Avacopan Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 9, 2023.

Applies to avacopan: oral capsule.

Serious side effects of avacopan

Along with its needed effects, avacopan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking avacopan:

More common

• bladder pain
• bloody or cloudy urine
• chest pain or tightness
• cough
• dark urine
• difficult, burning, or painful urination
• fever or chills
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• nausea or vomiting
• sneezing
• sore throat
• stomach pain, severe
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects of avacopan

Some side effects of avacopan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• dizziness
• headache
• skin rash

For Healthcare Professionals

Applies to avacopan: oral capsule.

General

The most common adverse reactions occurring in 5% of patients or greater included nausea, headache, diarrhea, vomiting, rash, upper abdominal pain, and dizziness.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (18%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (11%)
• Common (1% to 10%): Alopecia, pruritus, cellulitis, angioedema^[Ref]

Endocrine

• Common (1% to 10%): Cushingoid^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (24%), diarrhea (15%), vomiting (15%)
• Common (1% to 10%): Upper abdominal pain, constipation, dyspepsia, oral candidiasis, oral herpes, gastroenteritis^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Hematologic

• Very common (10% or more): Decreased white blood cell count (19%)
• Common (1% to 10%): Anemia, leukopenia, lymphopenia, neutropenia, increased tendency to bruise
• Uncommon (0.1% to 1%): Agranulocytosis^[Ref]

Hepatic

• Very common (10% or more): Increased liver function test (up to 13.3%)
• Frequency not reported: Hepatitis B reactivation^[Ref]

Increased liver function test (LFT) included elevated ALT and bilirubin, abnormal hepatic function, increased gamma-glutamyl transferase, increased hepatic enzyme, and increased transaminase. In another study increased LFT included hepatitis, hepatitis cholestasis, hepatocellular injury, asymptomatic hepatitis, cytolysis, and anicteric cholestasis without hepatocellular insufficiency.^[Ref]

Immunologic

• Very common (10% or more): ANCA-positive vasculitis (16%)^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (19%), muscle spasms (11%)
• Common (1% to 10%): Back pain, myalgia, pain in extremity^[Ref]

Nervous system

• Very common (10% or more): Headache (21%)
• Common (1% to 10%): Dizziness, paresthesia, tremor^[Ref]

Other

• Very common (10% or more): Peripheral edema (21%), fatigue (10%)
• Common (1% to 10%): Herpes zoster, bruising, increased creatine phosphokinase, pyrexia, otitis media
• Uncommon (0.1% to 1%): Weight increased^[Ref]

Renal

• Common (1% to 10%): Increased serum creatinine, acute kidney injury^[Ref]

Respiratory

• Very common (10% or more): Cough (16%), nasopharyngitis (15%), upper respiratory tract infection (15%)
• Common (1% to 10%): Pneumonia, sinusitis, oropharyngeal pain, bronchitis, epistaxis, dyspnea, lower respiratory tract infection, influenza, rhinitis^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia^[Ref]

Further information

Avacopan 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer