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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126873972 | 12687397 | 2 | F | 2016 | 20160907 | 20160825 | 20160919 | EXP | US-AKORN PHARMACEUTICALS-2016AKN00549 | AKORN | 0.00 | F | Y | 0.00000 | 20160919 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126873972 | 12687397 | 1 | PS | MYORISAN | ISOTRETINOIN | 1 | Oral | 20 MG, 2X/DAY | Y | 76485 | 20 | MG | CAPSULE | BID | |||||
| 126873972 | 12687397 | 2 | SS | MYORISAN | ISOTRETINOIN | 1 | Oral | 1 TABLETS, 1X/DAY | Y | 76485 | 1 | DF | CAPSULE | QD | |||||
| 126873972 | 12687397 | 3 | SS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 1 TABLETS, 1X/DAY | Y | 0 | 1 | DF | QD | ||||||
| 126873972 | 12687397 | 4 | SS | CLARAVIS | ISOTRETINOIN | 1 | Oral | 1 TABLETS, 1X/DAY | Y | 0 | 1 | DF | QD | ||||||
| 126873972 | 12687397 | 5 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126873972 | 12687397 | 6 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | ||||||||||||
| 126873972 | 12687397 | 7 | C | LOSARTAN. | LOSARTAN | 1 | 0 | ||||||||||||
| 126873972 | 12687397 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 126873972 | 12687397 | 9 | C | AMETHIA LO | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126873972 | 12687397 | 1 | Acne cystic |
| 126873972 | 12687397 | 2 | Acne cystic |
| 126873972 | 12687397 | 3 | Acne cystic |
| 126873972 | 12687397 | 4 | Acne cystic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126873972 | 12687397 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126873972 | 12687397 | Irritability | |
| 126873972 | 12687397 | Myalgia | |
| 126873972 | 12687397 | Stress |
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 |
|---|---|---|---|---|---|---|
| 126873972 | 12687397 | 1 | 20160503 | 2016 | 0 | |
| 126873972 | 12687397 | 2 | 20160708 | 2016 | 0 | |
| 126873972 | 12687397 | 3 | 20160602 | 2016 | 0 | |
| 126873972 | 12687397 | 4 | 20160602 | 2016 | 0 |