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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414123 | 12541412 | 3 | F | 20160704 | 20160708 | 20160718 | EXP | US-JNJFOC-20160700725 | JOHNSON AND JOHNSON | WILLIAMS K, DELEON S. COUGH AND LIP SLOUGH: THE SEARCH FOR A UNIFYING DIAGNOSIS. PEDIATRICS IN REVIEW JUN-2016;37 (6):P.E22-E24. | 7.00 | YR | C | M | Y | 0.00000 | 20160718 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125414123 | 12541412 | 1 | PS | CETIRIZINE HYDROCHLORIDE. | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | UNKNOWN | ||||||||
| 125414123 | 12541412 | 2 | SS | CETIRIZINE HYDROCHLORIDE. | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | U | 19835 | UNKNOWN | ||||||||
| 125414123 | 12541412 | 3 | SS | DIPHENHYDRAMINE HYDROCHLORIDE. | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 999999 | UNSPECIFIED | ||||||||
| 125414123 | 12541412 | 4 | SS | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | AS NEEDED | U | 0 | UNSPECIFIED | ||||||||
| 125414123 | 12541412 | 5 | SS | ALUMINIUM HYDROXIDE W/MAGNESIUM HYDROXIDE | ALUMINUM HYDROXIDEMAGNESIUM HYDROXIDE | 1 | Unknown | AS NEEDED | U | 0 | UNSPECIFIED | ||||||||
| 125414123 | 12541412 | 6 | SS | LIDOCAINE. | LIDOCAINE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125414123 | 12541412 | 2 | Respiratory symptom |
| 125414123 | 12541412 | 3 | Oral pain |
| 125414123 | 12541412 | 4 | Respiratory symptom |
| 125414123 | 12541412 | 5 | Oral pain |
| 125414123 | 12541412 | 6 | Oral pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125414123 | 12541412 | HO |
| 125414123 | 12541412 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125414123 | 12541412 | Conjunctivitis | |
| 125414123 | 12541412 | Drooling | |
| 125414123 | 12541412 | Drug ineffective for unapproved indication | |
| 125414123 | 12541412 | Face oedema | |
| 125414123 | 12541412 | Hypoaesthesia oral | |
| 125414123 | 12541412 | Hypoxia | |
| 125414123 | 12541412 | Lip exfoliation | |
| 125414123 | 12541412 | Lip swelling | |
| 125414123 | 12541412 | Mucosal inflammation | |
| 125414123 | 12541412 | Mycoplasma infection | |
| 125414123 | 12541412 | Off label use | |
| 125414123 | 12541412 | Oral pain | |
| 125414123 | 12541412 | Pneumonia mycoplasmal | |
| 125414123 | 12541412 | Post-tussive vomiting | |
| 125414123 | 12541412 | Rash maculo-papular | |
| 125414123 | 12541412 | Tongue ulceration | |
| 125414123 | 12541412 | Urethritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |