Selzentry Side Effects

Generic Name: maraviroc

Please note - some side effects for Selzentry may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Selzentry - for the Consumer

Selzentry

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 Selzentry:

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; chest pain; confusion; depression; fainting; fever, chills, or sore throat; flu-like symptoms; numbness or tingling of an arm or leg; one-sided weakness; seizures; severe muscle pain; severe or persistent stomach pain; shortness of breath; slurred speech; sores or white patches in the mouth; sudden, severe headache, vomiting, or dizziness; 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.

Selzentry Side Effects - for the Professional

Selzentry

The most common adverse reactions (>8% incidence) which occurred at a higher frequency compared to placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness (6).

Side Effects by Body System

General

The safety report of maraviroc is principally based on 840 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.

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.

Nervous system

Nervous system side effects have included dizziness/postural dizziness (9%), paresthesias and dysesthesias (5%), sensory abnormalities (4%), peripheral neuropathies (4%), and headache. Cerebrovascular accident, convulsions and epilepsy, and tremor (excluding congenital) 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.

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. Clostridium difficile colitis, infective myositis, viral meningitis, pneumonia, treponema infections, 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%).

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%). 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.

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%). Hepatic cirrhosis, hepatic failure, cholestatic jaundice, and portal vein thrombosis 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.

Oncologic

Oncologic side effects have included benign skin neoplasms (3%). Abdominal neoplasm, anal cancer, anaplastic large cell lymphomas (T- and null-types), malignant bile duct neoplasms, endocrine neoplasms (malignant and unspecified), basal cell carcinoma, Bowen's disease, cholangiocarcinoma, 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%). 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.

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