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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124901653 | 12490165 | 3 | F | 201511 | 20160811 | 20160622 | 20160818 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-38470BP | BOEHRINGER INGELHEIM | 57.56 | YR | M | Y | 107.50000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124901653 | 12490165 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | Y | 504280A,15C3208 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | ||||
| 124901653 | 12490165 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 36 MCG | Y | 504280A,15C3208 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | BID | ||||
| 124901653 | 12490165 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 2400 MG | Y | 0 | 1200 | MG | BID | ||||||
| 124901653 | 12490165 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 3 MG | 0 | 1 | MG | TABLET | TID | ||||||
| 124901653 | 12490165 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | ||||||||||||
| 124901653 | 12490165 | 6 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 37.5 MG | 0 | 37.5 | MG | TABLET | QD | ||||||
| 124901653 | 12490165 | 7 | C | LOVASTATIN. | LOVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 124901653 | 12490165 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 124901653 | 12490165 | 9 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 124901653 | 12490165 | 10 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | DOSE PER APPLICATION: 10 MG / 325 MG | 0 | TABLET | |||||||||
| 124901653 | 12490165 | 11 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 124901653 | 12490165 | 12 | C | POTASSIUM | POTASSIUM | 1 | Oral | 20 MEQ | 0 | 20 | MEQ | TABLET | |||||||
| 124901653 | 12490165 | 13 | C | ZONISAMIDE. | ZONISAMIDE | 1 | Oral | 2 ANZ | 0 | TABLET | QD | ||||||||
| 124901653 | 12490165 | 14 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 2 ANZ | 0 | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124901653 | 12490165 | 1 | Chronic obstructive pulmonary disease |
| 124901653 | 12490165 | 3 | Product used for unknown indication |
| 124901653 | 12490165 | 4 | Anxiety |
| 124901653 | 12490165 | 5 | Depression |
| 124901653 | 12490165 | 6 | Anxiety |
| 124901653 | 12490165 | 7 | Blood cholesterol increased |
| 124901653 | 12490165 | 8 | Hypertension |
| 124901653 | 12490165 | 9 | Dust allergy |
| 124901653 | 12490165 | 10 | Back pain |
| 124901653 | 12490165 | 11 | Product used for unknown indication |
| 124901653 | 12490165 | 12 | Muscle spasms |
| 124901653 | 12490165 | 13 | Back pain |
| 124901653 | 12490165 | 14 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124901653 | 12490165 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124901653 | 12490165 | Fluid retention | |
| 124901653 | 12490165 | Gastrooesophageal reflux disease | |
| 124901653 | 12490165 | Incorrect dose administered | |
| 124901653 | 12490165 | Musculoskeletal chest pain | |
| 124901653 | 12490165 | Pneumonia | |
| 124901653 | 12490165 | Product quality issue | |
| 124901653 | 12490165 | Throat irritation | |
| 124901653 | 12490165 | Vomiting | |
| 124901653 | 12490165 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124901653 | 12490165 | 1 | 201510 | 201511 | 0 | |
| 124901653 | 12490165 | 2 | 20160605 | 0 | ||
| 124901653 | 12490165 | 3 | 201604 | 20160408 | 0 | |
| 124901653 | 12490165 | 13 | 20160603 | 0 | ||
| 124901653 | 12490165 | 14 | 201604 | 0 |