Note: This document contains side effect information about elvitegravir. Some dosage forms listed on this page may not apply to the brand name Vitekta.
Applies to elvitegravir: oral tablet.
Serious side effects of Vitekta
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take this drug. Tell your doctor right away if you have any new signs after you start this drug, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
Other side effects of Vitekta
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Diarrhea.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to elvitegravir: oral tablet.
Gastrointestinal
Very common (10% or more): Increased lipase (14%), diarrhea (up to 13%)
Common (1% to 10%): Abdominal pain, vomiting, nausea, increased serum amylase
Uncommon (0.1% to 1%): Dyspepsia, abdominal distension, flatulence[Ref]
Increased serum amylase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in 6% of patients.
If serum amylase was greater than 1.5 x ULN, lipase was also measured. Increased lipase (grades 3 to 4) has been reported in 14% of patients.[Ref]
Hepatic
Increased total bilirubin (greater than 2.5 x ULN), GGT (greater than 5 x ULN), ALT (greater than 5 x ULN), and AST (greater than 5 x ULN) have been reported in 6%, 3%, 2%, and 2% of patients, respectively.[Ref]
Common (1% to 10%): Increased total bilirubin, increased ALT, increased AST[Ref]
Musculoskeletal
Common (1% to 10%): Increased creatine kinase, back pain, arthralgia, pain in extremity
Frequency not reported: Osteonecrosis[Ref]
Increased creatine kinase (at least 10 x ULN) has been reported in 6% of patients.[Ref]
Genitourinary
Hematuria (greater than 75 RBC/high power field) and urine glucose (4+) have been reported in 6% and 4% of patients, respectively.[Ref]
Common (1% to 10%): Hematuria, urine glucose[Ref]
Metabolic
Increased total cholesterol (greater than 300 mg/dL), increased total triglycerides (greater than 750 mg/dL), and hyperglycemia (greater than 250 mg/dL) have each been reported in 5% of patients.[Ref]
Common (1% to 10%): Increased total cholesterol, increased total triglycerides, hyperglycemia[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, paresthesia, somnolence, dysgeusia[Ref]
Hematologic
Decreased neutrophils (less than 750/mm3) has been reported in 3% of patients.[Ref]
Common (1% to 10%): Decreased neutrophils[Ref]
Psychiatric
Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt, insomnia[Ref]
Suicidal ideation and suicide attempt were reported in patients with history of depression or psychiatric illness.[Ref]
Dermatologic
Common (1% to 10%): Rash[Ref]
Other
Common (1% to 10%): Fatigue[Ref]
Immunologic
Frequency not reported: Autoimmune disorders (e.g., Graves' disease)[Ref]
