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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124216322 | 12421632 | 2 | F | 20160527 | 20160531 | 20160720 | EXP | US-MYLANLABS-2016M1022248 | MYLAN | GUIMERA AL, KULKARNI D. ALTERED MENTAL STATUS IN A 14-YEAR-OLD GIRL. PEDIATR-REV 2016;37(4):175-176. | 0.00 | Y | 0.00000 | 20160720 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124216322 | 12421632 | 1 | PS | CLONIDINE. | CLONIDINE | 1 | Oral | 76166 | TRANSDERMAL PATCH | ||||||||||
| 124216322 | 12421632 | 2 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | 76166 | TRANSDERMAL PATCH | ||||||||||
| 124216322 | 12421632 | 3 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0 | |||||||||||
| 124216322 | 12421632 | 4 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124216322 | 12421632 | 1 | Autism spectrum disorder |
| 124216322 | 12421632 | 2 | Learning disability |
| 124216322 | 12421632 | 3 | Autism spectrum disorder |
| 124216322 | 12421632 | 4 | Learning disability |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124216322 | 12421632 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124216322 | 12421632 | Hypotension | |
| 124216322 | 12421632 | Incorrect route of drug administration | |
| 124216322 | 12421632 | Mental disorder | |
| 124216322 | 12421632 | Off label use | |
| 124216322 | 12421632 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |