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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255421 | 12525542 | 1 | I | 20160331 | 20160705 | 20160705 | PER | US-MLMSERVICE-20160401-0227257-1 | US-LUPIN PHARMACEUTICALS INC.-2016-01369 | LUPIN | MOORE K, DIXIT D, WAGNER M. TOPIRAMATE-RELATED HYPERAMMONEMIA. JOURNAL OF PHARMACY TECHNOLOGY. 2016;32(1):34-36. | 56.00 | YR | F | Y | 46.40000 | KG | 20160705 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255421 | 12525542 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | Y | UNKNOWN | 78410 | 100 | MG | QD | ||||||
| 125255421 | 12525542 | 2 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 78410 | 100 | MG | BID | ||||||
| 125255421 | 12525542 | 3 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 50 MG ONCE IN THE MORNING; 100 MG IN THE EVENING | Y | UNKNOWN | 78410 | ||||||||
| 125255421 | 12525542 | 4 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 78410 | 50 | MG | BID | ||||||
| 125255421 | 12525542 | 5 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 78410 | 50 | MG | QD | ||||||
| 125255421 | 12525542 | 6 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Intravenous (not otherwise specified) | 1500 MG IN THE MORNING; 750 MG IN THE EVENING | UNKNOWN | 0 | |||||||||
| 125255421 | 12525542 | 7 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 750 | MG | Q8H | |||||||
| 125255421 | 12525542 | 8 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Intravenous (not otherwise specified) | 750 MG IN THE MORNING; 500 MG IN THE EVENING | UNKNOWN | 0 | |||||||||
| 125255421 | 12525542 | 9 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 500 | MG | BID | |||||||
| 125255421 | 12525542 | 10 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | BID | ||||||||
| 125255421 | 12525542 | 11 | C | ALBUTEROL. | ALBUTEROL | 1 | FOUR TIMES A DAY AS NEEDED | 0 | 2 | DF | INHALER | ||||||||
| 125255421 | 12525542 | 12 | C | Fluticasone/salmeterol | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 250 MG/50 MICROGRAM, 1 PUFF INHALED TWICE DAILY | 0 | INHALER | ||||||||||
| 125255421 | 12525542 | 13 | C | Hydromorphone | HYDROMORPHONE | 1 | Oral | 1 TO 2 TABLETS, EVERY 6 HOURS AS NEEDED | 0 | ||||||||||
| 125255421 | 12525542 | 14 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Oral | 30 MG | 0 | ||||||||||
| 125255421 | 12525542 | 15 | C | DULOXETINE. | DULOXETINE | 1 | Oral | 60 MG | 0 | ||||||||||
| 125255421 | 12525542 | 16 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 0 | 1500 | MG | BID | ||||||||
| 125255421 | 12525542 | 17 | C | Eletriptan | ELETRIPTAN | 1 | Oral | 40 MG | 0 | ||||||||||
| 125255421 | 12525542 | 18 | C | ZOLMITRIPTAN. | ZOLMITRIPTAN | 1 | Nasal | 5 MG | 0 | ||||||||||
| 125255421 | 12525542 | 19 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 100 MG | 0 | ||||||||||
| 125255421 | 12525542 | 20 | C | Rabeprazole | RABEPRAZOLE | 1 | Oral | 20 MG | 0 | ||||||||||
| 125255421 | 12525542 | 21 | C | Trimethobenzamide | TRIMETHOBENZAMIDE | 1 | Oral | EVERY 8 HOURS AS NEEDED | 0 | 250 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125255421 | 12525542 | 1 | Migraine prophylaxis |
| 125255421 | 12525542 | 6 | Myoclonic epilepsy |
| 125255421 | 12525542 | 10 | Product used for unknown indication |
| 125255421 | 12525542 | 11 | Product used for unknown indication |
| 125255421 | 12525542 | 12 | Product used for unknown indication |
| 125255421 | 12525542 | 13 | Product used for unknown indication |
| 125255421 | 12525542 | 14 | Product used for unknown indication |
| 125255421 | 12525542 | 15 | Product used for unknown indication |
| 125255421 | 12525542 | 16 | Pain |
| 125255421 | 12525542 | 17 | Migraine |
| 125255421 | 12525542 | 18 | Migraine |
| 125255421 | 12525542 | 19 | Product used for unknown indication |
| 125255421 | 12525542 | 20 | Product used for unknown indication |
| 125255421 | 12525542 | 21 | Nausea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125255421 | 12525542 | HO |
| 125255421 | 12525542 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125255421 | 12525542 | Drug interaction | |
| 125255421 | 12525542 | Hyperammonaemia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |