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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125534053 | 12553405 | 3 | F | 201507 | 20160810 | 20160713 | 20160825 | EXP | JP-JNJFOC-20160708892 | JANSSEN | 49.40 | YR | A | F | Y | 53.00000 | KG | 20160825 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125534053 | 12553405 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | N | UNKNOWN | 20272 | 2 | MG | UNSPECIFIED | ||||||
| 125534053 | 12553405 | 2 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Intramuscular | 0 | 400 | MG | INJECTION | /month | |||||||
| 125534053 | 12553405 | 3 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | STRENGTH: 6 MG | 0 | 30 | MG | TABLET | QD | ||||||
| 125534053 | 12553405 | 4 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | STRENGTH: 12 MG | 0 | 2 | DF | TABLET | QD | ||||||
| 125534053 | 12553405 | 5 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Oral | STRENGTH: 12 MG AND 3 MG | 0 | 1 | DF | TABLET | QD | ||||||
| 125534053 | 12553405 | 6 | SS | LONASEN | BLONANSERIN | 1 | Oral | 0 | 4 | MG | UNSPECIFIED | QD | |||||||
| 125534053 | 12553405 | 7 | SS | LONASEN | BLONANSERIN | 1 | Oral | 0 | 16 | MG | UNSPECIFIED | QD | |||||||
| 125534053 | 12553405 | 8 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 9 | C | DAIOKANZOTO | LICORICE ROOT EXTRACTRHUBARB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 10 | C | LANDSEN | CLONAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 11 | C | HALCION | TRIAZOLAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 12 | C | DORAL | QUAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 13 | C | TEGRETOL | CARBAMAZEPINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 14 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 125534053 | 12553405 | 15 | C | GASCON | DIMETHICONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 16 | C | THYRADIN | LEVOTHYROXINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 17 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 0 | 500 | MG | UNSPECIFIED | ||||||||
| 125534053 | 12553405 | 18 | C | LEXOTAN | BROMAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 19 | C | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 20 | C | DEPAKINE | VALPROATE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 21 | C | AMOBAN | ZOPICLONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 22 | C | HIBERNA | PROMETHAZINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 23 | C | MUCOSOLVAN | AMBROXOL HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 24 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 25 | C | ROZEREM | RAMELTEON | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 26 | C | SILECE | FLUNITRAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 27 | C | SENNOSIDE A+B CALCIUM | SENNOSIDES A AND B | 1 | Unknown | 0 | |||||||||||
| 125534053 | 12553405 | 28 | C | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125534053 | 12553405 | 29 | C | RAMELTEON | RAMELTEON | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125534053 | 12553405 | 30 | C | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125534053 | 12553405 | 1 | Restlessness |
| 125534053 | 12553405 | 2 | Schizophrenia |
| 125534053 | 12553405 | 3 | Schizophrenia |
| 125534053 | 12553405 | 4 | Schizophrenia |
| 125534053 | 12553405 | 5 | Schizophrenia |
| 125534053 | 12553405 | 6 | Product used for unknown indication |
| 125534053 | 12553405 | 7 | Product used for unknown indication |
| 125534053 | 12553405 | 16 | Hypothyroidism |
| 125534053 | 12553405 | 17 | Feeling jittery |
| 125534053 | 12553405 | 19 | Akathisia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125534053 | 12553405 | DE |
| 125534053 | 12553405 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125534053 | 12553405 | Ileus paralytic | |
| 125534053 | 12553405 | Inappropriate schedule of drug administration | |
| 125534053 | 12553405 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125534053 | 12553405 | 1 | 201507 | 0 | ||
| 125534053 | 12553405 | 2 | 20150622 | 20150818 | 0 | |
| 125534053 | 12553405 | 3 | 201504 | 20150613 | 0 | |
| 125534053 | 12553405 | 4 | 2015 | 2015 | 0 | |
| 125534053 | 12553405 | 5 | 20150623 | 20150714 | 0 | |
| 125534053 | 12553405 | 6 | 20150623 | 20150707 | 0 | |
| 125534053 | 12553405 | 7 | 2015 | 20150622 | 0 | |
| 125534053 | 12553405 | 9 | 201504 | 0 | ||
| 125534053 | 12553405 | 10 | 201508 | 0 | ||
| 125534053 | 12553405 | 11 | 201504 | 0 | ||
| 125534053 | 12553405 | 12 | 201504 | 0 | ||
| 125534053 | 12553405 | 13 | 201504 | 0 | ||
| 125534053 | 12553405 | 14 | 201504 | 0 | ||
| 125534053 | 12553405 | 15 | 201504 | 0 | ||
| 125534053 | 12553405 | 16 | 201504 | 0 | ||
| 125534053 | 12553405 | 17 | 201504 | 0 | ||
| 125534053 | 12553405 | 18 | 201504 | 0 | ||
| 125534053 | 12553405 | 20 | 201508 | 0 | ||
| 125534053 | 12553405 | 21 | 201508 | 0 | ||
| 125534053 | 12553405 | 22 | 201504 | 0 | ||
| 125534053 | 12553405 | 23 | 201504 | 0 | ||
| 125534053 | 12553405 | 24 | 201508 | 0 | ||
| 125534053 | 12553405 | 27 | 201504 | 0 | ||
| 125534053 | 12553405 | 28 | 201504 | 20150616 | 0 | |
| 125534053 | 12553405 | 29 | 201504 | 0 |