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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126345002 | 12634500 | 2 | F | 2011 | 20160829 | 20160808 | 20160906 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-47138BP | BOEHRINGER INGELHEIM | 96.53 | YR | F | Y | 65.77000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126345002 | 12634500 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | ||||||
| 126345002 | 12634500 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | 18 MCG | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | ||||||
| 126345002 | 12634500 | 3 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | 50 MG | 0 | 50 | MG | QD | |||||||
| 126345002 | 12634500 | 4 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 2.5 MG | 0 | 2.5 | MG | QD | |||||||
| 126345002 | 12634500 | 5 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | 0.1 MG | 0 | .1 | MG | ||||||||
| 126345002 | 12634500 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 0 | 20 | MG | |||||||||
| 126345002 | 12634500 | 7 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | STRENGTH:0.25 MG | 0 | TABLET | |||||||||
| 126345002 | 12634500 | 8 | C | CENTRUM SILVER | MINERALSVITAMINS | 1 | Unknown | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126345002 | 12634500 | 9 | C | CALCIUM PLUS VITAMIN D3 | 2 | Unknown | 2400 MG | 0 | 1200 | MG | TABLET | BID | |||||||
| 126345002 | 12634500 | 10 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | Unknown | 300 MG | 0 | 300 | MG | CAPSULE | QD | ||||||
| 126345002 | 12634500 | 11 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | 250 MG | 0 | 250 | MG | QD | |||||||
| 126345002 | 12634500 | 12 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | 1000 MG | 0 | 1000 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126345002 | 12634500 | 1 | Chronic obstructive pulmonary disease |
| 126345002 | 12634500 | 3 | Hypertension |
| 126345002 | 12634500 | 4 | Product used for unknown indication |
| 126345002 | 12634500 | 5 | Product used for unknown indication |
| 126345002 | 12634500 | 6 | Product used for unknown indication |
| 126345002 | 12634500 | 7 | Product used for unknown indication |
| 126345002 | 12634500 | 8 | Product used for unknown indication |
| 126345002 | 12634500 | 9 | Product used for unknown indication |
| 126345002 | 12634500 | 10 | Product used for unknown indication |
| 126345002 | 12634500 | 11 | Product used for unknown indication |
| 126345002 | 12634500 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126345002 | 12634500 | Aphonia | |
| 126345002 | 12634500 | Dysphonia | |
| 126345002 | 12634500 | Incorrect route of drug administration | |
| 126345002 | 12634500 | Neck mass | |
| 126345002 | 12634500 | Tooth fracture |
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 |
|---|---|---|---|---|---|---|
| 126345002 | 12634500 | 1 | 2004 | 0 | ||
| 126345002 | 12634500 | 2 | 20160716 | 20160716 | 0 |