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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105966715 | 10596671 | 5 | F | 20140903 | 20160912 | 20141120 | 20160919 | EXP | GB-OTSUKA-EU-2014-10571 | OTSUKA | 22.00 | YR | M | Y | 44.45000 | KG | 20160919 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105966715 | 10596671 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | UNK | D | 202971 | SUSPENSION FOR INJECTION | ||||||||
| 105966715 | 10596671 | 2 | SS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Parenteral | UNK | D | 202971 | SUSPENSION FOR INJECTION | ||||||||
| 105966715 | 10596671 | 3 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG | TABLET | ||||||
| 105966715 | 10596671 | 4 | SS | ABILIFY | ARIPIPRAZOLE | 1 | U | 0 | TABLET | ||||||||||
| 105966715 | 10596671 | 5 | SS | ZOPICLONE | ZOPICLONE | 1 | Oral | 7.5 MG, UNK | U | 0 | 7.5 | MG | |||||||
| 105966715 | 10596671 | 6 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 2.5 MG, UNK | 0 | 2.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105966715 | 10596671 | 1 | Patient restraint |
| 105966715 | 10596671 | 2 | Psychotic disorder |
| 105966715 | 10596671 | 3 | Patient restraint |
| 105966715 | 10596671 | 4 | Psychotic disorder |
| 105966715 | 10596671 | 5 | Insomnia |
| 105966715 | 10596671 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105966715 | 10596671 | LT |
| 105966715 | 10596671 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105966715 | 10596671 | Abdominal pain | |
| 105966715 | 10596671 | Abnormal weight gain | |
| 105966715 | 10596671 | Agitation | |
| 105966715 | 10596671 | Angina pectoris | |
| 105966715 | 10596671 | Anxiety | |
| 105966715 | 10596671 | Asthenia | |
| 105966715 | 10596671 | Back pain | |
| 105966715 | 10596671 | Body temperature abnormal | |
| 105966715 | 10596671 | Chest pain | |
| 105966715 | 10596671 | Cold-stimulus headache | |
| 105966715 | 10596671 | Decreased appetite | |
| 105966715 | 10596671 | Discomfort | |
| 105966715 | 10596671 | Dizziness | |
| 105966715 | 10596671 | Dry mouth | |
| 105966715 | 10596671 | General physical condition abnormal | |
| 105966715 | 10596671 | Headache | |
| 105966715 | 10596671 | Heart rate increased | |
| 105966715 | 10596671 | Heart rate irregular | |
| 105966715 | 10596671 | Hyperhidrosis | |
| 105966715 | 10596671 | Injection site pain | |
| 105966715 | 10596671 | Insomnia | |
| 105966715 | 10596671 | Limb discomfort | |
| 105966715 | 10596671 | Liver disorder | |
| 105966715 | 10596671 | Liver injury | |
| 105966715 | 10596671 | Muscle spasms | |
| 105966715 | 10596671 | Musculoskeletal stiffness | |
| 105966715 | 10596671 | Myalgia | |
| 105966715 | 10596671 | Nausea | |
| 105966715 | 10596671 | Off label use | |
| 105966715 | 10596671 | Overdose | |
| 105966715 | 10596671 | Palpitations | |
| 105966715 | 10596671 | Photopsia | |
| 105966715 | 10596671 | Restlessness | |
| 105966715 | 10596671 | Somnolence | |
| 105966715 | 10596671 | Suicidal ideation | |
| 105966715 | 10596671 | Tremor | |
| 105966715 | 10596671 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 105966715 | 10596671 | 1 | 20140903 | 20140903 | 0 | |
| 105966715 | 10596671 | 2 | 20140903 | 20141016 | 0 | |
| 105966715 | 10596671 | 3 | 20140905 | 0 |