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Elvitegravir Side Effects

For the Consumer

Applies to elvitegravir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by elvitegravir. In the event that any of these side effects do occur, they may require medical attention.

Minor Side Effects

Some of the side effects that can occur with elvitegravir 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:

More common:
  • Diarrhea
Less common:
  • Headache
  • nausea
Less common or rare:
  • Discouragement
  • feeling sad or empty
  • heartburn
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • rash
  • stomach discomfort, upset, or pain
  • thoughts or attempts at killing oneself
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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

Increased creatine kinase (at least 10 x ULN) has been reported in 6% of patients.[Ref]

Common (1% to 10%): Increased creatine kinase, back pain, arthralgia, pain in extremity
Frequency not reported: Osteonecrosis[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

Common (1% to 10%): Decreased neutrophils[Ref]

Decreased neutrophils (less than 750/mm3) has been reported in 3% of patients.[Ref]

Psychiatric

Suicidal ideation and suicide attempt were reported in patients with history of depression or psychiatric illness.[Ref]

Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt, insomnia[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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Vitekta (elvitegravir)." Gilead Sciences, Foster City, CA.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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