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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125758511 | 12575851 | 1 | I | 2016 | 20160706 | 20160720 | 20160720 | EXP | US-AKORN PHARMACEUTICALS-2016AKN00445 | AKORN | 0.00 | M | Y | 83.90000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125758511 | 12575851 | 1 | PS | MYORISAN | ISOTRETINOIN | 1 | Oral | UNK UNK, 2X/DAY | Y | 76485 | CAPSULE | ||||||||
| 125758511 | 12575851 | 2 | SS | MYORISAN | ISOTRETINOIN | 1 | Oral | 1 TABLETS, 2X/DAY | Y | 76485 | 1 | DF | CAPSULE | BID | |||||
| 125758511 | 12575851 | 3 | SS | CLARAVIS | ISOTRETINOIN | 1 | UNK | Y | 0 | ||||||||||
| 125758511 | 12575851 | 4 | C | LANTUS | INSULIN GLARGINE | 1 | 0 | ||||||||||||
| 125758511 | 12575851 | 5 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125758511 | 12575851 | 6 | C | NOVOLOG | INSULIN ASPART | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125758511 | 12575851 | 2 | Acne |
| 125758511 | 12575851 | 3 | Acne |
| 125758511 | 12575851 | 6 | Acne |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125758511 | 12575851 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125758511 | 12575851 | Anger | |
| 125758511 | 12575851 | Mood swings |
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 |
|---|---|---|---|---|---|---|
| 125758511 | 12575851 | 1 | 20160212 | 2016 | 0 | |
| 125758511 | 12575851 | 2 | 20160421 | 201606 | 0 | |
| 125758511 | 12575851 | 3 | 20160311 | 2016 | 0 |