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 (8203)


DYSPNOEA (7849)


NAUSEA (7633)


DRUG INEFFECTIVE (7249)


DIARRHOEA (7127)


DIZZINESS (6908)


FALL (5902)


ASTHENIA (5457)


DRUG INTERACTION (5290)


PAIN (5261)


HEADACHE (5238)


MYALGIA (5161)


MALAISE (4918)


VOMITING (4826)


PAIN IN EXTREMITY (4518)


ARTHRALGIA (4360)


ACUTE KIDNEY INJURY (4304)


PNEUMONIA (3844)


WEIGHT DECREASED (3618)


RENAL FAILURE (3508)


DEATH (3484)


PRURITUS (3395)


OFF LABEL USE (3386)


RASH (3315)


RHABDOMYOLYSIS (3313)


HYPOTENSION (3285)


CONFUSIONAL STATE (3244)


CHRONIC KIDNEY DISEASE (3242)


COUGH (3171)


INSOMNIA (3120)


ANAEMIA (3100)


GAIT DISTURBANCE (3029)


CHEST PAIN (2998)


DECREASED APPETITE (2899)


PYREXIA (2848)


BACK PAIN (2822)


MUSCLE SPASMS (2753)


HYPERTENSION (2730)


DEPRESSION (2684)


CONSTIPATION (2573)


MUSCULAR WEAKNESS (2556)


MYOCARDIAL INFARCTION (2540)


ANXIETY (2497)


BLOOD GLUCOSE INCREASED (2445)


FEELING ABNORMAL (2432)


CEREBROVASCULAR ACCIDENT (2412)


ABDOMINAL PAIN (2400)


GASTROINTESTINAL HAEMORRHAGE (2385)


OEDEMA PERIPHERAL (2334)


DEHYDRATION (2333)


URINARY TRACT INFECTION (2317)


RENAL FAILURE ACUTE (2311)


FLUSHING (2298)


SYNCOPE (2210)


ATRIAL FIBRILLATION (2186)


CONDITION AGGRAVATED (2185)


SOMNOLENCE (2163)


PARAESTHESIA (2155)


ABDOMINAL PAIN UPPER (2136)


GENERAL PHYSICAL HEALTH DETERIORATION (2062)


BLOOD PRESSURE INCREASED (1951)


TREMOR (1922)


WEIGHT INCREASED (1922)


ALOPECIA (1885)


DRUG DOSE OMISSION (1769)


HYPOAESTHESIA (1768)


LOSS OF CONSCIOUSNESS (1765)


HYPERHIDROSIS (1759)


BALANCE DISORDER (1688)


ERYTHEMA (1688)


HAEMOGLOBIN DECREASED (1660)


MEMORY IMPAIRMENT (1653)


PERIPHERAL SWELLING (1614)


HYPONATRAEMIA (1578)


ABDOMINAL DISCOMFORT (1563)


SEPSIS (1537)


BLOOD CREATINE PHOSPHOKINASE INCREASED (1504)


RENAL IMPAIRMENT (1444)


VISION BLURRED (1438)


CONTUSION (1431)


CARDIAC FAILURE CONGESTIVE (1416)


INJECTION SITE PAIN (1412)


BLOOD CREATININE INCREASED (1367)


PALPITATIONS (1366)


NASOPHARYNGITIS (1361)


PRODUCT QUALITY ISSUE (1324)


DYSPEPSIA (1306)


DRUG HYPERSENSITIVITY (1297)


EPISTAXIS (1284)


HYPOGLYCAEMIA (1256)


HYPERSENSITIVITY (1241)


BRADYCARDIA (1208)


DIABETES MELLITUS (1208)


DYSPHAGIA (1197)


CARDIAC FAILURE (1195)


VISUAL IMPAIRMENT (1167)


INCORRECT DOSE ADMINISTERED (1164)


JOINT SWELLING (1159)


AMNESIA (1152)


MUSCULOSKELETAL PAIN (1152)