
| 126477041 | 12647704 | Overdose | |
| 126477041 | 12647704 | Pneumonia | |
| 126477041 | 12647704 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 126477041 | 12647704 | 1 | 2008 | 0 |