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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419881 | 12541988 | 1 | I | 201602 | 20160627 | 20160708 | 20160708 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41765BP | BOEHRINGER INGELHEIM | 89.82 | YR | F | Y | 0.00000 | 20160708 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419881 | 12541988 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | ||||||
| 125419881 | 12541988 | 2 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 125419881 | 12541988 | 3 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 125419881 | 12541988 | 4 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | DOSE PER APPLICATION: 10 MG; FORMULATION: TABLET | 0 | QD | |||||||||
| 125419881 | 12541988 | 5 | C | POTASSIUM CHORIDE | 2 | Oral | 20 MEQ | 0 | 20 | MEQ | TABLET | QD | |||||||
| 125419881 | 12541988 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 5.7143 MG | 0 | 40 | MG | TABLET | /wk | ||||||
| 125419881 | 12541988 | 7 | C | LEVOTHRYOXINE | LEVOTHYROXINE | 1 | Oral | 0.075 MG | 0 | .075 | MG | TABLET | QD | ||||||
| 125419881 | 12541988 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 40 MG | 0 | 40 | MG | CAPSULE | QD | ||||||
| 125419881 | 12541988 | 9 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 125419881 | 12541988 | 10 | C | CALTRATE D3 | 2 | Oral | 600 MG | 0 | 600 | MG | TABLET | QD | |||||||
| 125419881 | 12541988 | 11 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 500 MG | 0 | 500 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125419881 | 12541988 | 1 | Asthma |
| 125419881 | 12541988 | 2 | Product used for unknown indication |
| 125419881 | 12541988 | 3 | Blood cholesterol increased |
| 125419881 | 12541988 | 4 | Product used for unknown indication |
| 125419881 | 12541988 | 5 | Muscle spasms |
| 125419881 | 12541988 | 6 | Fluid retention |
| 125419881 | 12541988 | 7 | Thyroid disorder |
| 125419881 | 12541988 | 8 | Product used for unknown indication |
| 125419881 | 12541988 | 9 | Anticoagulant therapy |
| 125419881 | 12541988 | 10 | Supplementation therapy |
| 125419881 | 12541988 | 11 | Supplementation therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125419881 | 12541988 | Dysphonia | |
| 125419881 | 12541988 | Off label use | |
| 125419881 | 12541988 | Throat tightness |
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 |
|---|---|---|---|---|---|---|
| 125419881 | 12541988 | 1 | 201602 | 0 |