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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464921 | 12546492 | 1 | I | 20151125 | 20160627 | 20160711 | 20160711 | EXP | JP-CONCORDIA PHARMACEUTICALS INC.-CO-ZO-US-2016-078 | CONCORDIA | 32.33 | YR | M | Y | 0.00000 | 20160711 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125464921 | 12546492 | 1 | PS | ZONEGRAN | ZONISAMIDE | 1 | Oral | 100 MG | U | 20789 | TABLET | ||||||||
| 125464921 | 12546492 | 2 | SS | ZONEGRAN | ZONISAMIDE | 1 | Oral | U | 20789 | 50 | MG | POWDER | BID | ||||||
| 125464921 | 12546492 | 3 | SS | SERENACE | HALOPERIDOL | 1 | Intramuscular | Y | 0 | 5 | MG | INJECTION | QD | ||||||
| 125464921 | 12546492 | 4 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 1000 MG | 0 | UNKNOWN | |||||||||
| 125464921 | 12546492 | 5 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 1000 MG | 0 | SYRUP | |||||||||
| 125464921 | 12546492 | 6 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 0 | 500 | MG | FINE GRANULES | BID | |||||||
| 125464921 | 12546492 | 7 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 60 MG | 0 | UNKNOWN | |||||||||
| 125464921 | 12546492 | 8 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 60 MG | 0 | UNKNOWN | |||||||||
| 125464921 | 12546492 | 9 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 60 MG | 0 | UNKNOWN | |||||||||
| 125464921 | 12546492 | 10 | C | ZOSYN | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 4.5 | G | UNKNOWN | TID | |||||||
| 125464921 | 12546492 | 11 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 0 | 15 | MG | TABLET | QD | |||||||
| 125464921 | 12546492 | 12 | C | ISOZOL | THIAMYLAL SODIUM | 1 | Intravenous (not otherwise specified) | 0 | .5 | G | UNKNOWN | QD | |||||||
| 125464921 | 12546492 | 13 | C | ATROPINE SULFATE. | ATROPINE SULFATE | 1 | Intravenous (not otherwise specified) | 0 | .5 | MG | UNKNOWN | QD | |||||||
| 125464921 | 12546492 | 14 | C | ELENTAL | AMINO ACIDSCARBOHYDRATESMINERALSSOYBEAN OILVITAMINS | 1 | Oral | 0 | 1 | DF | UNKNOWN | TID | |||||||
| 125464921 | 12546492 | 15 | C | ESCRE | 2 | Rectal | 0 | 500 | MG | SUPPOSITORY | QD | ||||||||
| 125464921 | 12546492 | 16 | C | DIAPP | DIAZEPAM | 1 | Rectal | 0 | 10 | MG | SUPPOSITORY | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125464921 | 12546492 | 1 | Epilepsy |
| 125464921 | 12546492 | 3 | Sedative therapy |
| 125464921 | 12546492 | 4 | Epilepsy |
| 125464921 | 12546492 | 7 | Sedative therapy |
| 125464921 | 12546492 | 10 | Infection |
| 125464921 | 12546492 | 11 | Gastric ulcer |
| 125464921 | 12546492 | 12 | Anaesthesia procedure |
| 125464921 | 12546492 | 13 | Anaesthetic premedication |
| 125464921 | 12546492 | 14 | Nutritional supplementation |
| 125464921 | 12546492 | 15 | Sedative therapy |
| 125464921 | 12546492 | 16 | Sedative therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125464921 | 12546492 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125464921 | 12546492 | Neuroleptic malignant syndrome |
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 |
|---|---|---|---|---|---|---|
| 125464921 | 12546492 | 1 | 20110609 | 2015 | 0 | |
| 125464921 | 12546492 | 2 | 20151209 | 0 | ||
| 125464921 | 12546492 | 3 | 20151125 | 20151125 | 0 | |
| 125464921 | 12546492 | 4 | 20110609 | 20151126 | 0 | |
| 125464921 | 12546492 | 5 | 20151127 | 20151208 | 0 | |
| 125464921 | 12546492 | 6 | 20151209 | 0 | ||
| 125464921 | 12546492 | 7 | 20151113 | 20151118 | 0 | |
| 125464921 | 12546492 | 8 | 20151120 | 20151124 | 0 | |
| 125464921 | 12546492 | 9 | 20151126 | 20151206 | 0 | |
| 125464921 | 12546492 | 10 | 20151113 | 20151207 | 0 | |
| 125464921 | 12546492 | 11 | 20151118 | 20151124 | 0 | |
| 125464921 | 12546492 | 12 | 20151120 | 20151120 | 0 | |
| 125464921 | 12546492 | 13 | 20151120 | 20151120 | 0 | |
| 125464921 | 12546492 | 14 | 20151121 | 20151203 | 0 | |
| 125464921 | 12546492 | 15 | 20151124 | 20151125 | 0 | |
| 125464921 | 12546492 | 16 | 20151124 | 20151125 | 0 |