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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121350022 | 12135002 | 2 | F | 201502 | 20160906 | 20160301 | 20160915 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-08120BP | BOEHRINGER INGELHEIM | 56.73 | YR | F | Y | 89.81000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121350022 | 12135002 | 1 | PS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | DOSE PER APP: 20MCG/100MCG; DAILY DOSE: 80MCG/400MCG | Y | 403299,14L0005 | 21747 | PRESSURISED INHALATION | QID | ||||||
| 121350022 | 12135002 | 2 | C | LOVASTATIN. | LOVASTATIN | 1 | Unknown | 0 | |||||||||||
| 121350022 | 12135002 | 3 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 0 | |||||||||||
| 121350022 | 12135002 | 4 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 0 | |||||||||||
| 121350022 | 12135002 | 5 | C | CYMBALATA | 2 | Unknown | 0 | ||||||||||||
| 121350022 | 12135002 | 6 | C | RESTERIL | 2 | Unknown | 0 | ||||||||||||
| 121350022 | 12135002 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 121350022 | 12135002 | 8 | C | ANSID | 2 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121350022 | 12135002 | 1 | Asthma |
| 121350022 | 12135002 | 2 | Hypertension |
| 121350022 | 12135002 | 3 | Product used for unknown indication |
| 121350022 | 12135002 | 4 | Product used for unknown indication |
| 121350022 | 12135002 | 5 | Product used for unknown indication |
| 121350022 | 12135002 | 6 | Product used for unknown indication |
| 121350022 | 12135002 | 7 | Diabetes mellitus |
| 121350022 | 12135002 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121350022 | 12135002 | Drug ineffective | |
| 121350022 | 12135002 | Medication error | |
| 121350022 | 12135002 | Off label use | |
| 121350022 | 12135002 | 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 |
|---|---|---|---|---|---|---|
| 121350022 | 12135002 | 1 | 201502 | 201601 | 0 |