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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126926311 | 12692631 | 1 | I | 20160307 | 20160310 | 20160829 | 20160829 | PER | US-AJANTA PHARMA USA INC.-1056816 | AJANTA PHARMA | 58.00 | YR | M | Y | 104.55000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126926311 | 12692631 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | Y | 201003 | .5 | MG | TABLET | |||||||
| 126926311 | 12692631 | 2 | C | KLONOPIN | CLONAZEPAM | 1 | 0 | .5 | MG | BID | |||||||||
| 126926311 | 12692631 | 3 | C | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | 0 | 10 | MG | QD | |||||||||
| 126926311 | 12692631 | 4 | C | GUANFACINE EXTENDED-RELEASE | GUANFACINE | 1 | 0 | QD | |||||||||||
| 126926311 | 12692631 | 5 | C | Melatonin | MELATONIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126926311 | 12692631 | 1 | Autism spectrum disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126926311 | 12692631 | Disturbance in attention | |
| 126926311 | 12692631 | Listless | |
| 126926311 | 12692631 | Mania | |
| 126926311 | 12692631 | Overdose | |
| 126926311 | 12692631 | Product substitution issue | |
| 126926311 | 12692631 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126926311 | 12692631 | 1 | 20160307 | 20160308 | 0 |