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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127253221 | 12725322 | 1 | I | 201510 | 20160428 | 20160908 | 20160908 | PER | US-ENDO PHARMACEUTICALS INC.-2016-003012 | ENDO | 0.00 | M | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127253221 | 12725322 | 1 | PS | BENZTROPINE MESYLATE TABLETS 2MG | BENZTROPINE MESYLATE | 1 | Oral | U | 40715 | 2 | MG | TABLETS | BID | ||||||
| 127253221 | 12725322 | 2 | SS | HALDOL | HALOPERIDOL | 1 | Oral | U | 0 | TABLETS | BID | ||||||||
| 127253221 | 12725322 | 3 | C | LITHIUM. | LITHIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127253221 | 12725322 | 1 | Bipolar disorder |
| 127253221 | 12725322 | 2 | Product used for unknown indication |
| 127253221 | 12725322 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127253221 | 12725322 | Fatigue | |
| 127253221 | 12725322 | Grunting | |
| 127253221 | 12725322 | Lethargy | |
| 127253221 | 12725322 | Off label use | |
| 127253221 | 12725322 | Oromandibular dystonia | |
| 127253221 | 12725322 | Somnolence | |
| 127253221 | 12725322 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 127253221 | 12725322 | 1 | 201510 | 0 |