Isentress Side Effects

Generic Name: raltegravir

Please note - some side effects for Isentress may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Isentress - for the Consumer

Isentress

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Isentress:

Diarrhea; headache; nausea; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fainting; fever, chills, or sore throat; mental or mood changes (eg, anxiety, paranoia, depression); muscle pain, tenderness, or weakness; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or stomach pain; severe or persistent tiredness or weakness; shortness of breath; sudden, severe headache or vomiting; sudden vision changes; suicidal thoughts or actions; unusual lumps, skin growths, or skin changes; yellowing of the skin or eyes.

Isentress Side Effects - for the Professional

Isentress

• The most common adverse reactions of moderate to severe intensity (≥2%) which occurred at a higher exposure adjusted rate compared to placebo are headache, nausea, asthenia and fatigue (6.1).
• Creatine kinase elevations were observed in subjects who received Isentress. Myopathy and rhabdomyolysis have been reported; however, the relationship of Isentress to these events is not known. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions (6.1).

Side Effects by Body System

General

The safety report of raltegravir is based on 281 treatment-naive and 462 treatment-experienced HIV-infected patients receiving the indicated twice daily dosing regimen in combination with emtricitabine plus tenofovir and optimized background therapy, respectively. The most common side effect of moderate to severe intensity which occurred in treatment-naive patients at a higher rate compared to efavirenz was insomnia. The most common side effects of moderate to severe intensity which occurred in treatment-experienced patients at a higher exposure adjusted rate compared to placebo were nausea, headache, asthenia, and fatigue. The rates of discontinuation due to side effects were 3% and 6% in treatment-naive subjects receiving raltegravir and efavirenz, respectively, and 2% and 3% in treatment-experienced subjects receiving raltegravir and placebo, respectively.

Gastrointestinal

Gastrointestinal side effects of moderate to severe intensity have included nausea (greater than or equal to 2%). Abdominal pain (less than 2%), gastritis (less than 2%), diarrhea, and vomiting have been reported. At least one case of mouth ulceration has been reported.

Nervous system

Nervous system side effects of moderate to severe intensity have included insomnia (4%) and headache (greater than or equal to 2%). Dizziness has been reported in less than 2% of patients.

Metabolic

Metabolic side effects have included acquired lipodystrophy and elevated serum glucose (Grade 2: up to 8%, Grade 3: up to 2%), alkaline phosphatase (Grade 2: up to 2%, Grade 3: less than 1%, Grade 4: up to 1%), pancreatic amylase (Grade 2: 2%, Grade 3: 3%, Grade 4: less than 1%), and lipase (Grade 2: 4%, Grade 3: 1%). Elevated triglycerides, fasting cholesterol, and low density lipoprotein cholesterol have been reported.

Hepatic

Hepatic side effects have included hepatitis (less than 2%) and elevated aspartate transaminase (AST; Grade 2: up to 8%, Grade 3: up to 3%, Grade 4: less than 1%), alanine transaminase (ALT; Grade 2: up to 7%, Grade 3: up to 3%, Grade 4: up to 1%), and total bilirubin (Grade 2: up to 5%, Grade 3: up to 2%, Grade 4: up to 1%).

Hematologic

Hematologic side effects have included anemia (Grade 2: up to 1%, Grade 3: up to 1%, Grade 4: less than 1%), neutropenia (Grade 2: 3%, Grade 3: 3%, Grade 4: up to 1%), and thrombocytopenia (Grade 2: up to 3%, Grade 3: up to 1%, Grade 4: up to 1%).

Other

Other side effects of moderate to severe intensity have included asthenia and fatigue in greater than or equal to 2% of patients. Pyrexia and diaphoresis have been reported.

Musculoskeletal

Musculoskeletal side effects have included myopathy and rhabdomyolysis; however, relationship of raltegravir to these events is unknown. Elevated creatine kinase (Grade 2: 2%, Grade 3: 3%, Grade 4: 2%) has been reported.

Cardiovascular

Cardiovascular side effects have included myocardial infarction.

Renal

Renal side effects have included renal failure (less than 2%), toxic nephropathy, chronic renal failure, and renal tubular necrosis.

Hypersensitivity

Hypersensitivity side effects have included serious hypersensitivity reactions.

Oncologic

Oncologic side effects have included Kaposi's sarcoma, lymphoma, squamous cell carcinoma, skin cancer, hepatocellular carcinoma, rectal adenocarcinoma, and anal cancer, regardless of causality. The types and rates of specified cancers were expected in a highly immunodeficient population and most patients had other risk factors for cancer, including tobacco use, papillomavirus, and active hepatitis B virus infection. It is unknown if these cancer diagnoses were related to raltegravir use.

Immunologic

Immunologic side effects have included hypersensitivity (less than 2%), genital herpes, and herpes zoster.

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