Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8248631 | 8485915 | I | 8248631-5 | 20120319 | 20120331 | EXP | US-MYLANLABS-2012S1006450 | MYLAN PHARMACEUTICALS INC. | YR | F | Y | 50.8 | KG | 20120330 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8248631 | 1019282186 | SS | DIGOXIN | 1 | 040282 | ||||||
| 8248631 | 1019282204 | C | ISOSORBIDE DINITRATE | 1 | |||||||
| 8248631 | 1019282207 | C | LIPITOR | 1 | |||||||
| 8248631 | 1019282209 | C | MILK OF MAGNESIA TAB | 1 | |||||||
| 8248631 | 1019282212 | C | NEXIUM | 1 | |||||||
| 8248631 | 1019282220 | C | ROCEPHIN | 1 | |||||||
| 8248631 | 1019282227 | C | ZANTAC | 1 | |||||||
| 8248631 | 1019282187 | C | ACIPHEX | 1 | |||||||
| 8248631 | 1019282189 | C | ASPIRIN | 1 | |||||||
| 8248631 | 1019282191 | C | BEXTRA /01400702/ | 2 | |||||||
| 8248631 | 1019282213 | C | NITROGLYCERIN | 1 | |||||||
| 8248631 | 1019282218 | C | PRILOSEC | 1 | |||||||
| 8248631 | 1019282228 | C | ZINC OXIDE | 2 | TOPICAL | ||||||
| 8248631 | 1019282192 | C | CALCIUM CARBONATE | 1 | |||||||
| 8248631 | 1019282200 | C | DIPHENOXYLATE | 2 | |||||||
| 8248631 | 1019282225 | C | TRAMADOL HCL | 1 | |||||||
| 8248631 | 1019282194 | C | CARTIA XT | 1 | |||||||
| 8248631 | 1019282197 | C | COUMADIN | 1 | |||||||
| 8248631 | 1019282223 | C | TESSALON | 1 | |||||||
| 8248631 | 1019282211 | C | GEN-BUDESONIDE AQ NASAL SPRAY 100 MCG/MET. DOSE | 2 | |||||||
| 8248631 | 1019282214 | C | OS-CAL 500 + D | 2 | |||||||
| 8248631 | 1019282216 | C | POTASSIUM CHLORIDE | 1 | |||||||
| 8248631 | 1019282188 | C | ALBUTEROL | 1 | |||||||
| 8248631 | 1019282190 | C | ATROVENT | 1 | |||||||
| 8248631 | 1019282193 | C | CARDIZEM | 1 | |||||||
| 8248631 | 1019282199 | C | DIOVAN | 1 | |||||||
| 8248631 | 1019282201 | C | GLUCOSAMINE | 2 | |||||||
| 8248631 | 1019282202 | C | GUAIFENESIN | 1 | |||||||
| 8248631 | 1019282215 | C | PLAVIX | 1 | |||||||
| 8248631 | 1019282221 | C | STOOL SOFTENER | 2 | |||||||
| 8248631 | 1019282226 | C | ULTRAM | 1 | |||||||
| 8248631 | 1019282203 | C | HEPARIN | 1 | |||||||
| 8248631 | 1019282205 | C | KLOR-CON | 1 | |||||||
| 8248631 | 1019282208 | C | LOMOTIL | 1 | |||||||
| 8248631 | 1019282219 | C | PROTONIX | 1 | |||||||
| 8248631 | 1019282222 | C | SYNTHROID | 1 | |||||||
| 8248631 | 1019282224 | C | TOPROL-XL | 1 | |||||||
| 8248631 | 1019282185 | PS | DIGOXIN | 1 | 040282 | ||||||
| 8248631 | 1019282195 | C | MULTI-VITAMINS | 1 | |||||||
| 8248631 | 1019282196 | C | CODEINE SULFATE | 1 | |||||||
| 8248631 | 1019282198 | C | DARVOCET-N 100 | 1 | 100/650MG | ||||||
| 8248631 | 1019282206 | C | LASIX | 1 | |||||||
| 8248631 | 1019282210 | C | MULTI-VITAMINS | 1 | |||||||
| 8248631 | 1019282217 | C | PRAVACHOL | 1 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 8248631 | 1019282186 | CARDIAC FAILURE CONGESTIVE |
| 8248631 | 1019282185 | ATRIAL FIBRILLATION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8248631 | DS |
| 8248631 | HO |
| 8248631 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 8248631 | LUNG NEOPLASM MALIGNANT |
| 8248631 | DEMENTIA |
| 8248631 | CARDIOMYOPATHY |
| 8248631 | NOCTURIA |
| 8248631 | HYPERLIPIDAEMIA |
| 8248631 | OSTEOPOROSIS |
| 8248631 | SKELETAL INJURY |
| 8248631 | WALKING DISABILITY |
| 8248631 | PULMONARY HYPERTENSION |
| 8248631 | CARDIAC FAILURE CONGESTIVE |
| 8248631 | HYPERTENSION |
| 8248631 | THYROID DISORDER |
| 8248631 | EAR PAIN |
| 8248631 | WEIGHT INCREASED |
| 8248631 | ASTHENIA |
| 8248631 | MUSCULOSKELETAL PAIN |
| 8248631 | RHINORRHOEA |
| 8248631 | MALAISE |
| 8248631 | BALANCE DISORDER |
| 8248631 | CONTUSION |
| 8248631 | CONSTIPATION |
| 8248631 | OXYGEN SATURATION DECREASED |
| 8248631 | NAUSEA |
| 8248631 | SICK SINUS SYNDROME |
| 8248631 | DYSURIA |
| 8248631 | DYSPNOEA |
| 8248631 | PERIPHERAL VASCULAR DISORDER |
| 8248631 | DECREASED APPETITE |
| 8248631 | CHEST DISCOMFORT |
| 8248631 | CHEST PAIN |
| 8248631 | SOMNOLENCE |
| 8248631 | RIB FRACTURE |
| 8248631 | VOMITING |
| 8248631 | HYPOTENSION |
| 8248631 | INTERMITTENT CLAUDICATION |
| 8248631 | ARTERIOSCLEROSIS CORONARY ARTERY |
| 8248631 | CEREBROVASCULAR ACCIDENT |
| 8248631 | HYPERCHOLESTEROLAEMIA |
| 8248631 | MUSCULOSKELETAL CHEST PAIN |
| 8248631 | WEIGHT DECREASED |
| 8248631 | SKIN ULCER |
| 8248631 | PAIN IN EXTREMITY |
| 8248631 | ATRIAL FIBRILLATION |
| 8248631 | AORTIC OCCLUSION |
| 8248631 | CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
| 8248631 | FRACTURED SACRUM |
| 8248631 | BACK PAIN |
| 8248631 | DEHYDRATION |
| 8248631 | ANAEMIA |
| 8248631 | PULMONARY EMBOLISM |
| 8248631 | CORONARY ARTERY DISEASE |
| 8248631 | HYPOXIA |
| 8248631 | DEEP VEIN THROMBOSIS |
| 8248631 | DEMENTIA ALZHEIMER'S TYPE |
| 8248631 | COUGH |
| 8248631 | CAROTID BRUIT |
| 8248631 | FATIGUE |
| 8248631 | SPINAL COLUMN INJURY |
| 8248631 | PAIN |
| 8248631 | HEART RATE INCREASED |
| 8248631 | HYPERHIDROSIS |
| 8248631 | DIARRHOEA |
| 8248631 | EMBOLISM VENOUS |
| 8248631 | PNEUMONIA |
| 8248631 | PARAESTHESIA |
| 8248631 | FALL |
| 8248631 | LIMB INJURY |
| 8248631 | FRACTURED COCCYX |
| 8248631 | OSTEOARTHRITIS |
| 8248631 | URINARY TRACT INFECTION |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 8248631 | 1019282186 | 20021007 | 20090626 | ||
| 8248631 | 1019282185 | 20021007 | 20090626 |