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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125016642 | 12501664 | 2 | F | 201406 | 20160720 | 20160627 | 20160727 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-39980BP | BOEHRINGER INGELHEIM | 86.38 | YR | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125016642 | 12501664 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 507914A,15C3219 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 125016642 | 12501664 | 2 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 100 MG | 0 | 100 | MG | QD | |||||||
| 125016642 | 12501664 | 3 | C | citalapam | 2 | Oral | 20 MG | 0 | 20 | MG | QD | ||||||||
| 125016642 | 12501664 | 4 | C | levothyroxin | LEVOTHYROXINE | 1 | Oral | 75 MG | 0 | 75 | MG | QD | |||||||
| 125016642 | 12501664 | 5 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Oral | 60 MG | 0 | 60 | MG | QD | |||||||
| 125016642 | 12501664 | 6 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | QD | |||||||
| 125016642 | 12501664 | 7 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 10 MG | 0 | 10 | MG | QD | |||||||
| 125016642 | 12501664 | 8 | C | atorvastatin | ATORVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | QD | |||||||
| 125016642 | 12501664 | 9 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Oral | 30 MG | 0 | 10 | MG | TID | |||||||
| 125016642 | 12501664 | 10 | C | benzonate | BENZONATATE | 1 | Oral | 0 | 200 | MG | |||||||||
| 125016642 | 12501664 | 11 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION: 200MCG/5MCG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125016642 | 12501664 | 1 | Chronic obstructive pulmonary disease |
| 125016642 | 12501664 | 2 | Product used for unknown indication |
| 125016642 | 12501664 | 3 | Depression |
| 125016642 | 12501664 | 4 | Hypothyroidism |
| 125016642 | 12501664 | 5 | Hypertension |
| 125016642 | 12501664 | 6 | Product used for unknown indication |
| 125016642 | 12501664 | 7 | Hypertension |
| 125016642 | 12501664 | 8 | Blood cholesterol increased |
| 125016642 | 12501664 | 9 | Hypertension |
| 125016642 | 12501664 | 10 | Product used for unknown indication |
| 125016642 | 12501664 | 11 | Chronic obstructive pulmonary disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125016642 | 12501664 | OT |
| 125016642 | 12501664 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125016642 | 12501664 | Bronchitis | |
| 125016642 | 12501664 | Circulatory collapse | |
| 125016642 | 12501664 | Dependent personality disorder | |
| 125016642 | 12501664 | Dizziness | |
| 125016642 | 12501664 | Fall | |
| 125016642 | 12501664 | Fatigue | |
| 125016642 | 12501664 | Head injury | |
| 125016642 | 12501664 | Heart rate decreased | |
| 125016642 | 12501664 | Hypertension | |
| 125016642 | 12501664 | Hypotension | |
| 125016642 | 12501664 | Muscular weakness | |
| 125016642 | 12501664 | Nasopharyngitis | |
| 125016642 | 12501664 | Pneumonia | |
| 125016642 | 12501664 | Product physical issue | |
| 125016642 | 12501664 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 125016642 | 12501664 | 1 | 2008 | 0 | ||
| 125016642 | 12501664 | 2 | 2014 | 0 | ||
| 125016642 | 12501664 | 3 | 2006 | 0 | ||
| 125016642 | 12501664 | 7 | 2014 | 0 | ||
| 125016642 | 12501664 | 8 | 2000 | 0 | ||
| 125016642 | 12501664 | 9 | 201601 | 0 | ||
| 125016642 | 12501664 | 10 | 201601 | 0 | ||
| 125016642 | 12501664 | 11 | 201601 | 0 |