Maraviroc Side Effects
Medically reviewed by Drugs.com. Last updated on May 6, 2024.
Applies to maraviroc: oral solution, oral tablet.
Important Warnings
This medicine can cause some serious health issues
Oral route (Solution; Tablet)
Hepatotoxicity has been reported with use of maraviroc.
Severe rash or evidence of a systemic allergic reaction (eg, fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur.
Patients with signs or symptoms of hepatitis or allergic reaction following use of maraviroc should be evaluated immediately .
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
- 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]
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]
Hypersensitivity
- Frequency not reported: Delayed-type hypersensitivity reactions (including rash, fever, eosinophilia, liver reactions)
- Postmarketing reports: Severe hypersensitivity reactions[Ref]
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]
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
- 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]
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]
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]
References
1. (2007) "Product Information. Selzentry (maraviroc)." Pfizer U.S. Pharmaceuticals Group
2. Fatkenheuer G, Pozniak AL, Johnson MA, et al. (2005) "Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1." Nat Med, 11, p. 1170-2
3. (2008) "Two new drugs for HIV infection." Med Lett Drugs Ther, 50, p. 2-4
4. Cerner Multum, Inc. "Australian Product Information."
5. Abel S, van der Ryst E, Rosario MC, et al. (2008) "Assessment of the pharmacokinetics, safety and tolerability of maraviroc, a novel CCR5 antagonist, in healthy volunteers." Br J Clin Pharmacol, 65 Suppl 1, p. 5-18
6. Lieberman-Blum SS, Fung HB, Bandres JC (2008) "Maraviroc: A CCR5-receptor antagonist for the treatment of HIV-1 infection." Clin Ther, 30, p. 1228-50
7. Yost R, Pasquale TR, Sahloff EG (2009) "Maraviroc: A coreceptor CCR5 antagonist for management of HIV infection." Am J Health Syst Pharm, 66, p. 715-26
8. (2009) "Drugs for HIV infection." Treat Guidel Med Lett, 7, p. 11-22
9. Panel on Antiretroviral Therapy and Medical Management (2017) Guidelines for the use of antiretroviral agents in pediatric HIV infection. https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf
10. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC) (2017) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf
11. Cerner Multum, Inc. "UK Summary of Product Characteristics."
12. (2007) "Anti-HIV agents. Maraviroc--coming soon." TreatmentUpdate, 19, p. 2-4
13. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E (2008) "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother, 62, p. 879-88
14. Abel S, Russell D, Whitlock LA, Ridgway CE, Muirhead GJ (2008) "The effects of cotrimoxazole or tenofovir co-administration on the pharmacokinetics of maraviroc in healthy volunteers." Br J Clin Pharmacol, 65 Suppl 1, p. 47-53
15. Macarthur RD, Novak RM (2008) "Maraviroc: The First of a New Class of Antiretroviral Agents." Clin Infect Dis, 47, p. 236-41
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Further information
Maraviroc side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.