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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126013401 | 12601340 | 1 | I | 20070314 | 20070525 | 20160728 | 20160728 | PER | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2007US-08489 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126013401 | 12601340 | 1 | PS | Isotretinoin | ISOTRETINOIN | 1 | Oral | 30 MG, BID | 650 | MG | U | 76503 | 30 | MG | CAPSULE | Q12H | |||
126013401 | 12601340 | 2 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
126013401 | 12601340 | 3 | C | Birth control pills | UNSPECIFIED INGREDIENT | 1 | U | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126013401 | 12601340 | 1 | Acne |
126013401 | 12601340 | 2 | Product used for unknown indication |
126013401 | 12601340 | 3 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126013401 | 12601340 | Anger | |
126013401 | 12601340 | Crying | |
126013401 | 12601340 | Irritability | |
126013401 | 12601340 | Mood swings |
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 |
---|---|---|---|---|---|---|
126013401 | 12601340 | 1 | 20070305 | 20070317 | 0 |