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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126448951 | 12644895 | 1 | I | 201504 | 20160115 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2016-000450 | ENDO | 73.17 | YR | F | Y | 67.19000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126448951 | 12644895 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | 40256 | UNKNOWN | BID | |||||||||
| 126448951 | 12644895 | 2 | SS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | 40256 | UNKNOWN | ||||||||||
| 126448951 | 12644895 | 3 | SS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | 40256 | UNKNOWN | ||||||||||
| 126448951 | 12644895 | 4 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 500 | MG | TABLETS | BID | |||||||
| 126448951 | 12644895 | 5 | SS | LYRICA | PREGABALIN | 1 | Oral | 0 | 200 | MG | UNKNOWN | BID | |||||||
| 126448951 | 12644895 | 6 | SS | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 126448951 | 12644895 | 7 | C | HUMULIN NOS | INSULIN HUMAN | 1 | Unknown | 24 CC IN THE MORNING 22 CC AT NIGHT/BEFORE MEALS | 0 | INJECTION | BID | ||||||||
| 126448951 | 12644895 | 8 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | CAPSULE | QD | |||||||||
| 126448951 | 12644895 | 9 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 0 | 40 | MG | TABLETS | QD | |||||||
| 126448951 | 12644895 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 2400 UNITS | 0 | UNKNOWN | |||||||||
| 126448951 | 12644895 | 11 | C | CALCIUM + D | CALCIUMVITAMIN D | 1 | Oral | 600 UNITS | 0 | UNKNOWN | |||||||||
| 126448951 | 12644895 | 12 | C | BACTRIM DS/SEPTRA DS | 2 | Oral | 800-160 MG | 0 | TABLETS | TIW | |||||||||
| 126448951 | 12644895 | 13 | C | LIDOCAINE. | LIDOCAINE | 1 | Topical | 0 | CREAM | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126448951 | 12644895 | 1 | Pain in extremity |
| 126448951 | 12644895 | 2 | Muscular weakness |
| 126448951 | 12644895 | 4 | Diabetes mellitus |
| 126448951 | 12644895 | 5 | Neuralgia |
| 126448951 | 12644895 | 6 | Peripheral sensory neuropathy |
| 126448951 | 12644895 | 7 | Diabetes mellitus |
| 126448951 | 12644895 | 8 | Prophylaxis |
| 126448951 | 12644895 | 9 | Hypertension |
| 126448951 | 12644895 | 10 | Product used for unknown indication |
| 126448951 | 12644895 | 11 | Supplementation therapy |
| 126448951 | 12644895 | 12 | Product used for unknown indication |
| 126448951 | 12644895 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126448951 | 12644895 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126448951 | 12644895 | Abdominal distension | |
| 126448951 | 12644895 | Diabetes mellitus | |
| 126448951 | 12644895 | Dysphagia | |
| 126448951 | 12644895 | Dysphonia | |
| 126448951 | 12644895 | Gait disturbance | |
| 126448951 | 12644895 | Local swelling | |
| 126448951 | 12644895 | Myalgia | |
| 126448951 | 12644895 | Pain | |
| 126448951 | 12644895 | Peripheral swelling | |
| 126448951 | 12644895 | Swelling face | |
| 126448951 | 12644895 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 126448951 | 12644895 | 1 | 201504 | 0 | ||
| 126448951 | 12644895 | 2 | 2015 | 0 | ||
| 126448951 | 12644895 | 3 | 2005 | 0 | ||
| 126448951 | 12644895 | 5 | 20151127 | 0 | ||
| 126448951 | 12644895 | 7 | 201505 | 0 |