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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127748062 | 12774806 | 2 | F | 20160912 | 20160923 | 20160927 | EXP | ES-APOTEX-2016AP011958 | APOTEX | DEZA G, GARCIA-COLMENERO L, CURTO-BARREDO L, PUJOL RM, GIMENEZ-ARNAU AM.. MANAGEMENT OF CHRONIC SPONTANEOUS URTICARIA EXACERBATED BY ANTIHISTAMINES: WHEN TREATMENT CAN ACT AS A CAUSAL AGENT ITSELF.. ACTA-DERM-VENEREOL. 2016;96(6):838-839. | 35.00 | YR | F | Y | 0.00000 | 20160927 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127748062 | 12774806 | 1 | PS | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | U | U | 78317 | |||||||||
| 127748062 | 12774806 | 2 | SS | LEVOCETIRIZINA KIRON COMPRIMIDOS RECUBIERTOS CON PELICULA | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | U | U | 0 | TABLET | ||||||||
| 127748062 | 12774806 | 3 | SS | EBASTINA APOTEX COMPRIMIDOS | EBASTINE | 1 | Oral | U | U | 0 | TABLET | ||||||||
| 127748062 | 12774806 | 4 | SS | DEXCHLORPHENIRAMINE | DEXCHLORPHENIRAMINE | 1 | Oral | U | U | 0 | |||||||||
| 127748062 | 12774806 | 5 | SS | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | U | U | 0 | |||||||||
| 127748062 | 12774806 | 6 | SS | LORATADINE. | LORATADINE | 1 | Oral | U | U | 0 | |||||||||
| 127748062 | 12774806 | 7 | SS | CYPROHEPTADINE. | CYPROHEPTADINE | 1 | Oral | U | U | 0 | |||||||||
| 127748062 | 12774806 | 8 | SS | RUPATADINE | RUPATADINE | 1 | Oral | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127748062 | 12774806 | 1 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 2 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 3 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 4 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 5 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 6 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 7 | Chronic spontaneous urticaria |
| 127748062 | 12774806 | 8 | Chronic spontaneous urticaria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127748062 | 12774806 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127748062 | 12774806 | Chronic spontaneous urticaria | |
| 127748062 | 12774806 | Condition aggravated | |
| 127748062 | 12774806 | Drug ineffective | |
| 127748062 | 12774806 | Type I hypersensitivity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |