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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048272 | 12604827 | 2 | F | 2013 | 20160815 | 20160728 | 20160826 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-47460BP | BOEHRINGER INGELHEIM | 58.89 | YR | M | Y | 0.00000 | 20160827 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048272 | 12604827 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 507710A,14C3232 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 126048272 | 12604827 | 2 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 126048272 | 12604827 | 3 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 150 MG | 0 | 150 | MG | TABLET | QD | ||||||
| 126048272 | 12604827 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | STRENGTH:5 MG EVERY OTHER DAY AND 7.5 MG ON OPPOSITE DAYS | 0 | TABLET | |||||||||
| 126048272 | 12604827 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | FORMULATION: TABLET | 0 | ||||||||||
| 126048272 | 12604827 | 6 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 126048272 | 12604827 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 2 ANZ | 0 | NEBULISER LIQUID | BID | ||||||||
| 126048272 | 12604827 | 8 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 126048272 | 12604827 | 9 | C | OXYMORPHONE | OXYMORPHONE | 1 | Oral | 80 MG | 0 | 40 | MG | TABLET | BID | ||||||
| 126048272 | 12604827 | 10 | C | OXYMORPHONE | OXYMORPHONE | 1 | Oral | 40 MG | 0 | 10 | MG | TABLET | |||||||
| 126048272 | 12604827 | 11 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 3 ANZ | 0 | ORAL SOLUTION | TID | ||||||||
| 126048272 | 12604827 | 12 | C | INDOCIN | INDOMETHACININDOMETHACIN SODIUM | 1 | Oral | 50 MG | 0 | 25 | MG | CAPSULE | |||||||
| 126048272 | 12604827 | 13 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 30 MG | 0 | 10 | MG | TABLET | |||||||
| 126048272 | 12604827 | 14 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 126048272 | 12604827 | 15 | C | OXYGEN. | OXYGEN | 1 | Unknown | DOSE PER APPLICATION: 4 LITERS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126048272 | 12604827 | 1 | Chronic obstructive pulmonary disease |
| 126048272 | 12604827 | 2 | Depression |
| 126048272 | 12604827 | 3 | Depression |
| 126048272 | 12604827 | 4 | Sarcoidosis |
| 126048272 | 12604827 | 6 | Hypertension |
| 126048272 | 12604827 | 7 | Sarcoidosis |
| 126048272 | 12604827 | 8 | Chronic obstructive pulmonary disease |
| 126048272 | 12604827 | 9 | Arthralgia |
| 126048272 | 12604827 | 10 | Back pain |
| 126048272 | 12604827 | 11 | Product used for unknown indication |
| 126048272 | 12604827 | 12 | Gout |
| 126048272 | 12604827 | 13 | Product used for unknown indication |
| 126048272 | 12604827 | 14 | Sleep disorder |
| 126048272 | 12604827 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126048272 | 12604827 | Fall | |
| 126048272 | 12604827 | Head injury | |
| 126048272 | 12604827 | Laceration | |
| 126048272 | 12604827 | Mouth injury | |
| 126048272 | 12604827 | Muscular weakness | |
| 126048272 | 12604827 | Oral contusion | |
| 126048272 | 12604827 | Product quality issue | |
| 126048272 | 12604827 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 126048272 | 12604827 | 1 | 2010 | 0 | ||
| 126048272 | 12604827 | 7 | 201607 | 0 |