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 (10165)


NAUSEA (9471)


DYSPNOEA (9446)


DIARRHOEA (8974)


DRUG INEFFECTIVE (8486)


DIZZINESS (8299)


FALL (6989)


HEADACHE (6604)


PAIN (6577)


ASTHENIA (6468)


VOMITING (6125)


DRUG INTERACTION (6073)


MALAISE (6016)


MYALGIA (5849)


ACUTE KIDNEY INJURY (5558)


ARTHRALGIA (5527)


PAIN IN EXTREMITY (5181)


OFF LABEL USE (5180)


DEATH (4724)


PRURITUS (4410)


PNEUMONIA (4408)


WEIGHT DECREASED (4294)


CHRONIC KIDNEY DISEASE (4235)


RENAL FAILURE (4173)


RASH (3944)


INSOMNIA (3921)


PYREXIA (3872)


COUGH (3868)


ANAEMIA (3867)


HYPOTENSION (3740)


CHEST PAIN (3633)


RHABDOMYOLYSIS (3589)


CONFUSIONAL STATE (3567)


BACK PAIN (3536)


DECREASED APPETITE (3518)


GAIT DISTURBANCE (3473)


CONSTIPATION (3385)


ABDOMINAL PAIN (3272)


HYPERTENSION (3227)


MUSCULAR WEAKNESS (3192)


ANXIETY (3144)


MUSCLE SPASMS (3135)


MYOCARDIAL INFARCTION (3037)


FEELING ABNORMAL (3025)


DEHYDRATION (2968)


BLOOD GLUCOSE INCREASED (2950)


DEPRESSION (2920)


ABDOMINAL PAIN UPPER (2904)


CONDITION AGGRAVATED (2872)


GENERAL PHYSICAL HEALTH DETERIORATION (2809)


URINARY TRACT INFECTION (2804)


SOMNOLENCE (2674)


CEREBROVASCULAR ACCIDENT (2653)


OEDEMA PERIPHERAL (2604)


SYNCOPE (2595)


ATRIAL FIBRILLATION (2568)


GASTROINTESTINAL HAEMORRHAGE (2511)


ALOPECIA (2406)


FLUSHING (2404)


PARAESTHESIA (2399)


BLOOD PRESSURE INCREASED (2394)


PERIPHERAL SWELLING (2367)


RENAL FAILURE ACUTE (2309)


HYPERHIDROSIS (2238)


TREMOR (2230)


ABDOMINAL DISCOMFORT (2188)


MEMORY IMPAIRMENT (2178)


WEIGHT INCREASED (2159)


SEPSIS (2096)


ERYTHEMA (2065)


HYPONATRAEMIA (2006)


HYPOAESTHESIA (1997)


LOSS OF CONSCIOUSNESS (1928)


BALANCE DISORDER (1923)


HAEMOGLOBIN DECREASED (1901)


PALPITATIONS (1896)


RENAL IMPAIRMENT (1794)


DRUG DOSE OMISSION (1763)


VISION BLURRED (1704)


VISUAL IMPAIRMENT (1691)


CONTUSION (1649)


BLOOD CREATINE PHOSPHOKINASE INCREASED (1630)


DRUG HYPERSENSITIVITY (1587)


TACHYCARDIA (1570)


NASOPHARYNGITIS (1562)


AMNESIA (1544)


INJECTION SITE PAIN (1540)


DYSPEPSIA (1536)


GASTROOESOPHAGEAL REFLUX DISEASE (1529)


CARDIAC FAILURE CONGESTIVE (1510)


BLOOD CREATININE INCREASED (1495)


ABDOMINAL DISTENSION (1467)


HYPERSENSITIVITY (1460)


CHILLS (1459)


EPISTAXIS (1422)


CARDIAC FAILURE (1404)


HYPOGLYCAEMIA (1402)


DIABETES MELLITUS (1388)


JOINT SWELLING (1379)


HALLUCINATION (1376)