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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126520431 | 12652043 | 1 | I | 20150108 | 20150109 | 20160815 | 20160815 | EXP | US-MYLANLABS-2015M1001057 | MYLAN | 28.84 | YR | F | Y | 58.96000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126520431 | 12652043 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 60 MG, QD | Y | 75945 | 60 | MG | CAPSULE | QD | |||||
| 126520431 | 12652043 | 2 | SS | MYORISAN | ISOTRETINOIN | 1 | UNK | Y | 0 | CAPSULE | |||||||||
| 126520431 | 12652043 | 3 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | UNK UNK, PRN | 0 | |||||||||||
| 126520431 | 12652043 | 4 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | 1000 IU, QD | 0 | 1000 | IU | QD | ||||||||
| 126520431 | 12652043 | 5 | C | KLONOPIN | CLONAZEPAM | 1 | 0.5 MG, PRN | 0 | .5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126520431 | 12652043 | 1 | Acne cystic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126520431 | 12652043 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126520431 | 12652043 | Haematochezia | |
| 126520431 | 12652043 | Mucous stools |
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 |
|---|---|---|---|---|---|---|
| 126520431 | 12652043 | 1 | 201410 | 20150108 | 0 | |
| 126520431 | 12652043 | 2 | 2014 | 2014 | 0 |