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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127614571 | 12761457 | 1 | I | 20160908 | 20160920 | 20160920 | EXP | US-MACLEODS PHARMACEUTICALS US LTD-MAC2016003128 | MACLEODS | 0.00 | Y | 0.00000 | 20160920 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127614571 | 12761457 | 1 | PS | PRAMIPEXOLE. | PRAMIPEXOLE | 1 | Unknown | 0.125 MG, QD, AT BEDTIME | U | 0 | .125 | MG | |||||||
| 127614571 | 12761457 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG, BID | U | 0 | .5 | MG | |||||||
| 127614571 | 12761457 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 0.5 MG, Q.A.M. | U | 0 | .5 | MG | |||||||
| 127614571 | 12761457 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 1 MG, AT BED TIME | U | 0 | 1 | MG | |||||||
| 127614571 | 12761457 | 5 | SS | METHYLPHENIDATE HYDROCHLORIDE. | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | 36 MG, Q.A.M. | U | 0 | 36 | MG | |||||||
| 127614571 | 12761457 | 6 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 40 MG, Q.A.M. | U | 0 | 40 | MG | |||||||
| 127614571 | 12761457 | 7 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 375 MG Q.A.M. | U | 0 | 375 | MG | |||||||
| 127614571 | 12761457 | 8 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 500 MG, QD AT BEDTIME | U | 0 | 500 | MG | |||||||
| 127614571 | 12761457 | 9 | C | Melatonin | MELATONIN | 1 | Unknown | 5 MG, QD, AT BEDTIME AS NEEDED | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127614571 | 12761457 | 1 | Product used for unknown indication |
| 127614571 | 12761457 | 2 | Product used for unknown indication |
| 127614571 | 12761457 | 5 | Product used for unknown indication |
| 127614571 | 12761457 | 6 | Product used for unknown indication |
| 127614571 | 12761457 | 7 | Product used for unknown indication |
| 127614571 | 12761457 | 9 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127614571 | 12761457 | OT |
| 127614571 | 12761457 | LT |
| 127614571 | 12761457 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127614571 | 12761457 | Agitation | |
| 127614571 | 12761457 | Aphasia | |
| 127614571 | 12761457 | Chills | |
| 127614571 | 12761457 | Confusional state | |
| 127614571 | 12761457 | Decerebrate posture | |
| 127614571 | 12761457 | Disorientation | |
| 127614571 | 12761457 | Drug administered to patient of inappropriate age | |
| 127614571 | 12761457 | Dysarthria | |
| 127614571 | 12761457 | Dyskinesia | |
| 127614571 | 12761457 | Dysphagia | |
| 127614571 | 12761457 | Gait disturbance | |
| 127614571 | 12761457 | Hyperhidrosis | |
| 127614571 | 12761457 | Mental status changes | |
| 127614571 | 12761457 | Muscle rigidity | |
| 127614571 | 12761457 | Myoclonus | |
| 127614571 | 12761457 | Neuroleptic malignant syndrome | |
| 127614571 | 12761457 | Opisthotonus | |
| 127614571 | 12761457 | Salivary hypersecretion | |
| 127614571 | 12761457 | Somnolence | |
| 127614571 | 12761457 | Tachycardia | |
| 127614571 | 12761457 | Tachypnoea | |
| 127614571 | 12761457 | Tremor | |
| 127614571 | 12761457 | Unresponsive to stimuli |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |