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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 (10146)


NAUSEA (9891)


DYSPNOEA (9832)


DRUG INEFFECTIVE (9152)


DIZZINESS (8718)


DIARRHOEA (8582)


ASTHENIA (7328)


FALL (7193)


MYALGIA (7028)


PAIN (7003)


HEADACHE (6575)


DRUG INTERACTION (6012)


VOMITING (6003)


MALAISE (5877)


PAIN IN EXTREMITY (5867)


ARTHRALGIA (5565)


RHABDOMYOLYSIS (4824)


PNEUMONIA (4810)


WEIGHT DECREASED (4662)


MYOCARDIAL INFARCTION (4580)


RENAL FAILURE (4551)


ACUTE KIDNEY INJURY (4386)


CHEST PAIN (4337)


DEATH (4171)


HYPOTENSION (4146)


RASH (4085)


PRURITUS (4063)


INSOMNIA (3976)


ANAEMIA (3953)


COUGH (3951)


HYPERTENSION (3843)


CONFUSIONAL STATE (3814)


DEPRESSION (3768)


OFF LABEL USE (3762)


BACK PAIN (3749)


CEREBROVASCULAR ACCIDENT (3723)


ANXIETY (3693)


GAIT DISTURBANCE (3656)


MUSCLE SPASMS (3634)


PYREXIA (3574)


BLOOD GLUCOSE INCREASED (3425)


DECREASED APPETITE (3418)


RENAL FAILURE ACUTE (3364)


CONSTIPATION (3340)


OEDEMA PERIPHERAL (3327)


CHRONIC KIDNEY DISEASE (3294)


MUSCULAR WEAKNESS (3256)


FEELING ABNORMAL (3132)


GASTROINTESTINAL HAEMORRHAGE (3046)


ABDOMINAL PAIN (3032)


ATRIAL FIBRILLATION (2977)


DEHYDRATION (2976)


URINARY TRACT INFECTION (2912)


FLUSHING (2807)


WEIGHT INCREASED (2724)


SYNCOPE (2696)


SOMNOLENCE (2695)


ABDOMINAL PAIN UPPER (2684)


CARDIAC FAILURE CONGESTIVE (2684)


PARAESTHESIA (2646)


CONDITION AGGRAVATED (2634)


TREMOR (2475)


BLOOD PRESSURE INCREASED (2425)


DRUG HYPERSENSITIVITY (2385)


ALOPECIA (2264)


HYPOAESTHESIA (2259)


HYPERHIDROSIS (2245)


LOSS OF CONSCIOUSNESS (2238)


BLOOD CREATINE PHOSPHOKINASE INCREASED (2161)


DRUG DOSE OMISSION (2160)


HAEMOGLOBIN DECREASED (2110)


BALANCE DISORDER (2048)


GENERAL PHYSICAL HEALTH DETERIORATION (2026)


ERYTHEMA (2005)


MEMORY IMPAIRMENT (1989)


VISION BLURRED (1928)


CORONARY ARTERY DISEASE (1917)


ABDOMINAL DISCOMFORT (1890)


CONTUSION (1847)


SEPSIS (1840)


DIABETES MELLITUS (1832)


HYPONATRAEMIA (1791)


PALPITATIONS (1779)


RENAL IMPAIRMENT (1773)


BLOOD CREATININE INCREASED (1771)


DYSPEPSIA (1768)


PERIPHERAL SWELLING (1732)


INJECTION SITE PAIN (1706)


GASTROOESOPHAGEAL REFLUX DISEASE (1682)


NASOPHARYNGITIS (1631)


HYPERSENSITIVITY (1611)


EPISTAXIS (1588)


DYSPHAGIA (1561)


PRODUCT QUALITY ISSUE (1560)


CHEST DISCOMFORT (1545)


BLOOD CHOLESTEROL INCREASED (1538)


HYPOGLYCAEMIA (1532)


CARDIAC DISORDER (1523)


AMNESIA (1505)


CHILLS (1484)