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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126187003 | 12618700 | 3 | F | 201607 | 20160824 | 20160803 | 20160829 | EXP | US-OTSUKA-2016_017091 | OTSUKA | 23.99 | YR | M | Y | 208.00000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126187003 | 12618700 | 1 | PS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, MONTHLY | U | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | |||||
| 126187003 | 12618700 | 2 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 3 | C | MAALOX ANTACID | ALUMINUM HYDROXIDEDIMETHICONEMAGNESIUM HYDROXIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 4 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | Unknown | 2 DF, Q4HR | 0 | 2 | DF | Q4H | |||||||
| 126187003 | 12618700 | 5 | C | BENZTROPINE MESYLATE. | BENZTROPINE MESYLATE | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 0.5 MG, Q8 | 0 | .5 | MG | TABLET | |||||||
| 126187003 | 12618700 | 7 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 25 MG, Q5H PRN | 0 | 25 | MG | ||||||||
| 126187003 | 12618700 | 8 | C | DIVALPROEX SODIUM. | DIVALPROEX SODIUM | 1 | Oral | 500 MG, QAMS | 0 | 500 | MG | TABLET | |||||||
| 126187003 | 12618700 | 9 | C | HALOPERIDOL LACTATE. | HALOPERIDOL LACTATE | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 10 | C | HYDROXYZINE PAMOATE. | HYDROXYZINE PAMOATE | 1 | Oral | 25 MG, Q4HR PRN | 0 | 25 | MG | Q4H | |||||||
| 126187003 | 12618700 | 11 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 2 MG, Q4HR PRN | 0 | 2 | MG | Q4H | |||||||
| 126187003 | 12618700 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Intramuscular | 2 MG, Q4HR | 0 | 2 | MG | Q4H | |||||||
| 126187003 | 12618700 | 13 | C | MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | 1 | Oral | 30 ML, BED TIME PRN | 0 | 30 | ML | ||||||||
| 126187003 | 12618700 | 14 | C | HYDROCERIN | 2 | Unknown | UNK | 0 | |||||||||||
| 126187003 | 12618700 | 15 | C | NICOTINE. | NICOTINE | 1 | Oral | 2 MG, Q4H PRN | 0 | 2 | MG | ||||||||
| 126187003 | 12618700 | 16 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, DAILY | 0 | 20 | MG | TABLET | QD | ||||||
| 126187003 | 12618700 | 17 | C | RISPERIDONE. | RISPERIDONE | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 18 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Unknown | UNK | 0 | ||||||||||
| 126187003 | 12618700 | 19 | C | TRIAMCINOLONE ACETONIDE. | TRIAMCINOLONE ACETONIDE | 1 | Topical | 1 APPLIC, BID | 0 | BID | |||||||||
| 126187003 | 12618700 | 20 | C | PALIPERIDONE. | PALIPERIDONE | 1 | Intramuscular | 155 MG, ONCE | 0 | 155 | MG | ||||||||
| 126187003 | 12618700 | 21 | C | ALUMINIUM HYDROXIDE W/MAGNESIUM HYDROXIDE | ALUMINUM HYDROXIDEMAGNESIUM HYDROXIDE | 1 | Oral | 30 ML, Q4HR PRN | 0 | 30 | ML | Q4H | |||||||
| 126187003 | 12618700 | 22 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, Q4HR PRN | 0 | 650 | MG | Q4H | |||||||
| 126187003 | 12618700 | 23 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | Unknown | 2 DF, Q4HR PRN | 0 | 2 | DF | Q4H | |||||||
| 126187003 | 12618700 | 24 | C | MINERAL OIL W/PETROLATUM | 2 | Topical | 1 APPLIC BID PRN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126187003 | 12618700 | 1 | Schizophrenia |
| 126187003 | 12618700 | 2 | Product used for unknown indication |
| 126187003 | 12618700 | 3 | Product used for unknown indication |
| 126187003 | 12618700 | 4 | Product used for unknown indication |
| 126187003 | 12618700 | 5 | Product used for unknown indication |
| 126187003 | 12618700 | 6 | Product used for unknown indication |
| 126187003 | 12618700 | 7 | Product used for unknown indication |
| 126187003 | 12618700 | 8 | Product used for unknown indication |
| 126187003 | 12618700 | 9 | Product used for unknown indication |
| 126187003 | 12618700 | 10 | Anxiety |
| 126187003 | 12618700 | 11 | Anxiety |
| 126187003 | 12618700 | 13 | Constipation |
| 126187003 | 12618700 | 14 | Product used for unknown indication |
| 126187003 | 12618700 | 15 | Product used for unknown indication |
| 126187003 | 12618700 | 16 | Product used for unknown indication |
| 126187003 | 12618700 | 17 | Product used for unknown indication |
| 126187003 | 12618700 | 18 | Product used for unknown indication |
| 126187003 | 12618700 | 19 | Product used for unknown indication |
| 126187003 | 12618700 | 20 | Psychotic disorder |
| 126187003 | 12618700 | 21 | Dyspepsia |
| 126187003 | 12618700 | 22 | Pain |
| 126187003 | 12618700 | 23 | Asthma |
| 126187003 | 12618700 | 24 | Dry skin |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126187003 | 12618700 | HO |
| 126187003 | 12618700 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126187003 | 12618700 | Agitation | |
| 126187003 | 12618700 | Asthenia | |
| 126187003 | 12618700 | Decreased appetite | |
| 126187003 | 12618700 | Delusion of grandeur | |
| 126187003 | 12618700 | Depression | |
| 126187003 | 12618700 | Disturbance in attention | |
| 126187003 | 12618700 | Hallucinations, mixed | |
| 126187003 | 12618700 | Homicidal ideation | |
| 126187003 | 12618700 | Insomnia | |
| 126187003 | 12618700 | Mental disorder | |
| 126187003 | 12618700 | Suicidal ideation | |
| 126187003 | 12618700 | Tachyphrenia |
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 |
|---|---|---|---|---|---|---|
| 126187003 | 12618700 | 1 | 20160701 | 0 | ||
| 126187003 | 12618700 | 6 | 20160704 | 20160711 | 0 | |
| 126187003 | 12618700 | 7 | 20160705 | 20160710 | 0 | |
| 126187003 | 12618700 | 8 | 20160704 | 20160711 | 0 | |
| 126187003 | 12618700 | 10 | 20160704 | 20160705 | 0 | |
| 126187003 | 12618700 | 11 | 20160704 | 20160704 | 0 | |
| 126187003 | 12618700 | 12 | 20160704 | 20160704 | 0 | |
| 126187003 | 12618700 | 13 | 20160704 | 0 | ||
| 126187003 | 12618700 | 15 | 20160704 | 20160711 | 0 | |
| 126187003 | 12618700 | 16 | 20160705 | 20160711 | 0 | |
| 126187003 | 12618700 | 19 | 20160705 | 20160711 | 0 | |
| 126187003 | 12618700 | 20 | 20160713 | 20160713 | 0 | |
| 126187003 | 12618700 | 21 | 20160704 | 0 |