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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8248633 | 8485917 | I | 8248633-9 | 20120319 | 20120331 | EXP | US-MYLANLABS-2012S1006624 | MYLAN PHARMACEUTICALS INC. | YR | F | Y | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8248633 | 1019282266 | C | AMOXICILLIN | 1 | |||||||
| 8248633 | 1019282272 | C | CELEBREX | 1 | |||||||
| 8248633 | 1019282280 | C | DURICEF | 1 | X5 DAYS | ||||||
| 8248633 | 1019282292 | C | MINITRAN | 1 | |||||||
| 8248633 | 1019282293 | C | MORPHINE | 1 | |||||||
| 8248633 | 1019282302 | C | RESTORIL | 1 | |||||||
| 8248633 | 1019282303 | C | SERZONE | 1 | |||||||
| 8248633 | 1019282265 | C | AMITRIPTYLINE HCL | 1 | |||||||
| 8248633 | 1019282269 | C | BACLOFEN | 1 | |||||||
| 8248633 | 1019282273 | C | CLAFORAN | 1 | |||||||
| 8248633 | 1019282279 | C | DOXYCYCLINE | 1 | |||||||
| 8248633 | 1019282281 | C | ELAVIL | 1 | |||||||
| 8248633 | 1019282289 | C | LEXAPRO | 1 | |||||||
| 8248633 | 1019282307 | C | ZANAFLEX | 1 | |||||||
| 8248633 | 1019282262 | C | ALBUTEROL | 1 | RESPIRATORY (INHALATION) | ||||||
| 8248633 | 1019282275 | C | COREG | 1 | |||||||
| 8248633 | 1019282277 | C | COUMADIN | 1 | |||||||
| 8248633 | 1019282285 | C | INFLUENZA HA VACCINE | 2 | |||||||
| 8248633 | 1019282288 | C | LASIX | 1 | |||||||
| 8248633 | 1019282290 | C | LISINOPRIL | 1 | |||||||
| 8248633 | 1019282296 | C | PHENERGAN EXPECTORANT W/ CODEINE | 1 | 6.25MG/10MG/5ML EVERY 6 HOURS | ||||||
| 8248633 | 1019282261 | PS | DIGOXIN | 1 | ORAL | 040282 | |||||
| 8248633 | 1019282284 | C | HYDROCODONE BITARTRATE | 1 | 7.5/750MG | ||||||
| 8248633 | 1019282299 | C | PRILOSEC | 1 | |||||||
| 8248633 | 1019282264 | C | AMBIEN | 1 | FOR ONE MONTH | ||||||
| 8248633 | 1019282268 | C | ASPIRIN | 1 | |||||||
| 8248633 | 1019282283 | C | HYCOTUSS | 2 | |||||||
| 8248633 | 1019282286 | C | IRON | 2 | |||||||
| 8248633 | 1019282291 | C | METFORMIN HCL | 1 | |||||||
| 8248633 | 1019282304 | C | TRAZODONE HCL | 1 | |||||||
| 8248633 | 1019282267 | C | ANUSOL /00117301/ | 2 | |||||||
| 8248633 | 1019282271 | C | BIAXIN | 1 | |||||||
| 8248633 | 1019282276 | C | CORTISONE | 2 | TOPICAL | ||||||
| 8248633 | 1019282282 | C | GLYBURIDE | 1 | 5 MG TABLETS | ||||||
| 8248633 | 1019282287 | C | POTASSIUM CHLORIDE | 1 | |||||||
| 8248633 | 1019282298 | C | PRAVASTATIN | 1 | |||||||
| 8248633 | 1019282301 | C | REDUX /01356802/ | 2 | |||||||
| 8248633 | 1019282308 | C | ZESTRIL | 1 | |||||||
| 8248633 | 1019282270 | C | BENTYL | 1 | |||||||
| 8248633 | 1019282294 | C | NORFLEX | 1 | |||||||
| 8248633 | 1019282297 | C | POTASSIUM | 2 | |||||||
| 8248633 | 1019282300 | C | PROVENTIL | 1 | |||||||
| 8248633 | 1019282305 | C | ULTRAM | 1 | |||||||
| 8248633 | 1019282263 | C | ALDACTONE | 1 | |||||||
| 8248633 | 1019282274 | C | CLARITIN /00917501/ | 2 | |||||||
| 8248633 | 1019282278 | C | DARVOCET | 1 | |||||||
| 8248633 | 1019282295 | C | NITRO-DUR | 1 | |||||||
| 8248633 | 1019282306 | C | VICODIN | 1 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8248633 | OT |
| 8248633 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 8248633 | DYSPNOEA EXERTIONAL |
| 8248633 | MITRAL VALVE INCOMPETENCE |
| 8248633 | ARTERIOSCLEROSIS |
| 8248633 | CARPAL TUNNEL SYNDROME |
| 8248633 | DYSPEPSIA |
| 8248633 | RADICULOPATHY |
| 8248633 | NECK PAIN |
| 8248633 | PAIN IN EXTREMITY |
| 8248633 | MUSCULOSKELETAL STIFFNESS |
| 8248633 | OROPHARYNGEAL PAIN |
| 8248633 | RHINORRHOEA |
| 8248633 | SPINAL CORD DISORDER |
| 8248633 | MAMMOGRAM ABNORMAL |
| 8248633 | SPIROMETRY ABNORMAL |
| 8248633 | PRODUCTIVE COUGH |
| 8248633 | HYPERTHYROIDISM |
| 8248633 | DILATATION ATRIAL |
| 8248633 | PLEURAL EFFUSION |
| 8248633 | CARDIOVASCULAR DECONDITIONING |
| 8248633 | RESTRICTIVE PULMONARY DISEASE |
| 8248633 | CONTUSION |
| 8248633 | SPINAL COLUMN STENOSIS |
| 8248633 | OVARIAN CYST |
| 8248633 | UTERINE LEIOMYOMA |
| 8248633 | VENTRICULAR EXTRASYSTOLES |
| 8248633 | SINUS TACHYCARDIA |
| 8248633 | WHEEZING |
| 8248633 | VENTRICULAR DYSFUNCTION |
| 8248633 | BACK PAIN |
| 8248633 | DIARRHOEA |
| 8248633 | OBESITY |
| 8248633 | LETHARGY |
| 8248633 | RESPIRATORY TRACT CONGESTION |
| 8248633 | GASTROOESOPHAGEAL REFLUX DISEASE |
| 8248633 | LABORATORY TEST ABNORMAL |
| 8248633 | SCAN MYOCARDIAL PERFUSION ABNORMAL |
| 8248633 | TENDERNESS |
| 8248633 | DIABETES MELLITUS |
| 8248633 | CARDIOMYOPATHY |
| 8248633 | PULMONARY HYPERTENSION |
| 8248633 | ATELECTASIS |
| 8248633 | AORTIC DISORDER |
| 8248633 | CRYING |
| 8248633 | STRESS URINARY INCONTINENCE |
| 8248633 | FEELING COLD |
| 8248633 | HYPERTROPHIC SCAR |
| 8248633 | PYREXIA |
| 8248633 | RHONCHI |
| 8248633 | CONDITION AGGRAVATED |
| 8248633 | DIASTOLIC DYSFUNCTION |
| 8248633 | ATRIAL SEPTAL DEFECT |
| 8248633 | ABDOMINAL PAIN |
| 8248633 | OEDEMA |
| 8248633 | COSTOCHONDRITIS |
| 8248633 | UPPER RESPIRATORY TRACT INFECTION |
| 8248633 | MUSCULOSKELETAL PAIN |
| 8248633 | OVARIAN ENLARGEMENT |
| 8248633 | LUNG INFILTRATION |
| 8248633 | BREATH SOUNDS ABNORMAL |
| 8248633 | CARDIOMEGALY |
| 8248633 | RESPIRATION ABNORMAL |
| 8248633 | OXYGEN SATURATION ABNORMAL |
| 8248633 | SYNCOPE |
| 8248633 | TACHYCARDIA |
| 8248633 | HYPERTENSION |
| 8248633 | DYSPHAGIA |
| 8248633 | LYMPHOCYTOSIS |
| 8248633 | ORTHOPNOEA |
| 8248633 | OEDEMA PERIPHERAL |
| 8248633 | DYSPNOEA PAROXYSMAL NOCTURNAL |
| 8248633 | FLUID RETENTION |
| 8248633 | LIGAMENT SPRAIN |
| 8248633 | INSOMNIA |
| 8248633 | ROTATOR CUFF SYNDROME |
| 8248633 | JOINT EFFUSION |
| 8248633 | DEPRESSION |
| 8248633 | RALES |
| 8248633 | CARDIAC VALVE DISEASE |
| 8248633 | HAEMOPTYSIS |
| 8248633 | PALPITATIONS |
| 8248633 | FATIGUE |
| 8248633 | MALAISE |
| 8248633 | CHILLS |
| 8248633 | OESOPHAGEAL STENOSIS |
| 8248633 | BACK INJURY |
| 8248633 | ANXIETY |
| 8248633 | MUSCLE STRAIN |
| 8248633 | HAEMORRHOIDS |
| 8248633 | UTERINE ENLARGEMENT |
| 8248633 | ENDOMETRIAL DISORDER |
| 8248633 | LUNG DISORDER |
| 8248633 | ARTHRALGIA |
| 8248633 | JOINT INJURY |
| 8248633 | PNEUMONIA |
| 8248633 | MICROVASCULAR ANGINA |
| 8248633 | DILATATION VENTRICULAR |
| 8248633 | HYPOKINESIA |
| 8248633 | CHEST DISCOMFORT |
| 8248633 | HEADACHE |
| 8248633 | NEUTROPENIA |
| 8248633 | DIZZINESS |
| 8248633 | CHEST PAIN |
| 8248633 | MITRAL VALVE REPAIR |
| 8248633 | WOUND COMPLICATION |
| 8248633 | IMPLANTABLE DEFIBRILLATOR INSERTION |
| 8248633 | CARDIAC MURMUR |
| 8248633 | HYPOTENSION |
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 |
|---|---|---|---|---|---|
| 8248633 | 1019282261 | 20000627 | 20100212 | ||
| 8248633 | 1019282301 | 19960101 | 19960101 | 6 | MON |