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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048241 | 12604824 | 1 | I | 2016 | 20160715 | 20160728 | 20160728 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-46813BP | BOEHRINGER INGELHEIM | 73.84 | YR | F | Y | 91.00000 | KG | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048241 | 12604824 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 7.5 MCG | 504410 | 21936 | 2.5 | UG | PRESSURISED INHALATION | TID | |||||
| 126048241 | 12604824 | 2 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126048241 | 12604824 | 3 | C | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 0 | PRESSURISED INHALATION | BID | |||||||||
| 126048241 | 12604824 | 4 | C | NABUMETONE. | NABUMETONE | 1 | Oral | 500 MG | 0 | 500 | MG | TABLET | QD | ||||||
| 126048241 | 12604824 | 5 | C | Baby Aspirin | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 126048241 | 12604824 | 6 | C | PEPCID | FAMOTIDINE | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126048241 | 12604824 | 7 | C | LORATADINE. | LORATADINE | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126048241 | 12604824 | 8 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | Unknown | 0 | BID | ||||||||||
| 126048241 | 12604824 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 2000 MCG | 0 | 2000 | UG | TABLET | QD | ||||||
| 126048241 | 12604824 | 10 | C | IMIQUIMOD. | IMIQUIMOD | 1 | Topical | DOSE PER APPLICATION: 5% | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126048241 | 12604824 | 1 | Chronic obstructive pulmonary disease |
| 126048241 | 12604824 | 2 | Thyroid disorder |
| 126048241 | 12604824 | 3 | Chronic obstructive pulmonary disease |
| 126048241 | 12604824 | 4 | Arthritis |
| 126048241 | 12604824 | 5 | Product used for unknown indication |
| 126048241 | 12604824 | 6 | Dyspepsia |
| 126048241 | 12604824 | 7 | Product used for unknown indication |
| 126048241 | 12604824 | 8 | Functional gastrointestinal disorder |
| 126048241 | 12604824 | 9 | Hair growth abnormal |
| 126048241 | 12604824 | 10 | Skin cancer |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126048241 | 12604824 | Incorrect dose administered | |
| 126048241 | 12604824 | Malaise | |
| 126048241 | 12604824 | Palpitations | |
| 126048241 | 12604824 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 126048241 | 12604824 | 1 | 201601 | 0 | ||
| 126048241 | 12604824 | 3 | 2009 | 0 |