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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125588131 | 12558813 | 1 | I | 20160704 | 20160715 | 20160715 | EXP | US-UCBSA-2016026163 | UCB | GHANTA V, STRAUSS M, COLLAZO-MALDONADO R. LIFE THREATENING RHABDOMYOLYSIS FROM THE COMBINATION OF LEDIPASVIR/SOFOSBUVIR AND HIGH DOSE STATINS. AMERICAN JOURNAL OF KIDNEY DISEASES. 2016;67(5):A48 | 60.00 | YR | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125588131 | 12558813 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1000 MG DAILY DOSE | U | 21035 | ||||||||||
| 125588131 | 12558813 | 2 | SS | ATORVASTATIN CALCIUM. | ATORVASTATIN CALCIUM | 1 | 80 MG, ONCE DAILY (QD) | Y | 0 | 80 | MG | QD | |||||||
| 125588131 | 12558813 | 3 | C | Acetylsalicylic acid | ASPIRIN | 1 | 81 MG DAILY DOSE | U | 0 | ||||||||||
| 125588131 | 12558813 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | 800 MG, 3X/DAY (TID) | U | 0 | 800 | MG | TID | |||||||
| 125588131 | 12558813 | 5 | C | GABAPENTIN. | GABAPENTIN | 1 | 800 MG, 3X/DAY (TID) | U | 0 | 800 | MG | TID | |||||||
| 125588131 | 12558813 | 6 | C | GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDEMETFORMIN HYDROCHLORIDE | 1 | 5/500 2 TABLET TWICE DAILY | U | 0 | BID | |||||||||
| 125588131 | 12558813 | 7 | C | Lisinopril + hidroclorotiazida | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | 20/25 2 TABLETS DAILY | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125588131 | 12558813 | 1 | Product used for unknown indication |
| 125588131 | 12558813 | 2 | Product used for unknown indication |
| 125588131 | 12558813 | 3 | Product used for unknown indication |
| 125588131 | 12558813 | 4 | Product used for unknown indication |
| 125588131 | 12558813 | 5 | Product used for unknown indication |
| 125588131 | 12558813 | 6 | Product used for unknown indication |
| 125588131 | 12558813 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125588131 | 12558813 | OT |
| 125588131 | 12558813 | HO |
| 125588131 | 12558813 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125588131 | 12558813 | Acute kidney injury | |
| 125588131 | 12558813 | Leukocytosis | |
| 125588131 | 12558813 | Rhabdomyolysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |