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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269632 | 12626963 | 2 | F | 2016 | 20160819 | 20160805 | 20160831 | EXP | US-AKORN PHARMACEUTICALS-2016AKN00479 | AKORN | 0.00 | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269632 | 12626963 | 1 | PS | MYORISAN | ISOTRETINOIN | 1 | 20 MG, 2X/DAY | Y | 76485 | 20 | MG | CAPSULE | BID | ||||||
| 126269632 | 12626963 | 2 | SS | MYORISAN | ISOTRETINOIN | 1 | 30 MG, 2X/DAY | Y | 76485 | 30 | MG | CAPSULE | BID | ||||||
| 126269632 | 12626963 | 3 | SS | MYORISAN | ISOTRETINOIN | 1 | 30 MG, 1X/DAY | Y | 76485 | 30 | MG | CAPSULE | QD | ||||||
| 126269632 | 12626963 | 4 | SS | CLARAVIS | ISOTRETINOIN | 1 | 30 MG, 2X/DAY | Y | 0 | 30 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126269632 | 12626963 | 1 | Acne cystic |
| 126269632 | 12626963 | 2 | Acne cystic |
| 126269632 | 12626963 | 4 | Acne cystic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126269632 | 12626963 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126269632 | 12626963 | Affect lability | |
| 126269632 | 12626963 | Anxiety | |
| 126269632 | 12626963 | Stress | |
| 126269632 | 12626963 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 126269632 | 12626963 | 1 | 20160310 | 20160414 | 0 | |
| 126269632 | 12626963 | 2 | 20160516 | 20160718 | 0 | |
| 126269632 | 12626963 | 3 | 20160718 | 20160810 | 0 | |
| 126269632 | 12626963 | 4 | 20160415 | 20160515 | 0 |