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, hypertension, white blood cell count decreased, diarrhea, vomiting, rash, fatigue, upper respiratory tract infection, upper abdominal pain, dizziness, liver function abnormalities, blood creatinine increased, nasopharyngitis, and paresthesia.[Ref]
Cardiovascular
Very common (10% or more): Hypertension (18%)[Ref]
Dermatologic
Very common (10% or more): Rash (11%)
Common (1% to 10%): Alopecia, pruritus, herpes zoster, cellulitis, angioedema (hypersensitivity reaction)[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): White blood cell count decreased (19%)
Common (1% to 10%): Anemia, leukopenia, lymphopenia, neutropenia, increased bruising
Uncommon (0.1% to 1%): Agranulocytosis[Ref]
Hepatic
Very common (10% or more): Hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzymes abnormalities (13.3%), liver function test increased, including alanine aminotransferase increased, total blood bilirubin increased, hepatic function abnormal, gamma glutamyl transferase increased, hepatic enzyme increased, transaminases increased (greater than 10%)
Common (1% to 10%): Hypercholesterolemia, hepatitis
Uncommon (0.1% to 1%): Hepatitis cholestatic, hepatocellular injury
Frequency not reported: Hepatitis B reactivation[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, increased creatine phosphokinase[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%): Pyrexia
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]
