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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108653243 | 10865324 | 3 | F | 2014 | 20141201 | 20150224 | 20160729 | EXP | US-MYLANLABS-2014M1010362 | MYLAN | 0.00 | F | Y | 91.61000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108653243 | 10865324 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 40 MG, QD | N | 75945 | 40 | MG | CAPSULE | QD | |||||
| 108653243 | 10865324 | 2 | SS | AMNESTEEM | ISOTRETINOIN | 1 | N | 75945 | CAPSULE | ||||||||||
| 108653243 | 10865324 | 3 | SS | AMNESTEEM | ISOTRETINOIN | 1 | N | 75945 | CAPSULE | ||||||||||
| 108653243 | 10865324 | 4 | SS | CLARAVIS | ISOTRETINOIN | 1 | UNK | N | 0 | ||||||||||
| 108653243 | 10865324 | 5 | SS | CLARAVIS | ISOTRETINOIN | 1 | N | 0 | |||||||||||
| 108653243 | 10865324 | 6 | SS | CLARAVIS | ISOTRETINOIN | 1 | N | 0 | |||||||||||
| 108653243 | 10865324 | 7 | C | ORTHO-TRI-CYCLEN 21 | 2 | U | 0 | ||||||||||||
| 108653243 | 10865324 | 8 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 108653243 | 10865324 | 9 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108653243 | 10865324 | 1 | Keratosis follicular |
| 108653243 | 10865324 | 2 | Hidradenitis |
| 108653243 | 10865324 | 3 | Off label use |
| 108653243 | 10865324 | 5 | Hidradenitis |
| 108653243 | 10865324 | 6 | Keratosis follicular |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108653243 | 10865324 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108653243 | 10865324 | Drug ineffective for unapproved indication | |
| 108653243 | 10865324 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 108653243 | 10865324 | 1 | 20140527 | 20141001 | 0 | |
| 108653243 | 10865324 | 4 | 2014 | 2014 | 0 |