Avacopan Side Effects

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

Applies to avacopan: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, hepatitis B).

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

This medicine may increase your risk of developing infections during or after treatment with this medicine. Avoid being near people who are sick or have infections while you are receiving this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start receiving this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to avacopan: oral capsule.

General adverse events

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]

See also:

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.

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