Danicopan Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.

Applies to danicopan: oral tablets film-coated.

Important warnings This medicine can cause some serious health issues

REMS:

FDA approved a REMS for danicopan to ensure that the benefits outweigh the risks.

The REMS may apply to one or more preparations of danicopan and consists of elements to assure safe use and implementation system.

See the FDA REMS page ([Web]) for specific information.

Side effects include:

Most frequently reported adverse effect (≥10%): headache.

For healthcare professionals

Applies to danicopan: oral tablet.

General adverse events

The most common adverse reaction occurring in 10% of patients or greater was headache.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension

Gastrointestinal

• Common (1% to 10%): Vomiting

Hepatic

• Very common (10% or more): Increased ALT (14%)

ALT elevations greater than 3 times the upper limit of normal (3 x ULN) and 5 x ULN or less occurred in 9% of treated patients.

ALT elevations greater than 5 x ULN and 10 x ULN or less occurred in 5% of treated patients.

Metabolic

• Very common (10% or more): Grade 1 hypercholesterolemia (30%), LDL cholesterol increased greater than 130 mg/dL and up to 160 mg/dL (13%)
• Common (1% to 10%): LDL cholesterol increased greater than 160 mg/dL and up to 190 mg/dL
• Frequency not reported: Increased serum triglycerides, increased total cholesterol, increased LDL cholesterol

Nervous system

• Very common (10% or more): Headache (11%)

Other

• Common (1% to 10%): Pyrexia, pain in extremity

Further information

Danicopan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer