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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119996622 | 11999662 | 2 | F | 20150624 | 20160204 | 20160728 | PER | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2008US-14439 | RANBAXY | 0.00 | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119996622 | 11999662 | 1 | SS | Isotretinoin | ISOTRETINOIN | 1 | 40 MG, UNK | U | 0 | 40 | MG | CAPSULE | |||||||
| 119996622 | 11999662 | 2 | SS | Isotretinoin | ISOTRETINOIN | 1 | 30 MG, UNK | U | 0 | CAPSULE | |||||||||
| 119996622 | 11999662 | 3 | PS | Isotretinoin | ISOTRETINOIN | 1 | U | 76503 | CAPSULE | ||||||||||
| 119996622 | 11999662 | 4 | SS | ACCUTANE | ISOTRETINOIN | 1 | 10 MG, UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119996622 | 11999662 | 1 | Product used for unknown indication |
| 119996622 | 11999662 | 3 | Product used for unknown indication |
| 119996622 | 11999662 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119996622 | 11999662 | Irritability | |
| 119996622 | 11999662 | Personality change |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |