Enfuvirtide Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 22, 2025.

Applies to enfuvirtide: subcutaneous powder for solution.

Precautions

It is very important that your doctor check you your child's progress at regular visits, especially during the first few weeks that you use this medicine. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase the risk of having pneumonia. This is more likely to occur if you smoke or have a history of lung disease. Check with your doctor right away if you have chest pain or tightness, cough, fever, chills, or troubled breathing.

This medicine can cause reactions at the injection site. Almost all people get injection site reactions with enfuvirtide. These reactions hurt and itch, and they are usually mild to moderate but can occasionally be severe. These reactions generally happen within the first week of treatment and as you keep using enfuvirtide. If the injection site nodules drain pus or cause redness that spreads or streaks from the sites, or you are worried about the reaction you are having, call your doctor right away.

Some people who have used Biojector® 2000 to inject this medicine have had shooting nerve pain and tingling lasting up to 6 months when injected close to large nerves or near joints, or had bleeding, bruising, or lumps. Talk to your doctor if you have concerns about this.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of enfuvirtide

Along with its needed effects, enfuvirtide 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 enfuvirtide:

Other side effects of enfuvirtide

Some side effects of enfuvirtide 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:

For healthcare professionals

Applies to enfuvirtide: subcutaneous kit, subcutaneous powder for injection.

General adverse events

In general, the most common side effects in patients receiving enfuvirtide and a background regimen have included injection site reactions, diarrhea, nausea, and fatigue.^[Ref]

Local

Local side effects have been reported in 98% of patients and have included pain/discomfort at the injection site (96%), induration (90%), erythema (91%), nodules and cysts (80%), pruritus (65%), ecchymosis (52%), injection site infection (including abscess and cellulitis, 1.7%), minor local bleeding, injection site reactions, injection site mass, injection site inflammation, and injection site edema. The administration of enfuvirtide using the Biojector (R) 2000 needle-free device has been associated with hematomas, bruising, tenderness, and swelling. At least one case of localized amyloidosis at the site of enfuvirtide injection has been reported.^[Ref]

Gastrointestinal

Gastrointestinal side effects associated with enfuvirtide and a background regimen have included diarrhea (31.7%), nausea (22.8%), abdominal pain (3.9%), dry mouth (2.1%), pancreatitis (3.0%), abdominal distension, vomiting, flatulence, and oral candidiasis. Constipation, increased amylase, and increased lipase have also been reported; however, causality has not been determined.^[Ref]

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions in less than 1% of patients and in some cases have recurred upon rechallenge. Signs and symptoms of reactions have included rash, fever, nausea, vomiting, chills, rigors, hypotension, elevated liver transaminases, primary immune complex reaction, respiratory distress, glomerulonephritis, and Guillain-Barre syndrome. Worsening of abacavir hypersensitivity reaction has been reported; however, causality has not been established. General allergic reaction (not defined as hypersensitivity reaction) has also been reported.^[Ref]

Metabolic

Metabolic side effects associated with enfuvirtide in combination with a background regimen have included decreased weight (6.6%), decreased appetite (3.2%), anorexia (2.3%), and hyperlipemia. Increased triglycerides and hyperglycemia have also been reported; however, causality has not been established.^[Ref]

Nervous system

Nervous system side effects associated with enfuvirtide and a background regimen have included peripheral neuropathy, taste disturbance, sixth nerve palsy and fatal Guillain-Barre syndrome have also been reported; however, causality has not been established. Dizziness, headache, and epidural abscess have also been reported. The administration of enfuvirtide using the Biojector (R) 2000 needle-free device has been associated with neuralgia and/or paresthesia (nerve pain) lasting up to 6 months when injected at sites where large nerves run close to the skin.^[Ref]

Other

Other side effects associated with enfuvirtide and a background regimen have included fatigue (20.2%), herpes simplex (3.5%), influenza-like illness (2.4%), malaise, fever, and chills. Asthenia and sepsis have also been reported; however, causality has not been determined.^[Ref]

Psychiatric

Psychiatric side effects associated with enfuvirtide and a background regimen have included insomnia, depression, anxiety, and suicide attempt; however, causality has not been established. Abnormal thinking and agitation have also been reported.^[Ref]

Respiratory

Respiratory side effects associated with enfuvirtide and a background regimen have included cough (3.9%), sinusitis (6.0%), bronchitis, nasopharyngitis, and upper respiratory tract infection. Pneumonia (2.7%), including fatalities, pneumopathy, and respiratory distress have also been reported; however, causality has not been determined. Patients should be carefully monitored for symptoms of pneumonia.^[Ref]

Dermatologic

Dermatologic side effects associated with enfuvirtide and a background regimen have included folliculitis (2.4%), dermatitis, pruritus, dry skin, skin papilloma, skin discoloration, and rash (not defined as hypersensitivity reaction).^[Ref]

Musculoskeletal

Musculoskeletal side effects associated with enfuvirtide and a background regimen have included myalgia (2.7%), limb pain (2.9%), and increased creatine phosphokinase (Grade 3, 6.9%; Grade 4, 2.6%). Vertebral osteomyelitis has also been reported.^[Ref]

Ocular

Ocular side effects associated with enfuvirtide and a background regimen have included conjunctivitis (2.0%).^[Ref]

Hematologic

Hematologic side effects associated with enfuvirtide and a background regimen have included eosinophilia (1 to 2 times ULN, 9.1%; greater than 2 times ULN, 1.8%), leukopenia, and anemia. Thrombocytopenia, neutropenia, and lymphadenopathy have also been reported; however, causality has not been established.^[Ref]

Renal

Renal side effects have included glomerulonephritis, tubular necrosis, renal insufficiency, and renal failure (including fatalities); however, causality has not been established.^[Ref]

Hepatic

Hepatic side effects associated with enfuvirtide and a background regimen have included increased ALT (Grade 3, 4.1%; Grade 4, 1.2%). Increased AST, increased GGT, toxic hepatitis, and hepatic steatosis have also been reported; however, causality has not been determined.^[Ref]

Cardiovascular

Cardiovascular side effects associated with enfuvirtide and a background regimen have included unstable angina pectoris; however, causality has not been established.^[Ref]

Genitourinary

Genitourinary side effects have included hematuria.^[Ref]

Immunologic

Immunologic side effects have included immune reconstitution syndrome, opportunistic infections, and general infectious diseases. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.^[Ref]

See also:

Further information

Enfuvirtide 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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