May 29, 2017
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Hypersensitivity Reactions

Inform patients that potentially life-threatening hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome) can occur while receiving RETROVIR. Instruct patients to immediately contact their healthcare provider if they develop rash, as it may be a sign of a more serious reaction. Advise patients that it is very important that they remain under a healthcare provider's care during treatment with RETROVIR [see CONTRAINDICATIONS].

Neutropenia And Anemia

Inform patients that the major toxicities of RETROVIR are neutropenia and/or anemia. The frequency and severity of these toxicities are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection. Advise patients that if toxicity develops, they may require transfusions or drug discontinuation. Advise patients of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced symptomatic HIV-1 disease [see BOXED WARNING, WARNINGS AND PRECAUTIONS].


Inform patients that myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of RETROVIR [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Lactic Acidosis/Hepatomegaly With Steatosis

Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking RETROVIR if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

HIV-1/HCV Co-infection

Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see WARNINGS AND PRECAUTIONS].

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when RETROVIR is started [see WARNINGS AND PRECAUTIONS].

Redistribution/Accumulation Of Body Fat

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see WARNINGS AND PRECAUTIONS].

Common Adverse Reactions

Inform patients that the most commonly reported adverse reactions in adult patients being treated with RETROVIR were headache, malaise, nausea, anorexia, and vomiting. The most commonly reported adverse reactions in pediatric patients receiving RETROVIR were fever, cough, and digestive disorders. Patients also should be encouraged to contact their physician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events while being treated with RETROVIR [see ADVERSE REACTIONS].

Drug Interactions

Advise patients that other medications may interact with RETROVIR and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of RETROVIR [see DRUG INTERACTIONS].


Inform pregnant women considering the use of RETROVIR during pregnancy for prevention of HIV-1 transmission to their infants that transmission may still occur in some cases despite therapy.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RETROVIR during pregnancy [see Use in Specific Populations].


Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations].

Missed Dose

Instruct patients that if they miss a dose of RETROVIR, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see DOSAGE AND ADMINISTRATION].

Last reviewed on RxList: 3/10/2017
This monograph has been modified to include the generic and brand name in many instances.

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