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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127264921 | 12726492 | 1 | I | 20140830 | 20150811 | 20160908 | 20160908 | EXP | US-AMNEAL PHARMACEUTICALS-2015AMN00105 | AMNEAL | 35.00 | YR | M | Y | 0.00000 | 20160908 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127264921 | 12726492 | 1 | PS | BUPRENORPHINE AND NALOXONE | BUPRENORPHINENALOXONE | 1 | 8MG, 2X/DAY | UNKNOWN | 203136 | SUBLINGUAL TABLET | |||||||||
| 127264921 | 12726492 | 2 | SS | HYDROXYZINE HYDROCHLORIDE. | HYDROXYZINE HYDROCHLORIDE | 1 | UNK | U | UNKNOWN | 0 | TABLET | ||||||||
| 127264921 | 12726492 | 3 | SS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | UNK | UNKNOWN | 0 | TABLET | |||||||||
| 127264921 | 12726492 | 4 | C | QUETIAPINE. | QUETIAPINE | 1 | 50 UNK, UNK | 0 | |||||||||||
| 127264921 | 12726492 | 5 | C | QUETIAPINE. | QUETIAPINE | 1 | 0 | ||||||||||||
| 127264921 | 12726492 | 6 | C | QUETIAPINE. | QUETIAPINE | 1 | 0 | ||||||||||||
| 127264921 | 12726492 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | 30 MG, UNK | 0 | 30 | MG | |||||||||
| 127264921 | 12726492 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 10 | C | ATOMOXETINE | ATOMOXETINE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 11 | C | ATOMOXETINE | ATOMOXETINE | 1 | 80 MG, UNK | 0 | 80 | MG | |||||||||
| 127264921 | 12726492 | 12 | C | DULOXETINE. | DULOXETINE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 13 | C | NICOTINE RESIN | NICOTINE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 14 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 15 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 16 | C | TEMAZEPAM. | TEMAZEPAM | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 17 | C | TUBERCULIN NOS | TUBERCULIN PURIFIED PROTEIN DERIVATIVE | 1 | UNK | 0 | |||||||||||
| 127264921 | 12726492 | 18 | C | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127264921 | 12726492 | 1 | Pain |
| 127264921 | 12726492 | 4 | Anxiety |
| 127264921 | 12726492 | 5 | Agitation |
| 127264921 | 12726492 | 6 | Insomnia |
| 127264921 | 12726492 | 15 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127264921 | 12726492 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127264921 | 12726492 | Drug dependence | |
| 127264921 | 12726492 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 127264921 | 12726492 | 1 | 20140828 | 20140830 | 0 | |
| 127264921 | 12726492 | 2 | 20140830 | 0 | ||
| 127264921 | 12726492 | 3 | 20140830 | 0 |