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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508562 | 12550856 | 2 | F | 20160630 | 20160712 | 20160714 | EXP | ES-JNJFOC-20160706014 | JOHNSON AND JOHNSON | MARTINEZ-LOPEZ A, ALVAREZ BLANCO O, LUQUE DE PABLOS A, MORALES SAN-JOSE M, RODRIGUEZ SANCHEZ DE LA BLANCA A. IBUPROFEN-INDUCED ACUTE INTERSTITIAL NEPHRITIS IN THE PAEDIATRIC POPULATION. NEFROLOGIA 2016;36(1):69 TO 71. | 4.00 | YR | C | M | Y | 17.00000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125508562 | 12550856 | 1 | PS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | Y | N | 19012 | UNSPECIFIED | ||||||||
| 125508562 | 12550856 | 2 | SS | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 5 MG/KG/8 H | Y | N | 19012 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125508562 | 12550856 | 2 | Urethral repair |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125508562 | 12550856 | HO |
| 125508562 | 12550856 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125508562 | 12550856 | Off label use | |
| 125508562 | 12550856 | Product use issue | |
| 125508562 | 12550856 | Tubulointerstitial nephritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |