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Selzentry Side Effects

Generic name: maraviroc

Medically reviewed by Drugs.com. Last updated on Aug 27, 2023.

Note: This document contains side effect information about maraviroc. Some dosage forms listed on this page may not apply to the brand name Selzentry.

Applies to maraviroc: oral solution, oral tablet.

Warning

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 Selzentry

Along with its needed effects, maraviroc (the active ingredient contained in Selzentry) 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

Less common

Incidence not known

Other side effects of Selzentry

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

Less common

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

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

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]

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]

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. Product Information. Selzentry (maraviroc). Pfizer U.S. Pharmaceuticals Group. 2007.

2. Fatkenheuer G, Pozniak AL, Johnson MA, et al. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med. 2005;11:1170-2.

3. Two new drugs for HIV infection. Med Lett Drugs Ther. 2008;50:2-4.

4. Cerner Multum, Inc. Australian Product Information.

5. Abel S, van der Ryst E, Rosario MC, et al. Assessment of the pharmacokinetics, safety and tolerability of maraviroc, a novel CCR5 antagonist, in healthy volunteers. Br J Clin Pharmacol. 2008;65 Suppl 1:5-18.

6. Lieberman-Blum SS, Fung HB, Bandres JC. Maraviroc: A CCR5-receptor antagonist for the treatment of HIV-1 infection. Clin Ther. 2008;30:1228-50.

7. Yost R, Pasquale TR, Sahloff EG. Maraviroc: A coreceptor CCR5 antagonist for management of HIV infection. Am J Health Syst Pharm. 2009;66:715-26.

8. Drugs for HIV infection. Treat Guidel Med Lett. 2009;7:11-22.

9. Panel on Antiretroviral Therapy and Medical Management. Guidelines for the use of antiretroviral agents in pediatric HIV infection. https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf 2017.

10. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf 2017.

11. Cerner Multum, Inc. UK Summary of Product Characteristics.

12. Anti-HIV agents. Maraviroc--coming soon. TreatmentUpdate. 2007;19:2-4.

13. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E. Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection. J Antimicrob Chemother. 2008;62:879-88.

14. Abel S, Russell D, Whitlock LA, Ridgway CE, Muirhead GJ. The effects of cotrimoxazole or tenofovir co-administration on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol. 2008;65 Suppl 1:47-53.

15. Macarthur RD, Novak RM. Maraviroc: The First of a New Class of Antiretroviral Agents. Clin Infect Dis. 2008;47:236-41.

Further information

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.