Maraviroc Side Effects

Some side effects of maraviroc may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to maraviroc: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking maraviroc: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Maraviroc may also cause an allergic reaction with severe liver symptoms. Stop taking maraviroc and call your doctor at once if you have:

• fever, itching or rash;

• vomiting, upper stomach pain; or

• dark urine, jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have a side effect such as:

• a light-headed feeling, like you might pass out;

• chest pressure, tight feeling in your neck or jaw, sweating, pain spreading to your arm or shoulder; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Maraviroc may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with maraviroc. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• dizziness; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to maraviroc: oral tablet

General

The most common side effects reported with twice-daily treatment were cough, pyrexia, upper respiratory tract infections, rash, and dizziness. The most common side effects reported with once-daily dosing were diarrhea, edema, influenza, esophageal candidiasis, sleep disorders, rhinitis, parasomnias, and urinary abnormalities.

Respiratory

Very common (10% or more): Upper respiratory tract infection (23% to 32%), coughing and associated symptoms (14%), bronchitis (7% to 13%)
Common (1% to 10%): Upper respiratory tract signs and symptoms (9%), sinusitis (7%), upper respiratory tract signs and symptoms (6%), nasal congestion and inflammations (4%), breathing abnormalities (4%), paranasal sinus disorders (3%), lower respiratory tract and lung infections (3%), pneumonia (2% or less), influenza (2%)
Frequency not reported: Rhinitis, bronchospasm and obstruction, respiratory tract disorders, epistaxis

Other

Very common (10% or more): Pyrexia (13%)
Common (1% to 10%): Herpes infection (7% to 8%), bacterial infections NEC (6%), herpes zoster/varicella (5%), pain and discomfort (4%), Neisseria infections (3%), viral infections NEC (3%), body temperature perception (3%), ear disorders NEC (3%), otitis media (2%), treponema infections (less than 2%), septic shock (less than 2%)
Frequency not reported: Edema, fatigue, asthenia, hot flushes, condyloma acuminatum

Dermatologic

Severe, potentially life-threatening skin and hypersensitivity reactions were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In most cases, maraviroc was coadministered with other drugs associated with such reactions.

Very common (10% or more): Rash (11%)
Common (1% to 10%): Nail and nail bed conditions (excluding infections and infestations; 6%), apocrine and eccrine gland disorders (5%), pruritus (4%), folliculitis (4%), tinea infections (4%), lipodystrophies (3% to 4%), acnes (3%), erythemas (2%), alopecias (2%)
Frequency not reported: Dermatitis, eczema
Postmarketing reports: Severe skin reactions (including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms [DRESS], toxic epidermal necrolysis)

Hypersensitivity

Severe, potentially life-threatening skin and hypersensitivity reactions were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In most cases, maraviroc was coadministered with other drugs associated with such reactions.

Postmarketing reports: Severe hypersensitivity reactions

Gastrointestinal

Very common (10% or more): Flatulence, bloating, and distention (10%)
Common (1% to 10%): Gastrointestinal atonic and hypomotility disorders NEC (9%), constipation (6%), gastrointestinal signs and symptoms NEC (3%), Clostridium difficile colitis (less than 2%)
Frequency not reported: Diarrhea, esophageal candidiasis, gastrointestinal and abdominal pains, dyspeptic signs/symptoms, ulceration stomatitis, nausea, gingivitis, dry mouth, flatulence, vomiting

Nervous system

Common (1% to 10%): Dizziness/postural dizziness (9%), paresthesias and dysesthesias (4% to 5%), sensory abnormalities (4%), disturbances in consciousness (4%), peripheral neuropathies (4%), memory loss (excluding dementia; 3%), cerebrovascular accident (less than 2%), convulsions and epilepsy (less than 2%), tremor (excluding congenital; less than 2%), facial palsy (less than 2%), hemianopia (less than 2%), loss of consciousness (less than 2%), viral meningitis (less than 2%), meningitis (less than 2%), visual field defect (less than 2%)
Frequency not reported: Headache, sleep disorders

Hematologic

Common (1% to 10%): Anemias NEC (8%), decreased absolute neutrophil count (less than 750/mm3; 5.7%), decreased absolute neutrophil count (less than 750/mm3; 4.3%), neutropenias (4%), decreased hemoglobin (less than 7 g/dL; 2.9%), marrow depression (less than 2%), hypoplastic anemia (less than 2%)

Metabolic

Common (1% to 10%): Appetite disorders (8%), elevated amylase (greater than 2 times ULN; 4.3% to 5.7%), elevated lipase (greater than 2 times ULN; 4.9%), elevated creatine kinase (3.9%)
Frequency not reported: Unintentional weight loss (wasting), hyperlipidemia

Psychiatric

Common (1% to 10%): Disturbances in initiating and maintaining sleep (8%), depressive disorders (4%), anxiety symptoms (4%)
Frequency not reported: Parasomnias, somnolence

Musculoskeletal

Common (1% to 10%): Joint-related signs and symptoms (6% to 7%), muscle pains (3%), myositis (less than 2%), infective myositis (less than 2%), osteonecrosis (less than 2%), rhabdomyolysis (less than 2%), increased blood creatine kinase (less than 2%)

Hepatic

Common (1% to 10%): Elevated total bilirubin (greater than 5 times ULN; 5.5%), elevated aspartate transaminase (greater than 5 times ULN; 4% to 4.8%), elevated alanine transaminase (greater than 5 times ULN; 2.6% to 3.9%), hepatic cirrhosis (less than 2%), hepatic failure (less than 2%), cholestatic jaundice (less than 2%), portal vein thrombosis (less than 2%), hypertransaminasemia (less than 2%), jaundice (less than 2%)
Frequency not reported: Hepatotoxicity (sometimes associated with rash and eosinophilia)

Genitourinary

Common (1% to 10%): Bladder and urethral symptoms (4% to 5%), urinary tract signs and symptoms (3%), erection and ejaculation conditions and disorders (3%), anogenital warts (2%)
Frequency not reported: Urinary abnormalities

Cardiovascular

Common (1% to 10%): Vascular hypertensive disorders (3%), unstable angina (less than 2%), acute cardiac failure (less than 2%), coronary artery disease (less than 2%), coronary artery occlusion (less than 2%), endocarditis (less than 2%), myocardial infarction (less than 2%), myocardial ischemia (less than 2%)
Frequency not reported: Postural hypotension, arrhythmia

Oncologic

Common (1% to 10%): Skin neoplasms (3%), abdominal neoplasm (less than 2%), anal cancer (less than 2%), anaplastic large cell lymphomas (T- and null-cell types; less than 2%), malignant bile duct neoplasms (less than 2%), endocrine neoplasms (malignant and unspecified; less than 2%), basal cell carcinoma (less than 2%), Bowen's disease (less than 2%), cholangiocarcinoma (less than 2%), diffuse large B-cell lymphoma (less than 2%), lymphoma (less than 2%), metastases to liver (less than 2%), esophageal carcinoma (less than 2%), nasopharyngeal carcinoma (less than 2%), squamous cell carcinoma (less than 2%), squamous cell carcinoma of skin (less than 2%), tongue neoplasm (unspecified malignant stage; less than 2%)

Ocular

Common (1% to 10%): Conjunctivitis (2%), ocular infections, inflammations, and associated manifestations (2%)
Frequency not reported: Abnormal vision, eye pain

Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome)

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