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 (9260)


DYSPNOEA (8643)


NAUSEA (8572)


DIARRHOEA (8044)


DRUG INEFFECTIVE (7937)


DIZZINESS (7620)


FALL (6566)


ASTHENIA (6090)


PAIN (5849)


HEADACHE (5833)


DRUG INTERACTION (5814)


MYALGIA (5510)


VOMITING (5436)


MALAISE (5353)


ACUTE KIDNEY INJURY (5192)


PAIN IN EXTREMITY (4917)


ARTHRALGIA (4846)


OFF LABEL USE (4278)


DEATH (4199)


PNEUMONIA (4195)


CHRONIC KIDNEY DISEASE (4137)


RENAL FAILURE (4056)


WEIGHT DECREASED (3981)


PRURITUS (3799)


RASH (3636)


COUGH (3550)


HYPOTENSION (3546)


ANAEMIA (3532)


RHABDOMYOLYSIS (3491)


CONFUSIONAL STATE (3436)


INSOMNIA (3404)


GAIT DISTURBANCE (3280)


DECREASED APPETITE (3245)


PYREXIA (3243)


CHEST PAIN (3202)


BACK PAIN (3071)


HYPERTENSION (3032)


CONSTIPATION (3022)


MUSCLE SPASMS (2965)


ABDOMINAL PAIN (2891)


DEPRESSION (2822)


MUSCULAR WEAKNESS (2758)


ANXIETY (2700)


MYOCARDIAL INFARCTION (2647)


URINARY TRACT INFECTION (2614)


FEELING ABNORMAL (2606)


CONDITION AGGRAVATED (2587)


BLOOD GLUCOSE INCREASED (2584)


GENERAL PHYSICAL HEALTH DETERIORATION (2574)


CEREBROVASCULAR ACCIDENT (2566)


DEHYDRATION (2524)


OEDEMA PERIPHERAL (2510)


GASTROINTESTINAL HAEMORRHAGE (2475)


ABDOMINAL PAIN UPPER (2446)


SOMNOLENCE (2445)


SYNCOPE (2410)


ATRIAL FIBRILLATION (2390)


FLUSHING (2363)


PARAESTHESIA (2317)


RENAL FAILURE ACUTE (2309)


BLOOD PRESSURE INCREASED (2206)


TREMOR (2105)


WEIGHT INCREASED (2062)


ALOPECIA (2047)


HYPOAESTHESIA (1909)


PERIPHERAL SWELLING (1900)


SEPSIS (1873)


ERYTHEMA (1872)


LOSS OF CONSCIOUSNESS (1870)


HYPERHIDROSIS (1866)


BALANCE DISORDER (1849)


HYPONATRAEMIA (1845)


HAEMOGLOBIN DECREASED (1808)


MEMORY IMPAIRMENT (1806)


DRUG DOSE OMISSION (1764)


ABDOMINAL DISCOMFORT (1745)


RENAL IMPAIRMENT (1675)


VISION BLURRED (1594)


BLOOD CREATINE PHOSPHOKINASE INCREASED (1588)


CONTUSION (1544)


INJECTION SITE PAIN (1490)


PALPITATIONS (1482)


CARDIAC FAILURE CONGESTIVE (1479)


GASTROOESOPHAGEAL REFLUX DISEASE (1465)


NASOPHARYNGITIS (1464)


DRUG HYPERSENSITIVITY (1460)


BLOOD CREATININE INCREASED (1449)


DYSPEPSIA (1420)


HYPERSENSITIVITY (1374)


EPISTAXIS (1368)


PRODUCT QUALITY ISSUE (1350)


HYPOGLYCAEMIA (1344)


ABDOMINAL DISTENSION (1337)


CHILLS (1332)


VISUAL IMPAIRMENT (1316)


CARDIAC FAILURE (1303)


JOINT SWELLING (1300)


BRADYCARDIA (1296)


DIABETES MELLITUS (1285)


DYSPHAGIA (1272)