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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127136811 | 12713681 | 1 | I | 20160820 | 20160904 | 20160904 | EXP | US-CATALENT PHARMA SOLUTIONS-CAT-000058-2016 | CATALENT PHARMA | AIYER R SEIDE M STERN RG. VALPROIC ACID INDUCED HYPERAMMONEMIA IN A LONG TIME TREATED PATIENT.. CASE REPORTS IN PSYCHIATRY. 2016;1-4 | 58.00 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127136811 | 12713681 | 1 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | 1000 MG, BID | 0 | 1000 | MG | ||||||||
| 127136811 | 12713681 | 2 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | 0 | ||||||||||||
| 127136811 | 12713681 | 3 | C | Atorvastatin | ATORVASTATIN | 1 | Oral | 10 MG AT NIGHT | 0 | ||||||||||
| 127136811 | 12713681 | 4 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 175 MCG, QD | 0 | ||||||||||
| 127136811 | 12713681 | 5 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 12.5 MG, BID | 0 | 12.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127136811 | 12713681 | 1 | Bipolar disorder |
| 127136811 | 12713681 | 2 | Mood altered |
| 127136811 | 12713681 | 3 | Product used for unknown indication |
| 127136811 | 12713681 | 4 | Product used for unknown indication |
| 127136811 | 12713681 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127136811 | 12713681 | OT |
| 127136811 | 12713681 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127136811 | 12713681 | Affect lability | |
| 127136811 | 12713681 | Aggression | |
| 127136811 | 12713681 | Agitation | |
| 127136811 | 12713681 | Anger | |
| 127136811 | 12713681 | Asthenia | |
| 127136811 | 12713681 | Belligerence | |
| 127136811 | 12713681 | Cognitive disorder | |
| 127136811 | 12713681 | Emotional distress | |
| 127136811 | 12713681 | Hyperammonaemia | |
| 127136811 | 12713681 | Irritability | |
| 127136811 | 12713681 | Mania | |
| 127136811 | 12713681 | Neglect of personal appearance | |
| 127136811 | 12713681 | Sinus tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |