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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126503131 | 12650313 | 1 | I | 20150921 | 20160722 | 20160814 | 20160814 | PER | US-ENDO PHARMACEUTICALS INC.-2016-004711 | ENDO | 47.04 | YR | F | Y | 0.00000 | 20160814 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126503131 | 12650313 | 1 | PS | MONTELUKAST SODIUM CHEWABLE TABLETS | MONTELUKAST SODIUM | 1 | Unknown | 91588 | UNKNOWN | ||||||||||
| 126503131 | 12650313 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 126503131 | 12650313 | 3 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 0 | 75 | MG | TABLETS | BID | |||||||
| 126503131 | 12650313 | 4 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126503131 | 12650313 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | ||||||||||||
| 126503131 | 12650313 | 6 | C | LEVOCETIRIZINE | LEVOCETIRIZINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126503131 | 12650313 | 1 | Seasonal allergy |
| 126503131 | 12650313 | 2 | Affective disorder |
| 126503131 | 12650313 | 3 | Bipolar disorder |
| 126503131 | 12650313 | 4 | Depression |
| 126503131 | 12650313 | 5 | Thyroidectomy |
| 126503131 | 12650313 | 6 | Seasonal allergy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126503131 | 12650313 | Diarrhoea | |
| 126503131 | 12650313 | Feeling abnormal | |
| 126503131 | 12650313 | Headache | |
| 126503131 | 12650313 | Hypersensitivity | |
| 126503131 | 12650313 | Muscle spasms | |
| 126503131 | 12650313 | Nausea | |
| 126503131 | 12650313 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 126503131 | 12650313 | 2 | 201503 | 0 | ||
| 126503131 | 12650313 | 3 | 20150921 | 0 |