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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126079281 | 12607928 | 1 | I | 2015 | 20150513 | 20160729 | 20160729 | EXP | US-MYLANLABS-2015M1016516 | MYLAN | 15.96 | YR | M | Y | 70.60000 | KG | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126079281 | 12607928 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | UNK | Y | 75945 | CAPSULE | |||||||||
| 126079281 | 12607928 | 2 | SS | CLARAVIS | ISOTRETINOIN | 1 | Oral | 30 MG, QD | Y | 0 | 30 | MG | QD | ||||||
| 126079281 | 12607928 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126079281 | 12607928 | 1 | Acne cystic |
| 126079281 | 12607928 | 2 | Acne cystic |
| 126079281 | 12607928 | 3 | Arthralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126079281 | 12607928 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126079281 | 12607928 | Arthralgia | |
| 126079281 | 12607928 | Aspartate aminotransferase increased | |
| 126079281 | 12607928 | Blood creatine phosphokinase increased | |
| 126079281 | 12607928 | Osteochondrosis |
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 |
|---|---|---|---|---|---|---|
| 126079281 | 12607928 | 1 | 2015 | 201505 | 0 | |
| 126079281 | 12607928 | 2 | 201502 | 2015 | 0 |