RAVULIZUMAB

N/A

Manufactured by Alexion Pharmaceuticals Inc.

19,021 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RAVULIZUMAB

RAVULIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alexion Pharmaceuticals Inc.. The most commonly reported adverse reactions for RAVULIZUMAB include FATIGUE, ASTHENIA, HEADACHE, DRUG INEFFECTIVE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RAVULIZUMAB.

Top Adverse Reactions

FATIGUE1,571 reports
ASTHENIA778 reports
HEADACHE685 reports
DRUG INEFFECTIVE634 reports
OFF LABEL USE507 reports
DYSPNOEA446 reports
MUSCULAR WEAKNESS445 reports
MYASTHENIA GRAVIS396 reports
MALAISE385 reports
DEATH378 reports
HAEMOGLOBIN DECREASED366 reports
PAIN346 reports
BACK PAIN333 reports
FEELING ABNORMAL328 reports
THERAPEUTIC RESPONSE SHORTENED321 reports
DIPLOPIA315 reports
DIARRHOEA311 reports
NAUSEA298 reports
HAEMOLYSIS274 reports
ARTHRALGIA271 reports
DYSPHAGIA245 reports
DIZZINESS242 reports
EYELID PTOSIS241 reports
COVID 19240 reports
GAIT DISTURBANCE238 reports
SYMPTOM RECURRENCE235 reports
ILLNESS223 reports
PYREXIA223 reports
PAIN IN EXTREMITY220 reports
FALL219 reports
NASOPHARYNGITIS214 reports
URINARY TRACT INFECTION197 reports
PNEUMONIA192 reports
INFECTION186 reports
ANAEMIA177 reports
WEIGHT DECREASED167 reports
MUSCLE SPASMS160 reports
CONDITION AGGRAVATED158 reports
COUGH155 reports
SOMNOLENCE150 reports
BLOOD PRESSURE INCREASED147 reports
VOMITING143 reports
MYALGIA142 reports
PLATELET COUNT DECREASED140 reports
BREAKTHROUGH HAEMOLYSIS134 reports
GENERAL PHYSICAL HEALTH DETERIORATION132 reports
VISUAL IMPAIRMENT132 reports
BALANCE DISORDER129 reports
BLOOD LACTATE DEHYDROGENASE INCREASED128 reports
RASH126 reports
STRESS122 reports
POOR VENOUS ACCESS117 reports
VISION BLURRED117 reports
INFLUENZA116 reports
NECK PAIN115 reports
INSOMNIA113 reports
EXTRAVASCULAR HAEMOLYSIS111 reports
SPEECH DISORDER111 reports
ANXIETY110 reports
MYASTHENIA GRAVIS CRISIS109 reports
WEIGHT INCREASED106 reports
ABDOMINAL PAIN104 reports
ABDOMINAL DISCOMFORT101 reports
CHEST PAIN99 reports
SEPSIS97 reports
ABDOMINAL PAIN UPPER95 reports
INFUSION RELATED REACTION95 reports
PERIPHERAL SWELLING94 reports
PRODUCT DOSE OMISSION ISSUE93 reports
MUSCULOSKELETAL STIFFNESS91 reports
MEMORY IMPAIRMENT89 reports
PRURITUS89 reports
HYPOAESTHESIA88 reports
EXPOSURE DURING PREGNANCY84 reports
DYSPHONIA82 reports
DYSPNOEA EXERTIONAL80 reports
ALOPECIA74 reports
EYE DISORDER74 reports
DYSARTHRIA73 reports
MIGRAINE73 reports
MASTICATION DISORDER72 reports
CEREBROVASCULAR ACCIDENT70 reports
DECREASED APPETITE70 reports
CHEST DISCOMFORT68 reports
LABORATORY TEST ABNORMAL67 reports
CHILLS66 reports
SINUSITIS66 reports
SUSPECTED COVID 1966 reports
DIABETES MELLITUS64 reports
HYPERTENSION63 reports
TREMOR63 reports
RENAL IMPAIRMENT62 reports
DEPRESSION61 reports
INSURANCE ISSUE61 reports
NEUROMYELITIS OPTICA SPECTRUM DISORDER61 reports
THROMBOSIS60 reports
ATRIAL FIBRILLATION59 reports
CATARACT59 reports
MUSCULOSKELETAL DISCOMFORT59 reports
OROPHARYNGEAL PAIN59 reports

Report Outcomes

Out of 11,341 classified reports for RAVULIZUMAB:

Serious 49.4%Non-Serious 50.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,186 (53.8%)
Male4,447 (46.2%)

Reports by Age

Age 6071 reports
Age 7169 reports
Age 8068 reports
Age 7264 reports
Age 7564 reports
Age 7764 reports
Age 7362 reports
Age 6558 reports
Age 6958 reports
Age 6256 reports
Age 7056 reports
Age 8255 reports
Age 8154 reports
Age 6853 reports
Age 6352 reports
Age 6652 reports
Age 7650 reports
Age 6748 reports
Age 7447 reports
Age 6146 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with RAVULIZUMAB?

This profile reflects 19,021 FDA FAERS reports that mention RAVULIZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RAVULIZUMAB?

Frequently reported terms in FAERS include FATIGUE, ASTHENIA, HEADACHE, DRUG INEFFECTIVE, OFF LABEL USE, DYSPNOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RAVULIZUMAB?

Labeling and FAERS entries often list Alexion Pharmaceuticals Inc. in connection with RAVULIZUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.