Maraviroc Side Effects

Brand Names: Selzentry

Please note - some side effects for Maraviroc may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Maraviroc - for the Consumer

Maraviroc

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Maraviroc:

Constipation; cough; diarrhea; dizziness; muscle or joint pain; runny nose; sinus inflammation; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; burning, numbness, or tingling; chest, jaw, or left arm pain; confusion; depression; difficult or painful urination; fainting; fever, chills, or sore throat; flu-like symptoms; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe muscle pain; severe or persistent dizziness; severe or persistent stomach pain; shortness of breath; slurred speech; sores or white patches in the mouth; sudden, severe headache or vomiting; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, nausea, unusual tiredness, vomiting); unusual lumps, skin growths, or skin changes; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

The safety report of maraviroc is principally based on 840 treatment-experienced HIV-infected patients receiving at least one dose of maraviroc during two Phase 3 trials. Of these patients, 426 received the indicated twice daily dosing regimen.

The most common side effects reported with maraviroc twice daily treatment, regardless of causality, were cough, pyrexia, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness. Additional side effects reported with once daily dosing were diarrhea, edema, influenza, esophageal candidiasis, sleep disorders, rhinitis, parasomnias, and urinary abnormalities. In the two studies, discontinuations due to side effects were 5% in patients receiving maraviroc twice daily plus optimized background therapy (OBT) compared to 5% in those receiving placebo plus OBT. Most of the side effects reported were considered mild to moderate in severity.

Treatment-emergent side effects, regardless of causality, from a controlled study of 721 treatment-naive subjects have also been included.

Cardiovascular

Cardiovascular side effects have included vascular hypertensive disorders (3%) and arrhythmia. Unstable angina, acute cardiac failure, coronary artery disease, coronary artery occlusion, endocarditis, myocardial infarction, and myocardial ischemia have been reported in less than 2% of patients. Postural hypotension has been reported.

Respiratory

Respiratory side effects have included coughing and associated symptoms (14%), upper respiratory tract signs and symptoms (6%), nasal congestion and inflammations (4%), breathing abnormalities (4%), bronchospasm and obstruction (2.1%), paranasal sinus disorders (3%), respiratory tract disorders (2.1%), and epistaxis. Upper respiratory tract signs and symptoms (9%) have been reported in treatment-naive patients.

Nervous system

Nervous system side effects have included dizziness/postural dizziness (9%), paresthesias and dysesthesias (5%), sensory abnormalities (4%), peripheral neuropathies (4%), and headache. Paresthesias and dysesthesias (4%), memory loss (excluding dementia; 3%), and ear disorders NEC (3%) have been reported in treatment-naive patients. Cerebrovascular accident, convulsions and epilepsy, tremor (excluding congenital), facial palsy, hemianopia, loss of consciousness, and visual field defect have been reported in less than 2% of patients.

Other

Other side effects have included pyrexia (13%), pain and discomfort (4%), edema, fatigue, asthenia, and hot flushes. Body temperature perception (3%) has been reported in treatment-naive patients.

Immunologic

Immunologic side effects have included upper respiratory tract infection (including upper respiratory tract infection, laryngitis, laryngopharyngitis, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, viral respiratory tract infection; 23%), Herpes simplex infection (including Herpes simplex, Herpes virus, Herpes ophthalmic, proctitis Herpes; 8%), sinusitis (including sinusitis, acute sinusitis, chronic sinusitis, sinobronchitis; 7%), bronchitis (including bronchitis, acute bronchitis, bacterial bronchitis; 7%), folliculitis (4%), condyloma acuminatum (2%), pneumonia (including pneumonia, lobar pneumonia, bacterial pneumonia, bronchopneumonia; 2%), otitis media (2%), influenza (including influenza, influenza-like illness; 2%), and esophageal candidiasis. Upper respiratory tract infection (32%), bronchitis (13%), herpes infection (7%), bacterial infections NEC (6%), herpes zoster/varicella (5%), tinea infections (4%), lower respiratory tract and lung infections (3%), Neisseria infections (3%), and viral infections NEC (3%) have been reported in treatment-naive patients. Clostridium difficile colitis, infective myositis, viral meningitis, pneumonia, treponema infections, meningitis, and septic shock have been reported in less than 2% of patients.

Dermatologic

Dermatologic side effects have included rash (11%), apocrine and eccrine gland disorders (5%), pruritus (4%), dermatitis and eczema (3.1%), lipodystrophies (3%), and erythemas (2%). Nail and nail bed conditions (excluding infections and infestations; 6%), lipodystrophies (4%), acnes (3%), and alopecias (2%) have been reported in treatment-naive patients. Stevens-Johnson syndrome has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal and connective tissue signs and symptoms (8.7%), joint related signs and symptoms (7%), and muscle pains (3%). Joint related signs and symptoms (6%) have been reported in treatment-naive patients. Myositis, osteonecrosis, rhabdomyolysis, and increased blood creatine kinase have been reported in less than 2% of patients.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal and abdominal pains (8.2%), constipation (6%), dyspeptic signs/symptoms (2.8%), ulceration stomatitis (2.6%), diarrhea, nausea, gingivitis, dry mouth, flatulence, and vomiting. Flatulence, bloating, and distention (10%), gastrointestinal atonic and hypomotility disorders NEC (9%), and gastrointestinal signs and symptoms NEC (3%) have been reported in treatment-naive patients.

Hepatic

Hepatic side effects have included elevated aspartate transaminase (greater than 5 times ULN; 4.8%), alanine transaminase (greater than 5 times ULN; 2.6%), and total bilirubin (greater than 5 times ULN; 5.5%). Elevated aspartate transaminase (greater than 5 times ULN; 4%) and alanine transaminase (greater than 5 times ULN; 3.9%) have been reported in treatment-naive patients. Hepatic cirrhosis, hepatic failure, cholestatic jaundice, portal vein thrombosis, hypertransaminasemia, and jaundice have been reported in less than 2% of patients. Hepatotoxicity, sometimes associated with rash and eosinophilia, has been reported.

Psychiatric

Psychiatric side effects have included disturbances in initiating and maintaining sleep (8%), disturbances in consciousness (4%), depressive disorders (4%), anxiety symptoms (4%), parasomnias, and somnolence.

Metabolic

Metabolic side effects have included appetite disorders (8%), elevated amylase (greater than 2 times ULN; 5.7%), elevated lipase (greater than 2 times ULN; 4.9%), unintentional weight loss (wasting), and hyperlipidemia. Elevated amylase (greater than 2 times ULN: 4.3%) and creatine kinase (3.9%) have been reported in treatment-naive patients.

Oncologic

Oncologic side effects have included benign skin neoplasms (3%). Abdominal neoplasm, anal cancer, anaplastic large cell lymphomas (T- and null-cell types), malignant bile duct neoplasms, endocrine neoplasms (malignant and unspecified), basal cell carcinoma, Bowen's disease, cholangiocarcinoma, diffuse large B-cell lymphoma, lymphoma, metastases to liver, esophageal carcinoma, squamous cell carcinoma, squamous cell carcinoma of skin, and tongue neoplasm (unspecified malignant stage) have been reported in less than 2% of patients.

Hematologic

Hematologic side effects have included decreased absolute neutrophil count (less than 750/mm3; 4.3%). Anemias NEC (8%), decreased absolute neutrophil count (less than 750/mm3; 5.7%), decreased hemoglobin (less than 7 g/dL; 2.9%), and neutropenias (4%) have been reported in treatment-naive patients. Marrow depression and hypoplastic anemia have been reported in less than 2% of patients.

Genitourinary

Genitourinary side effects have included bladder and urethral symptoms (5%), urinary tract signs and symptoms (3%), and urinary abnormalities. Bladder and urethral symptoms (4%) and erection and ejaculation conditions and disorders (3%) have been reported in treatment-naive patients.

Ocular

Ocular side effects have included conjunctivitis (2%), ocular infections, inflammations, and associated manifestations (2%), abnormal vision, and eye pain.

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