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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449881 | 12544988 | 1 | I | 20160629 | 20160711 | 20160711 | PER | US-TAKEDA-2016TUS011567 | TAKEDA | 0.00 | M | Y | 90.70000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449881 | 12544988 | 1 | PS | ROZEREM | RAMELTEON | 1 | Oral | 8 MG, QD | 21782 | 8 | MG | QD | |||||||
| 125449881 | 12544988 | 2 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 150 MG, UNK | U | 0 | 150 | MG | |||||||
| 125449881 | 12544988 | 3 | C | OLANZAPINE. | OLANZAPINE | 1 | Oral | 15 MG, UNK | U | 0 | 15 | MG | |||||||
| 125449881 | 12544988 | 4 | C | DIVALPROEX | DIVALPROEX SODIUM | 1 | Oral | 100 MG, UNK | U | 0 | 100 | MG | |||||||
| 125449881 | 12544988 | 5 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | Respiratory (inhalation) | UNK | U | 0 | |||||||||
| 125449881 | 12544988 | 6 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 125449881 | 12544988 | 7 | C | BUPROPION. | BUPROPION | 1 | Oral | 200 MG, UNK | U | 0 | 200 | MG | |||||||
| 125449881 | 12544988 | 8 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0.025 ?G, UNK | U | 0 | .025 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125449881 | 12544988 | 1 | Insomnia |
| 125449881 | 12544988 | 2 | Bipolar disorder |
| 125449881 | 12544988 | 3 | Bipolar disorder |
| 125449881 | 12544988 | 4 | Bipolar disorder |
| 125449881 | 12544988 | 5 | Asthma |
| 125449881 | 12544988 | 6 | Depression |
| 125449881 | 12544988 | 7 | Depression |
| 125449881 | 12544988 | 8 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125449881 | 12544988 | Diplopia | |
| 125449881 | 12544988 | Fatigue | |
| 125449881 | 12544988 | Headache | |
| 125449881 | 12544988 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 125449881 | 12544988 | 1 | 20160628 | 0 |