Isentress Side Effects

Generic Name: raltegravir

Note: This page contains information about the side effects of raltegravir. Some of the dosage forms included on this document may not apply to the brand name Isentress.

Not all side effects for Isentress may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to raltegravir: oral powder for suspension, oral tablet, oral tablet chewable

In addition to its needed effects, some unwanted effects may be caused by raltegravir (the active ingredient contained in Isentress). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking raltegravir:

Less common or rare
  • Blood in the urine
  • burning or stinging of the skin
  • dark urine
  • decreased frequency or amount of urine
  • fast heartbeat
  • fever
  • general tiredness and weakness
  • hoarseness
  • increased thirst
  • irritation
  • joint pain, stiffness, or swelling
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea and vomiting
  • pain in the groin or genitals
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • rash, hives, or itching
  • redness of the skin
  • sharp back pain just below the ribs
  • swelling of the eyelids, face, lips, hands, lower legs, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weight gain
  • yellow eyes and skin
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • headache
  • muscle cramps or spasms
  • muscle pain or stiffness
  • pinpoint red spots on the skin
  • stomach pain, continuing
  • unusual bleeding or bruising

Some of the side effects that can occur with raltegravir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Dizziness
  • trouble sleeping
Less common or rare
  • Acid or sour stomach
  • belching
  • depression
  • heartburn
  • indigestion
  • lack or loss of strength
  • stomach discomfort, upset, or pain
  • tenderness in the stomach area
  • thoughts of killing oneself or changes in behavior
Incidence not known
  • Delusions of persecution, mistrust, suspiciousness, or combativeness
  • diarrhea
  • fear or nervousness

For Healthcare Professionals

Applies to raltegravir: oral granule for reconstitution, oral tablet, oral tablet chewable

General

The safety report of raltegravir (the active ingredient contained in Isentress) 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 effects of moderate to severe intensity which occurred in treatment-naive patients at a higher rate compared to efavirenz were insomnia, headache, nausea, dizziness, and fatigue. The most common side effect of moderate to severe intensity which occurred in treatment-experienced patients at a higher rate compared to placebo was headache. The rates of discontinuation due to side effects were 5% and 10% in treatment-naive subjects receiving raltegravir and efavirenz, respectively, and 4% and 5% in treatment-experienced subjects receiving raltegravir and placebo, respectively.

Hepatic

Common (1% to 10%): Elevated alanine transaminase (ALT; Grade 2: up to 11%, Grade 3: up to 4%, Grade 4: up to 2%), elevated aspartate transaminase (AST; Grade 2: up to 9%, Grade 3: up to 5%, Grade 4: 1%), elevated total bilirubin (Grade 2: up to 6%, Grade 3: up to 3%), hepatitis (less than 2%)
Uncommon (0.1% to 1%): Elevated total bilirubin (Grade 4: up to 1%)
Frequency not reported: AST and ALT abnormalities
Postmarketing reports: Hepatic failure (with and without associated hypersensitivity)

The rates of AST and ALT abnormalities were higher in patients with hepatitis B and/or hepatitis C virus coinfection. In treatment-naive patients, Grade 2 or higher laboratory abnormalities indicating a worsening Grade from baseline of AST, ALT, or total bilirubin occurred in 22%, 44%, and 17%, respectively, of coinfected patients treated with raltegravir as compared to 13%, 13%, and 5% of all other patients treated with raltegravir. In treatment-experienced patients, Grade 2 or higher laboratory abnormalities indicating a worsening Grade from baseline of AST, ALT, or total bilirubin occurred in 29%, 34%, and 13%, respectively, of coinfected patients treated with raltegravir as compared to 11%, 10%, and 9% of all other patients treated with raltegravir.

Hepatic failure (with and without associated hypersensitivity) has been reported during postmarketing experience in patients with underlying liver disease and/or concomitant medications.

Metabolic

Common (1% to 10%): Elevated serum glucose (Grade 2: up to 10%, Grade 3: up to 3%), elevated alkaline phosphatase (Grade 2: up to 2%)
Uncommon (0.1% to 1%): Elevated alkaline phosphatase (Grade 3: less than 1%, Grade 4: up to 1%)
Frequency not reported: Acquired lipodystrophy, elevated triglycerides, elevated fasting cholesterol, elevated low density lipoprotein cholesterol

Gastrointestinal

Common (1% to 10%): Elevated lipase (Grade 2: 5%, Grade 3: 2%), nausea (moderate to severe intensity: 3%), elevated pancreatic amylase (Grade 2: 2%, Grade 3: 4%), abdominal pain (less than 2%), gastritis (less than 2%), dyspepsia (less than 2%), vomiting (less than 2%)
Uncommon (0.1% to 1%): Elevated pancreatic amylase (Grade 4: less than 1%)
Rare (less than 0.1%): Mouth ulceration (at least 1 case), peritonitis (including perihepatitis; at least 1 case)
Postmarketing reports: Diarrhea

Nervous system

Common (1% to 10%): Headache (moderate to severe intensity: up to 4%), dizziness (moderate to severe intensity: 2%)
Postmarketing reports: Cerebellar ataxia

Psychiatric

Common (1% to 10%): Insomnia (moderate to severe intensity: 4%), depression (including suicidal ideation and behaviors; less than 2%)
Frequency not reported: Abnormal dreams, exacerbation of depression
Postmarketing reports: Anxiety, paranoia

Depression occurred particularly in patients with history of psychiatric illness.

Hematologic

Common (1% to 10%): Decreased absolute neutrophil count (Grade 2: up to 4%, Grade 3: 3%, Grade 4: 1%), decreased platelet count (Grade 2: up to 3%), decreased hemoglobin (Grade 2: 1%, Grade 3: 1%)
Uncommon (0.1% to 1%): Decreased platelet count (Grade 3: up to 1%, Grade 4: up to 1%), decreased hemoglobin (Grade 4: less than 1%)
Postmarketing reports: Thrombocytopenia

Other

Common (1% to 10%): Fatigue (moderate to severe intensity: 2%), asthenia (less than 2%), genital herpes (less than 2%), herpes zoster (less than 2%)
Frequency not reported: Pyrexia, diaphoresis

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase (Grade 2: 2%, Grade 3: 4%, Grade 4: 3%)
Frequency not reported: Myopathy, rhabdomyolysis
Postmarketing reports: Rhabdomyolysis

Cardiovascular

Frequency not reported: Myocardial infarction

Renal

Common (1% to 10%): Nephrolithiasis (less than 2%), renal failure (less than 2%)
Frequency not reported: Toxic nephropathy, chronic renal failure, renal tubular necrosis

Hypersensitivity

Common (1% to 10%): Hypersensitivity (less than 2%)
Frequency not reported: Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure)

Dermatologic

Frequency not reported: Skin rash; pruritus; severe, potentially life-threatening, and fatal skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis)

Rashes considered drug related were mild to moderate in severity and did not limit treatment.

Oncologic

Frequency not reported: Kaposi's sarcoma, lymphoma, squamous cell carcinoma, skin cancer, hepatocellular carcinoma, rectal adenocarcinoma, anal cancer

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

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

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