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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122007002 | 12200700 | 2 | F | 20150823 | 20160823 | 20160322 | 20160831 | EXP | US-INDIVIOR LIMITED-INDV-088941-2016 | INDIVIOR | 37.00 | YR | M | Y | 78.00000 | KG | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122007002 | 12200700 | 1 | PS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | Oral | UNK | Y | UNKNOWN | 22410 | ||||||||
| 122007002 | 12200700 | 2 | C | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 TABLET, DAILY | Y | 0 | |||||||||
| 122007002 | 12200700 | 3 | C | BENAZEPRIL | BENAZEPRIL HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 4 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 6 | C | DEXTROMETHORPHAN | DEXTROMETHORPHAN | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 7 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 8 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122007002 | 12200700 | 10 | C | PROTONIX /00661201/ | OMEPRAZOLE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122007002 | 12200700 | 1 | Drug dependence |
| 122007002 | 12200700 | 2 | Chronic hepatitis C |
| 122007002 | 12200700 | 3 | Product used for unknown indication |
| 122007002 | 12200700 | 4 | Product used for unknown indication |
| 122007002 | 12200700 | 5 | Product used for unknown indication |
| 122007002 | 12200700 | 6 | Product used for unknown indication |
| 122007002 | 12200700 | 7 | Product used for unknown indication |
| 122007002 | 12200700 | 8 | Product used for unknown indication |
| 122007002 | 12200700 | 9 | Product used for unknown indication |
| 122007002 | 12200700 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122007002 | 12200700 | HO |
| 122007002 | 12200700 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122007002 | 12200700 | Drug dose omission | |
| 122007002 | 12200700 | Hallucination | |
| 122007002 | 12200700 | Malaise | |
| 122007002 | 12200700 | Mental disorder | |
| 122007002 | 12200700 | Substance-induced psychotic disorder | |
| 122007002 | 12200700 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 122007002 | 12200700 | 1 | 20150820 | 20150824 | 0 | |
| 122007002 | 12200700 | 2 | 201606 | 0 |