Maraviroc Side Effects

It is possible that some side effects of maraviroc may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to maraviroc: oral tablet

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
  • difficulty with breathing
  • 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
  • shortness of breath or troubled breathing
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain or tenderness
  • 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
  • convulsions
  • dark-colored urine
  • diarrhea
  • dilated neck veins
  • discharge or excessive tearing
  • dizziness
  • drowsiness
  • earache
  • extreme fatigue
  • eye pain
  • fast, weak pulse
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • heavy jaw feeling
  • inability to speak
  • increased frequency of urination
  • irregular breathing
  • itching
  • 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, pains, or stiffness
  • muscle cramps or spasms
  • 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
  • rash
  • redness or swelling in the ear
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sensitivity of the eye to light
  • severe abdominal or stomach cramps and pain
  • 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 lumps
  • stomach pain, continuing
  • 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
  • troubled breathing with exertion
  • 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
  • weight loss
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • cough
  • muscle pain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips

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 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.

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, pneumonia, influenza
Frequency not reported: Rhinitis, bronchospasm and obstruction, respiratory tract disorders, epistaxis

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
Frequency not reported: Edema, fatigue, hot flushes, condyloma acuminatum, treponema infections, septic shock

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.

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, erythemas, alopecias
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

Postmarketing reports: Severe hypersensitivity reactions

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.

Gastrointestinal

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

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, Clostridium difficile colitis

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

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.

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

Metabolic

Common (1% to 10%): Appetite disorders, anorexia
Rare (0.01% to 0.1%): Increased alkaline phosphatase
Frequency not reported: Unintentional weight loss (wasting), hyperlipidemia

Psychiatric

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

Musculoskeletal

Common (1% to 10%): Joint-related signs/symptoms, elevated creatine kinase, muscle pains
Uncommon (0.1% to 1%): Myositis, increased blood creatine phosphokinase
Rare (0.01% to 0.1%): Muscle atrophy
Frequency not reported: Infective myositis, osteonecrosis, rhabdomyolysis

Elevated creatine kinase (greater than 10 to 20 times ULN: 2.8%; greater than 20 times ULN: 1.1%) has been reported.

Hepatic

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

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

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

Cardiovascular

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

Oncologic

Common (1% to 10%): 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, lymphoma, squamous cell carcinoma, squamous cell carcinoma of skin, tongue neoplasm (unspecified malignant stage)

Ocular

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

Renal

Uncommon (0.1% to 1%): Renal failure

Immunologic

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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