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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108653172 | 10865317 | 2 | F | 201410 | 20141202 | 20150224 | 20160729 | EXP | US-MYLANLABS-2014M1009139 | MYLAN | 19.40 | YR | M | Y | 92.97000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108653172 | 10865317 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 40 MG, BID | Y | 064959 | 75945 | 40 | MG | CAPSULE | BID | ||||
| 108653172 | 10865317 | 2 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | N | 0 | ||||||||||
| 108653172 | 10865317 | 3 | C | FLONASE /00908302/ | MOMETASONE FUROATE | 1 | UNK | 064959 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108653172 | 10865317 | 1 | Acne cystic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108653172 | 10865317 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108653172 | 10865317 | Acne | |
| 108653172 | 10865317 | Arthralgia | |
| 108653172 | 10865317 | Cough | |
| 108653172 | 10865317 | Dry skin | |
| 108653172 | 10865317 | Fatigue | |
| 108653172 | 10865317 | Flushing | |
| 108653172 | 10865317 | Oropharyngeal pain | |
| 108653172 | 10865317 | Pain of skin | |
| 108653172 | 10865317 | Pulmonary congestion | |
| 108653172 | 10865317 | Skin exfoliation | |
| 108653172 | 10865317 | Sunburn | |
| 108653172 | 10865317 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 108653172 | 10865317 | 1 | 20141008 | 20141014 | 0 |