openFDA Drug Adverse Events

“The openFDA drug adverse event API returns data that has been collected from the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to FDA.”

“Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product.”

The following are the top 100 reported drug adverse events.

FATIGUE (8987)


DYSPNOEA (8454)


NAUSEA (8263)


DIARRHOEA (7781)


DRUG INEFFECTIVE (7729)


DIZZINESS (7416)


FALL (6405)


ASTHENIA (5920)


PAIN (5645)


HEADACHE (5632)


DRUG INTERACTION (5625)


MYALGIA (5397)


VOMITING (5250)


MALAISE (5210)


ACUTE KIDNEY INJURY (4973)


PAIN IN EXTREMITY (4811)


ARTHRALGIA (4678)


PNEUMONIA (4080)


DEATH (4021)


OFF LABEL USE (3986)


CHRONIC KIDNEY DISEASE (3947)


RENAL FAILURE (3932)


WEIGHT DECREASED (3869)


PRURITUS (3646)


RASH (3547)


HYPOTENSION (3468)


RHABDOMYOLYSIS (3442)


COUGH (3439)


ANAEMIA (3419)


CONFUSIONAL STATE (3386)


INSOMNIA (3289)


GAIT DISTURBANCE (3209)


CHEST PAIN (3143)


DECREASED APPETITE (3119)


PYREXIA (3115)


BACK PAIN (3007)


HYPERTENSION (2944)


MUSCLE SPASMS (2913)


CONSTIPATION (2895)


DEPRESSION (2787)


ABDOMINAL PAIN (2735)


MUSCULAR WEAKNESS (2692)


ANXIETY (2648)


MYOCARDIAL INFARCTION (2618)


FEELING ABNORMAL (2555)


BLOOD GLUCOSE INCREASED (2551)


URINARY TRACT INFECTION (2534)


CEREBROVASCULAR ACCIDENT (2531)


DEHYDRATION (2462)


OEDEMA PERIPHERAL (2456)


GASTROINTESTINAL HAEMORRHAGE (2450)


CONDITION AGGRAVATED (2427)


GENERAL PHYSICAL HEALTH DETERIORATION (2424)


ABDOMINAL PAIN UPPER (2363)


FLUSHING (2352)


SOMNOLENCE (2347)


ATRIAL FIBRILLATION (2333)


SYNCOPE (2324)


RENAL FAILURE ACUTE (2308)


PARAESTHESIA (2275)


BLOOD PRESSURE INCREASED (2104)


TREMOR (2067)


WEIGHT INCREASED (2026)


ALOPECIA (2015)


HYPOAESTHESIA (1880)


HYPERHIDROSIS (1841)


LOSS OF CONSCIOUSNESS (1841)


PERIPHERAL SWELLING (1821)


BALANCE DISORDER (1816)


ERYTHEMA (1786)


MEMORY IMPAIRMENT (1766)


DRUG DOSE OMISSION (1765)


HYPONATRAEMIA (1760)


SEPSIS (1760)


HAEMOGLOBIN DECREASED (1749)


ABDOMINAL DISCOMFORT (1696)


RENAL IMPAIRMENT (1608)


BLOOD CREATINE PHOSPHOKINASE INCREASED (1560)


VISION BLURRED (1531)


CONTUSION (1516)


INJECTION SITE PAIN (1473)


CARDIAC FAILURE CONGESTIVE (1457)


PALPITATIONS (1447)


NASOPHARYNGITIS (1439)


BLOOD CREATININE INCREASED (1430)


DRUG HYPERSENSITIVITY (1403)


GASTROOESOPHAGEAL REFLUX DISEASE (1388)


DYSPEPSIA (1378)


EPISTAXIS (1350)


PRODUCT QUALITY ISSUE (1348)


HYPERSENSITIVITY (1334)


HYPOGLYCAEMIA (1329)


BRADYCARDIA (1282)


VISUAL IMPAIRMENT (1279)


DIABETES MELLITUS (1267)


ABDOMINAL DISTENSION (1266)


CARDIAC FAILURE (1265)


DYSPHAGIA (1259)


CHILLS (1256)


JOINT SWELLING (1250)