Summary

Commonly reported side effects of maraviroc include: upper respiratory tract infection, fever, and skin rash. Continue reading for a comprehensive list of adverse effects.

Applies to maraviroc: oral solution, oral tablet.

Serious side effects of Maraviroc

Along with its needed effects, maraviroc 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 maraviroc:

More common

• Body aches or pain
• burning or stinging of the skin
• chills
• cough producing mucus
• coughing
• dizziness when getting up suddenly from a lying or sitting position
• ear congestion
• headache
• loss of voice
• pain or tenderness around the eyes and cheekbones
• painful blisters on the trunk of the body
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest
• trouble breathing
• unusual tiredness or weakness

Less common

• Arm, back, or jaw pain
• black, tarry stools
• blood in the urine
• blurred or double vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• burning, itching, and pain in the hairy areas, pus at the root of the hair
• change in consciousness
• chest pain, discomfort, or heaviness
• choking
• clay-colored stools
• cold, clammy skin
• confusion
• dark-colored urine
• diarrhea
• dilated neck veins
• discharge or excessive tearing
• dizziness
• drowsiness
• earache
• eye pain
• fast, weak pulse
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• heavy jaw feeling
• inability to speak
• increased frequency of urination
• irregular breathing
• itching or rash
• joint pain
• light-colored stools
• lightheadedness
• loosening of a tooth
• loss of appetite
• loss of bladder control
• loss of taste
• lumps in the tongue
• muscle aches, cramps, pains, spasms, or stiffness
• nausea or vomiting
• nervousness
• noisy breathing
• pain or burning during urination
• pain or discomfort in the arms, jaw, back, or neck
• pain, swelling, or numbness in the mouth or jaw
• pale skin
• pounding in the ears
• redness or swelling in the ear
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• seizures
• sensitivity of the eye to light
• severe or sudden headache
• shakiness in the legs, arms, hands, or feet
• shivering
• skin lumps
• slow, fast, or irregular heartbeat
• slurred speech
• spread of cancer to the liver
• stiff neck or back
• stomach cramps, lumps, pain, or tenderness
• sudden loss of consciousness
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• tearing
• temporary blindness
• trembling or shaking of the hands or feet
• trouble sleeping
• unable to speak
• unpleasant breath odor
• unsteadiness or awkwardness
• unusual bleeding or bruising
• vomiting of blood
• warts on the genital area
• watery and severe diarrhea, which may also be bloody
• weakness in the arms, hands, legs, or feet
• weakness on one side of the body, sudden and severe
• weight gain or loss
• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• cough
• muscle pain
• red irritated eyes
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips

Other side effects of Maraviroc

Some side effects of maraviroc 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

• Difficulty having a bowel movement (stool)
• difficulty with moving
• increased or decreased appetite
• swelling or redness in the joints

Less common

• Acid or sour stomach
• belching
• blistering, crusting, irritation, or reddening of the skin
• canker sores
• discouragement
• feeling sad or empty
• flushing or redness of the skin
• heartburn
• indigestion
• irritability
• loss of interest or pleasure
• redistribution or accumulation of body fat
• skin rash, encrusted, scaly, and oozing
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach discomfort or upset
• tiredness
• trouble in concentrating
• unusually warm skin

For Healthcare Professionals

Applies to maraviroc: oral liquid, 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. Nausea, diarrhea, fatigue, and headache were common in phase 2b/3 trials.^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 32%), coughing and associated symptoms (14%), bronchitis (up to 13%)

Common (1% to 10%): Upper respiratory tract signs/symptoms, sinusitis, upper respiratory tract signs/symptoms, nasal congestion and inflammations, breathing abnormalities, paranasal sinus disorders, lower respiratory tract and lung infections, influenza

Uncommon (0.1% to 1%): Pneumonia

Frequency not reported: Rhinitis, bronchospasm and obstruction, respiratory tract disorders, epistaxis^[Ref]

Other

Very common (10% or more): Pyrexia (13%)

Common (1% to 10%): Asthenia, herpes infection, bacterial infections, herpes zoster/varicella, pain and discomfort, Neisseria infections, viral infections, body temperature perception, ear disorders, otitis media

Rare (0.01% to 0.1%): Increased alkaline phosphatase

Frequency not reported: Edema, fatigue, hot flushes, treponema infections, septic shock, serious infections^[Ref]

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, other drugs associated with such reactions were coadministered.^[Ref]

Very common (10% or more): Rash (up to 11%)

Common (1% to 10%): Nail and nail bed conditions (excluding infections and infestations), apocrine and eccrine gland disorders, pruritus, folliculitis, tinea infections, lipodystrophies, acnes, erythema, alopecias

Frequency not reported: Dermatitis, eczema

Postmarketing reports: Severe skin reactions, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis^[Ref]

Hypersensitivity

Delayed-type hypersensitivity reactions generally occurred within 2 to 6 weeks after start of therapy; such reactions included rash, fever, eosinophilia, and liver reactions. Skin and liver reaction occurred as single events and in combination.

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

Frequency not reported: Delayed-type hypersensitivity reactions (including rash, fever, eosinophilia, liver reactions)

Postmarketing reports: Severe hypersensitivity reactions^[Ref]

Gastrointestinal

Very common (10% or more): Flatulence, bloating, and distention (10%)

Common (1% to 10%): Gastrointestinal atonic and hypomotility disorders, constipation, elevated amylase, elevated lipase, gastrointestinal signs/symptoms, abdominal pain, flatulence, nausea

Uncommon (0.1% to 1%): Esophageal candidiasis

Frequency not reported: Diarrhea, gastrointestinal pain, dyspeptic signs/symptoms, ulceration stomatitis, gingivitis, dry mouth, vomiting, Clostridioides difficile colitis^[Ref]

Elevated amylase (greater than 2 to 5 times the upper limit of normal [2 to 5 x ULN]: up to 5.7%; greater than 5 x ULN: up to 0.3%) and elevated lipase (greater than 2 to 5 x ULN: 5%; greater than 5 x ULN: 1.3%) have been reported.^[Ref]

Nervous system

Common (1% to 10%): Dizziness/postural dizziness, paresthesias and dysesthesias, sensory abnormalities, disturbances in consciousness, peripheral neuropathies, memory loss (excluding dementia)

Uncommon (0.1% to 1%): Seizures and seizure disorders/convulsions and epilepsy

Frequency not reported: Headache, sleep disorders, syncope, cerebrovascular accident, tremor (excluding congenital), facial palsy, hemianopia, loss of consciousness, viral meningitis, meningitis, visual field defect^[Ref]

Hematologic

Decreased absolute neutrophil count (500 to 749/mm3: up to 4.3%; less than 500/mm3: up to 1.4%) and decreased hemoglobin (6.5 to 6.9 g/dL: 0.6%; less than 6.5 g/dL: 2.3%) have been reported.^[Ref]

Common (1% to 10%): Anemias, decreased absolute neutrophil count, neutropenias, decreased hemoglobin

Rare (0.01% to 0.1%): Pancytopenia, granulocytopenia

Frequency not reported: Marrow depression, hypoplastic anemia^[Ref]

Metabolic

Common (1% to 10%): Appetite disorders, anorexia

Frequency not reported: Unintentional weight loss (wasting), hyperlipidemia^[Ref]

Psychiatric

Common (1% to 10%): Disturbances in initiating and maintaining sleep/insomnia, depressive disorders/depression, anxiety symptoms

Frequency not reported: Parasomnias, somnolence^[Ref]

Musculoskeletal

Common (1% to 10%): Joint-related signs/symptoms, elevated creatine phosphokinase (CPK), muscle pains

Uncommon (0.1% to 1%): Myositis

Rare (0.01% to 0.1%): Muscle atrophy

Frequency not reported: Infective myositis, osteonecrosis, rhabdomyolysis^[Ref]

Elevated CPK (greater than 10 x ULN: 3.9%; greater than 10 to 20 x ULN: 2.8%; greater than 20 x ULN: 1.1%) has been reported.^[Ref]

Hepatic

Common (1% to 10%): Elevated total bilirubin, elevated AST, elevated ALT

Uncommon (0.1% to 1%): Hyperbilirubinemia, elevated GGT

Rare (0.01% to 0.1%): Toxic hepatitis, hepatic failure, hepatic cirrhosis

Very rare (less than 0.01%): Hepatic failure with allergic features

Frequency not reported: Hepatotoxicity (sometimes associated with rash and eosinophilia), cholestatic jaundice, portal vein thrombosis, hypertransaminasemia, jaundice^[Ref]

Elevated total bilirubin (greater than 2 to 5 x ULN: 5%; greater than 5 x ULN: 5.5%), elevated AST (greater than 5 x ULN: up to 4.8%; greater than 10 x ULN: up to 1.7%), and elevated ALT (greater than 5 x ULN: up to 3.9%; greater than 10 x ULN: up to 1%) have been reported.^[Ref]

Genitourinary

Common (1% to 10%): Bladder and urethral symptoms, urinary tract signs/symptoms, erection and ejaculation conditions and disorders, anogenital warts

Uncommon (0.1% to 1%): Proteinuria

Frequency not reported: Urinary abnormalities^[Ref]

Cardiovascular

Common (1% to 10%): Vascular hypertensive disorders

Uncommon (0.1% to 1%): Postural hypotension

Rare (0.01% to 0.1%): Angina pectoris

Frequency not reported: Postural/orthostatic hypotension, arrhythmia, unstable angina, acute cardiac failure, coronary artery disease, coronary artery occlusion, endocarditis, myocardial infarction, myocardial ischemia^[Ref]

Oncologic

Common (1% to 10%): Benign skin neoplasms

Rare (0.01% to 0.1%): Malignant bile duct neoplasms/bile duct cancer, diffuse large B-cell lymphoma, Hodgkin's disease, metastases to bone, metastases to liver, metastases to peritoneum, esophageal carcinoma, nasopharyngeal carcinoma/cancer

Frequency not reported: Abdominal neoplasm, anal cancer, anaplastic large cell lymphomas (T- and null-cell types), endocrine neoplasms (malignant and unspecified), basal cell carcinoma, Bowen's disease, cholangiocarcinoma, condyloma acuminatum, lymphoma, squamous cell carcinoma, squamous cell carcinoma of skin, tongue neoplasm (unspecified malignant stage), malignancies^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis; ocular infections, inflammations, and associated manifestations

Frequency not reported: Abnormal vision, eye pain^[Ref]

Renal

Uncommon (0.1% to 1%): Renal failure^[Ref]

Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis), AIDS-related events^[Ref]