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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126713011 | 12671301 | 1 | I | 20160414 | 20160822 | 20160822 | PER | US-TEVA-654370USA | TEVA | 0.00 | F | Y | 56.69000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126713011 | 12671301 | 1 | PS | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Oral | HS PRN | Y | 4DR0217 (26F977) | 76191 | 180 | MG | TABLET | |||||
| 126713011 | 12671301 | 2 | SS | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Oral | 1/2 TAB HS PRN REGIMEN 2 | Y | 4DR0217 (26F977) | 76191 | 180 | MG | TABLET | |||||
| 126713011 | 12671301 | 3 | SS | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Oral | 1/2 TAB HS PRN REGIMEN 2 | Y | 4DR0217 (26F977) | 76191 | 180 | MG | TABLET | |||||
| 126713011 | 12671301 | 4 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126713011 | 12671301 | 1 | Sneezing |
| 126713011 | 12671301 | 2 | Nasal congestion |
| 126713011 | 12671301 | 4 | Hypothyroidism |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126713011 | 12671301 | Expired product administered | |
| 126713011 | 12671301 | Insomnia | Insomnia |
| 126713011 | 12671301 | Mucosal dryness | Mucosal dryness |
| 126713011 | 12671301 | Off label use | |
| 126713011 | 12671301 | Thirst | |
| 126713011 | 12671301 | Underdose | |
| 126713011 | 12671301 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126713011 | 12671301 | 1 | 201601 | 201601 | 0 | |
| 126713011 | 12671301 | 2 | 201601 | 201602 | 0 | |
| 126713011 | 12671301 | 3 | 20160410 | 0 |