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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125645291 | 12564529 | 1 | I | 20160122 | 20160718 | 20160718 | EXP | US-CIPLA LTD.-2016US07117 | CIPLA | 0.00 | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125645291 | 12564529 | 1 | PS | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | Oral | 12 MG, UNK | I1504819 | 90935 | 12 | MG | TABLET | ||||||
| 125645291 | 12564529 | 2 | C | Amitriptyline | AMITRIPTYLINE | 1 | Unknown | 25 MG, QD, 3 TABLETS AT BED TIME | U | U | 0 | 25 | MG | TABLET | |||||
| 125645291 | 12564529 | 3 | C | Insulin Novolog | 2 | Unknown | 30 UNITS MORNING AND 36 UNITS EVENING | U | U | 0 | |||||||||
| 125645291 | 12564529 | 4 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 2 PUFFS EVERY DAY | U | U | 0 | INHALER | |||||||
| 125645291 | 12564529 | 5 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Nasal | ONCE DAILY IN EACH NOSTRIL, QD | U | U | 0 | SPRAY (EXCEPT INHALATION) | |||||||
| 125645291 | 12564529 | 6 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | 45 UNITS AT BED TIME, QD | U | U | 0 | ||||||||
| 125645291 | 12564529 | 7 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | 2 PUFFS EVERY 6 HOURS | U | U | 0 | INHALER | |||||||
| 125645291 | 12564529 | 8 | C | SODIUM FLUORIDE. | SODIUM FLUORIDE | 1 | Topical | 1.1 %, BID | U | U | 0 | 1.1 | PCT | CREAM | |||||
| 125645291 | 12564529 | 9 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | 100 MG, FOR EVERY 12 HOURS | U | U | 0 | 100 | MG | INJECTION | |||||
| 125645291 | 12564529 | 10 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 5 MG,HALF TABLET, QD | U | U | 0 | 5 | MG | TABLET | |||||
| 125645291 | 12564529 | 11 | C | ASCORBIC ACID. | ASCORBIC ACID | 1 | Unknown | 500 MG, QD | U | U | 0 | 500 | MG | ||||||
| 125645291 | 12564529 | 12 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 81 MG, QD | U | U | 0 | 81 | MG | TABLET | |||||
| 125645291 | 12564529 | 13 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Unknown | 325 MG, QD | U | U | 0 | 325 | MG | TABLET | |||||
| 125645291 | 12564529 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 100 MG, FOR EVERY 8 HOURS | U | U | 0 | 100 | MG | CAPSULE | |||||
| 125645291 | 12564529 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, 2 CAPS, QD | U | U | 0 | 20 | MG | CAPSULE | |||||
| 125645291 | 12564529 | 16 | C | LIDOCAINE. | LIDOCAINE | 1 | 5 %, UNK | U | U | 0 | 5 | PCT | OINTMENT, CREAM | ||||||
| 125645291 | 12564529 | 17 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 1000 MG, BID | U | U | 0 | 1000 | MG | TABLET | |||||
| 125645291 | 12564529 | 18 | C | Metoprolol tartarate | METOPROLOL TARTRATE | 1 | Unknown | 50 MG, HALF A TABLET, BID | U | U | 0 | 50 | MG | TABLET | |||||
| 125645291 | 12564529 | 19 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | UNKNOWN | U | U | 0 | INHALER | |||||||
| 125645291 | 12564529 | 20 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 50 MG, QID | U | U | 0 | 50 | MG | TABLET | |||||
| 125645291 | 12564529 | 21 | C | VIAGRA | SILDENAFIL CITRATE | 1 | Unknown | 100 MG, PM | U | U | 0 | 100 | MG | TABLET | |||||
| 125645291 | 12564529 | 22 | C | Prazosin | PRAZOSIN | 1 | Unknown | 2 MG,2 CAPSULES AT BED TIME, QD | U | U | 0 | 2 | MG | TABLET | |||||
| 125645291 | 12564529 | 23 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 150 MG, PM AT BED TIME | U | U | 0 | 150 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125645291 | 12564529 | 1 | Thrombosis |
| 125645291 | 12564529 | 2 | Pain |
| 125645291 | 12564529 | 3 | Diabetes mellitus |
| 125645291 | 12564529 | 4 | Chronic obstructive pulmonary disease |
| 125645291 | 12564529 | 5 | Hypersensitivity |
| 125645291 | 12564529 | 7 | Wheezing |
| 125645291 | 12564529 | 8 | Tooth disorder |
| 125645291 | 12564529 | 9 | Thrombosis |
| 125645291 | 12564529 | 10 | Hypertension |
| 125645291 | 12564529 | 12 | Cardiac disorder |
| 125645291 | 12564529 | 13 | Anaemia |
| 125645291 | 12564529 | 14 | Neuropathy peripheral |
| 125645291 | 12564529 | 15 | Gastrooesophageal reflux disease |
| 125645291 | 12564529 | 16 | Back pain |
| 125645291 | 12564529 | 17 | Diabetes mellitus |
| 125645291 | 12564529 | 18 | Hypertension |
| 125645291 | 12564529 | 19 | Chronic obstructive pulmonary disease |
| 125645291 | 12564529 | 20 | Pain |
| 125645291 | 12564529 | 22 | Benign prostatic hyperplasia |
| 125645291 | 12564529 | 23 | Gastrooesophageal reflux disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125645291 | 12564529 | Drug ineffective | |
| 125645291 | 12564529 | International normalised ratio decreased |
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 |
|---|---|---|---|---|---|---|
| 125645291 | 12564529 | 1 | 201511 | 0 |