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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111158972 | 11115897 | 2 | F | 20141225 | 20160818 | 20150515 | 20160831 | EXP | US-APOTEX-2015AP008985 | APOTEX | 74.62 | YR | F | Y | 53.00000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111158972 | 11115897 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 2 DF, TID | Y | 75360 | 2 | DF | CAPSULE | TID | |||||
| 111158972 | 11115897 | 2 | SS | LYRICA | PREGABALIN | 1 | 75-100, TID | 0 | TID | ||||||||||
| 111158972 | 11115897 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | TWO IN THE MORNING AND 2 AT NIGHT | Y | U | 0 | 2 | DF | CAPSULE | BID | |||||
| 111158972 | 11115897 | 4 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | 40 MG, QD | U | U | 0 | 40 | MG | |||||||
| 111158972 | 11115897 | 5 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | 75 MG, UNK | U | U | 0 | 75 | MG | TABLET | ||||||
| 111158972 | 11115897 | 6 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 50 ?G, QD | U | U | 0 | 50 | UG | |||||||
| 111158972 | 11115897 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | 10 MG, DAILY | U | U | 0 | 10 | MG | |||||||
| 111158972 | 11115897 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 40 MG, Q.H.S. | U | U | 0 | 40 | MG | TABLET | QD | |||||
| 111158972 | 11115897 | 9 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0.5 MG, ONCE OR TWICE DAILY, AS NEEDED | U | U | 0 | .5 | MG | |||||||
| 111158972 | 11115897 | 10 | C | HYDROCODONE | HYDROCODONE | 1 | U | U | 0 | TABLET | |||||||||
| 111158972 | 11115897 | 11 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | 75 MG, QD | U | U | 0 | 75 | MG | |||||||
| 111158972 | 11115897 | 12 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | U | U | 0 | ||||||||||
| 111158972 | 11115897 | 13 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | U | 0 | ||||||||||
| 111158972 | 11115897 | 14 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | U | U | 0 | ||||||||||
| 111158972 | 11115897 | 15 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | USUALLY 2 A DAY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111158972 | 11115897 | 1 | Neuropathy peripheral |
| 111158972 | 11115897 | 2 | Neuropathy peripheral |
| 111158972 | 11115897 | 3 | Neuropathy peripheral |
| 111158972 | 11115897 | 4 | Depression |
| 111158972 | 11115897 | 5 | Peripheral arterial occlusive disease |
| 111158972 | 11115897 | 6 | Thyroid disorder |
| 111158972 | 11115897 | 7 | Blood pressure management |
| 111158972 | 11115897 | 8 | Blood cholesterol abnormal |
| 111158972 | 11115897 | 9 | Anxiety |
| 111158972 | 11115897 | 10 | Pain |
| 111158972 | 11115897 | 11 | Product used for unknown indication |
| 111158972 | 11115897 | 12 | Product used for unknown indication |
| 111158972 | 11115897 | 13 | Product used for unknown indication |
| 111158972 | 11115897 | 14 | Product used for unknown indication |
| 111158972 | 11115897 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111158972 | 11115897 | HO |
| 111158972 | 11115897 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111158972 | 11115897 | Drug ineffective | |
| 111158972 | 11115897 | Leg amputation | |
| 111158972 | 11115897 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 111158972 | 11115897 | 1 | 2006 | 0 | ||
| 111158972 | 11115897 | 2 | 2014 | 2015 | 0 |