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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490771 | 12649077 | 1 | I | 2014 | 20160801 | 20160812 | 20160812 | EXP | US-UNICHEM LABORATORIES LIMITED-UCM201608-000168 | UNICHEM | 0.00 | M | Y | 105.23000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490771 | 12649077 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | 90162 | 50 | MG | ||||||||||
| 126490771 | 12649077 | 2 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | 90162 | 100 | MG | BID | |||||||||
| 126490771 | 12649077 | 3 | SS | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | 0 | 500 | MG | TID | ||||||||
| 126490771 | 12649077 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 0 | 3600 | MG | |||||||||
| 126490771 | 12649077 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | 0 | 1800 | MG | ||||||||||
| 126490771 | 12649077 | 6 | SS | TIZANIDINE. | TIZANIDINE | 1 | 0 | 1 | MG | ||||||||||
| 126490771 | 12649077 | 7 | SS | TIZANIDINE. | TIZANIDINE | 1 | 0 | 2 | MG | ||||||||||
| 126490771 | 12649077 | 8 | SS | TIZANIDINE. | TIZANIDINE | 1 | 0 | 4 | MG | QID | |||||||||
| 126490771 | 12649077 | 9 | SS | TIZANIDINE. | TIZANIDINE | 1 | Oral | 0 | |||||||||||
| 126490771 | 12649077 | 10 | SS | RISPERIDONE. | RISPERIDONE | 1 | 0 | 2 | MG | ||||||||||
| 126490771 | 12649077 | 11 | SS | RISPERIDONE. | RISPERIDONE | 1 | 0 | 3 | MG | ||||||||||
| 126490771 | 12649077 | 12 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 | 100 | MG | BID | |||||||||
| 126490771 | 12649077 | 13 | SS | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 | 100 | MG | ||||||||||
| 126490771 | 12649077 | 14 | SS | Doxepin | DOXEPIN | 1 | 0 | 75 | MG | ||||||||||
| 126490771 | 12649077 | 15 | SS | Doxepin | DOXEPIN | 1 | 0 | 25 | MG | ||||||||||
| 126490771 | 12649077 | 16 | SS | Doxepin | DOXEPIN | 1 | 0 | 75 | MG | QD | |||||||||
| 126490771 | 12649077 | 17 | SS | VRAYLAR | CARIPRAZINE | 1 | Oral | 1155709 | 0 | 1.5 | MG | CAPSULE | QD | ||||||
| 126490771 | 12649077 | 18 | SS | VIAGRA | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 126490771 | 12649077 | 19 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | .5 | MG | ||||||||||
| 126490771 | 12649077 | 20 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | 2 | MG | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126490771 | 12649077 | 1 | Affective disorder |
| 126490771 | 12649077 | 3 | Wisdom teeth removal |
| 126490771 | 12649077 | 4 | Fibromyalgia |
| 126490771 | 12649077 | 6 | Muscle relaxant therapy |
| 126490771 | 12649077 | 10 | Psychotic disorder |
| 126490771 | 12649077 | 12 | Insomnia |
| 126490771 | 12649077 | 14 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126490771 | 12649077 | HO |
| 126490771 | 12649077 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126490771 | 12649077 | Barrett's oesophagus | |
| 126490771 | 12649077 | Condition aggravated | |
| 126490771 | 12649077 | Delirium | |
| 126490771 | 12649077 | Dry mouth | |
| 126490771 | 12649077 | Erectile dysfunction | |
| 126490771 | 12649077 | Feeling abnormal | |
| 126490771 | 12649077 | Hallucination | |
| 126490771 | 12649077 | Insomnia | |
| 126490771 | 12649077 | Panic attack | |
| 126490771 | 12649077 | Post-traumatic stress disorder | |
| 126490771 | 12649077 | Product use issue | |
| 126490771 | 12649077 | Sleep terror | |
| 126490771 | 12649077 | Small cell lung cancer | |
| 126490771 | 12649077 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 126490771 | 12649077 | 3 | 20160621 | 0 | ||
| 126490771 | 12649077 | 4 | 2009 | 0 | ||
| 126490771 | 12649077 | 6 | 2009 | 0 | ||
| 126490771 | 12649077 | 10 | 1995 | 0 | ||
| 126490771 | 12649077 | 12 | 2015 | 0 | ||
| 126490771 | 12649077 | 19 | 1995 | 0 | ||
| 126490771 | 12649077 | 20 | 2014 | 0 |