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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126794161 | 12679416 | 1 | I | 20160729 | 20160810 | 20160824 | 20160824 | EXP | GB-AUROBINDO-AUR-APL-2016-10449 | AUROBINDO | 23.00 | YR | F | Y | 65.50000 | KG | 20160824 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126794161 | 12679416 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, UNK | 78619 | 20 | MG | ||||||||
| 126794161 | 12679416 | 2 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 80 MG, UNK | U | 0 | 80 | MG | |||||||
| 126794161 | 12679416 | 3 | C | PHENYLEPHRINE HYDROCHLORIDE. | PHENYLEPHRINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 126794161 | 12679416 | 4 | C | LORATADINE. | LORATADINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126794161 | 12679416 | 1 | Depression |
| 126794161 | 12679416 | 2 | Product used for unknown indication |
| 126794161 | 12679416 | 3 | Product used for unknown indication |
| 126794161 | 12679416 | 4 | Hypersensitivity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126794161 | 12679416 | OT |
| 126794161 | 12679416 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126794161 | 12679416 | Constipation | |
| 126794161 | 12679416 | Decreased appetite | |
| 126794161 | 12679416 | Depressed mood | |
| 126794161 | 12679416 | Disturbance in attention | |
| 126794161 | 12679416 | Dizziness | |
| 126794161 | 12679416 | Dyspnoea | |
| 126794161 | 12679416 | Euphoric mood | |
| 126794161 | 12679416 | Fatigue | |
| 126794161 | 12679416 | Heart rate increased | |
| 126794161 | 12679416 | Hot flush | |
| 126794161 | 12679416 | Insomnia | |
| 126794161 | 12679416 | Malaise | |
| 126794161 | 12679416 | Nausea | |
| 126794161 | 12679416 | Palpitations | |
| 126794161 | 12679416 | Paraesthesia | |
| 126794161 | 12679416 | Psychiatric symptom | |
| 126794161 | 12679416 | Somnolence | |
| 126794161 | 12679416 | Suicidal ideation | |
| 126794161 | 12679416 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 126794161 | 12679416 | 1 | 20160729 | 0 |