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 (8477)


DYSPNOEA (8071)


NAUSEA (7863)


DRUG INEFFECTIVE (7437)


DIARRHOEA (7362)


DIZZINESS (7103)


FALL (6086)


ASTHENIA (5601)


DRUG INTERACTION (5418)


PAIN (5393)


HEADACHE (5384)


MYALGIA (5243)


MALAISE (5020)


VOMITING (4968)


PAIN IN EXTREMITY (4630)


ACUTE KIDNEY INJURY (4609)


ARTHRALGIA (4464)


PNEUMONIA (3946)


DEATH (3723)


RENAL FAILURE (3722)


WEIGHT DECREASED (3714)


CHRONIC KIDNEY DISEASE (3624)


OFF LABEL USE (3623)


PRURITUS (3487)


RASH (3402)


RHABDOMYOLYSIS (3362)


HYPOTENSION (3359)


CONFUSIONAL STATE (3305)


COUGH (3275)


ANAEMIA (3214)


INSOMNIA (3173)


GAIT DISTURBANCE (3103)


CHEST PAIN (3045)


DECREASED APPETITE (2967)


PYREXIA (2926)


BACK PAIN (2889)


MUSCLE SPASMS (2822)


HYPERTENSION (2802)


DEPRESSION (2734)


CONSTIPATION (2694)


MUSCULAR WEAKNESS (2611)


MYOCARDIAL INFARCTION (2565)


ANXIETY (2564)


ABDOMINAL PAIN (2502)


FEELING ABNORMAL (2497)


BLOOD GLUCOSE INCREASED (2483)


CEREBROVASCULAR ACCIDENT (2456)


GASTROINTESTINAL HAEMORRHAGE (2414)


URINARY TRACT INFECTION (2397)


OEDEMA PERIPHERAL (2371)


DEHYDRATION (2368)


FLUSHING (2319)


RENAL FAILURE ACUTE (2309)


CONDITION AGGRAVATED (2265)


SYNCOPE (2247)


ATRIAL FIBRILLATION (2235)


SOMNOLENCE (2217)


ABDOMINAL PAIN UPPER (2205)


PARAESTHESIA (2201)


GENERAL PHYSICAL HEALTH DETERIORATION (2164)


BLOOD PRESSURE INCREASED (2001)


TREMOR (1975)


WEIGHT INCREASED (1959)


ALOPECIA (1935)


HYPOAESTHESIA (1810)


LOSS OF CONSCIOUSNESS (1798)


HYPERHIDROSIS (1788)


DRUG DOSE OMISSION (1765)


BALANCE DISORDER (1731)


ERYTHEMA (1718)


MEMORY IMPAIRMENT (1707)


HAEMOGLOBIN DECREASED (1688)


PERIPHERAL SWELLING (1687)


HYPONATRAEMIA (1639)


ABDOMINAL DISCOMFORT (1625)


SEPSIS (1603)


BLOOD CREATINE PHOSPHOKINASE INCREASED (1523)


RENAL IMPAIRMENT (1490)


CONTUSION (1473)


VISION BLURRED (1468)


INJECTION SITE PAIN (1442)


CARDIAC FAILURE CONGESTIVE (1439)


PALPITATIONS (1395)


BLOOD CREATININE INCREASED (1388)


NASOPHARYNGITIS (1385)


PRODUCT QUALITY ISSUE (1338)


DRUG HYPERSENSITIVITY (1332)


DYSPEPSIA (1330)


EPISTAXIS (1298)


HYPOGLYCAEMIA (1291)


HYPERSENSITIVITY (1284)


GASTROOESOPHAGEAL REFLUX DISEASE (1253)


BRADYCARDIA (1242)


DIABETES MELLITUS (1231)


DYSPHAGIA (1224)


CARDIAC FAILURE (1220)


VISUAL IMPAIRMENT (1197)


INCORRECT DOSE ADMINISTERED (1195)


JOINT SWELLING (1189)


ABDOMINAL DISTENSION (1179)