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.
See also:
For healthcare professionals
Applies to danicopan: oral tablet.
General adverse events
The most common adverse reactions included headache, diarrhea, and increased lipid parameters and/or liver enzymes.[Ref]
Cardiovascular
- Common (1% to 10%): Hypertension
Gastrointestinal
- Very common (10% or more): Diarrhea (11.3%)
- Common (1% to 10%): Vomiting, nausea
- Rare (0.01% to 0.1%): Pancreatitis, cholecystitis
Hepatic
- Very common (10% or more): Increased ALT (14%)
- Rare (0.01% to 0.1%): Increased blood bilirubin, increased AST, increased hepatic enzymes
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%), increased LDL cholesterol greater than 130 mg/dL and up to 160 mg/dL (13%)
- Common (1% to 10%): Increased LDL cholesterol greater than 160 mg/dL and up to 190 mg/dL
- Frequency not reported: Increased serum triglycerides, increased total cholesterol, increased LDL cholesterol
Musculoskeletal
- Common (1% to 10%): Arthralgia, pain in extremity
Nervous system
- Very common (10% or more): Headache (11%)
Other
- Common (1% to 10%): Pyrexia, asthenia, fatigue
References
1. (2024) "Product Information. Voydeya (danicopan)." Alexion Pharmaceuticals Inc
2. (2024) "Product Information. Voydeya (danicopan)." Alexion Pharmaceuticals Australasia Pty Ltd, CCDS v5.0
More about danicopan
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- Drug class: selective immunosuppressants
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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.