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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127104541 | 12710454 | 1 | I | 20151103 | 20160902 | 20160902 | PER | OM-LUPIN PHARMACEUTICALS INC.-2015-03643 | LUPIN | NABHANI D, RABAH F, ELNOUR I, EL-NAGGARI M. AMLODIPINE DOUBLE-EDGED SWORD. PEDIATRIC NEPHROLOGY. 2015 SEP 09;30(1657):287. | 11.00 | YR | F | Y | 0.00000 | 20160902 | MD | OM | OM |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127104541 | 12710454 | 1 | PS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNKNOWN | 78043 | 5 | MG | QD | |||||||
| 127104541 | 12710454 | 2 | I | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127104541 | 12710454 | 3 | I | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127104541 | 12710454 | 4 | I | CYCLOSPORINE. | CYCLOSPORINE | 1 | UNKNOWN | 0 | |||||||||||
| 127104541 | 12710454 | 5 | I | Magnesium | MAGNESIUM | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 127104541 | 12710454 | 6 | I | Magnesium | MAGNESIUM | 1 | UNKNOWN | 0 | |||||||||||
| 127104541 | 12710454 | 7 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Unknown | 0 | 1.4 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127104541 | 12710454 | 1 | Hypertension |
| 127104541 | 12710454 | 2 | Product used for unknown indication |
| 127104541 | 12710454 | 3 | Product used for unknown indication |
| 127104541 | 12710454 | 4 | Renal impairment |
| 127104541 | 12710454 | 5 | Product used for unknown indication |
| 127104541 | 12710454 | 6 | Renal impairment |
| 127104541 | 12710454 | 7 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127104541 | 12710454 | Drug interaction | |
| 127104541 | 12710454 | Generalised oedema |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |