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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127605891 | 12760589 | 1 | I | 201304 | 20160127 | 20160919 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2016-001101 | ENDO | 76.33 | YR | M | Y | 0.00000 | 20160919 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127605891 | 12760589 | 1 | PS | AMITRIPTYLINE HCL 10MG | AMITRIPTYLINE | 1 | Unknown | Y | 40218 | 10 | MG | UNKNOWN | |||||||
| 127605891 | 12760589 | 2 | SS | PRIMIDONE TABLETS 50MG | PRIMIDONE | 1 | Unknown | Y | 40586 | 50 | MG | UNKNOWN | |||||||
| 127605891 | 12760589 | 3 | SS | LYRICA | PREGABALIN | 1 | Unknown | Y | 0 | 100 | MG | UNKNOWN | |||||||
| 127605891 | 12760589 | 4 | SS | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | Unknown | Y | 0 | 12 | MG | TABLETS | BID | ||||||
| 127605891 | 12760589 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | Y | 0 | 300 | MG | CAPSULE | TID | ||||||
| 127605891 | 12760589 | 6 | SS | CILOSTAZOL. | CILOSTAZOL | 1 | Unknown | Y | 0 | 100 | MG | TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127605891 | 12760589 | 1 | Diabetic neuropathy |
| 127605891 | 12760589 | 2 | Diabetic neuropathy |
| 127605891 | 12760589 | 3 | Diabetic neuropathy |
| 127605891 | 12760589 | 4 | Diabetic neuropathy |
| 127605891 | 12760589 | 5 | Diabetic neuropathy |
| 127605891 | 12760589 | 6 | Diabetic neuropathy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127605891 | 12760589 | Dizziness | |
| 127605891 | 12760589 | Drug ineffective for unapproved indication | |
| 127605891 | 12760589 | Fluid retention | |
| 127605891 | 12760589 | Malaise | |
| 127605891 | 12760589 | Off label use | |
| 127605891 | 12760589 | Sluggishness | |
| 127605891 | 12760589 | Vision blurred |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127605891 | 12760589 | 1 | 201304 | 0 | ||
| 127605891 | 12760589 | 2 | 201508 | 201508 | 0 | |
| 127605891 | 12760589 | 3 | 201510 | 201510 | 0 | |
| 127605891 | 12760589 | 4 | 201506 | 201506 | 0 | |
| 127605891 | 12760589 | 5 | 201503 | 201503 | 0 | |
| 127605891 | 12760589 | 6 | 201408 | 201408 | 0 |