Edurant Side Effects

Generic name: rilpivirine

Note: This document contains side effect information about rilpivirine. Some of the dosage forms listed on this page may not apply to the brand name Edurant.

Some side effects of Edurant may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rilpivirine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rilpivirine (the active ingredient contained in Edurant) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• mood changes, anxiety, severe depression, feeling hopeless, thoughts about suicide or hurting yourself;

• fever, chills, cough with yellow or green mucus;

• stabbing chest pain, wheezing, feeling short of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe pain in your upper stomach spreading to your shoulder or back, stomach bloating, vomiting, sweating, fever, chills.

Common side effects may include:

• sleep problems (insomnia), unusual dreams;

• mild nausea, vomiting, stomach pain, diarrhea;

• headache, dizziness;

• mild skin rash;

• tired feeling; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rilpivirine: oral tablet

Psychiatric

Psychiatric disorders were the most common adverse drug reactions leading to treatment discontinuation. In the Phase 3 clinical trials, ten patients (1%), discontinued rilpivirine (the active ingredient contained in Edurant) therapy due to psychiatric disorders.

During Phase 3 trials through 96 weeks, depressive disorders (regardless of causality, severity) were reported in 9% of patients.

Common (1% to 10%): Depressive disorders (reported as depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation; at least moderate intensity: 5%), insomnia (at least moderate intensity: 3%), abnormal dreams (at least moderate intensity: 2%), sleep disorders (at least moderate intensity: less than 2%), anxiety (at least moderate intensity: less than 2%)

Hepatic

Very common (10% or more): Increased ALT (Grade 1: 18%), increased AST (Grade 1: 16%)
Common (1% to 10%): Increased ALT (Grade 2: 5%; Grade 3: 1%; Grade 4: 1%), increased AST (Grade 2: 4%; Grade 3: 2%; Grade 4: 1%), increased total bilirubin (Grade 1: 5%; Grade 2: 3%; Grade 3: 1%), cholecystitis (at least moderate intensity: less than 2%), cholelithiasis (at least moderate intensity: less than 2%)
Rare (less than 0.1%): Drug-induced acute allergic hepatitis (at least 1 case)
Frequency not reported: Hepatotoxicity

Metabolic

Very common (10% or more): Increased fasted total cholesterol (Grade 1: 17%), increased fasted LDL cholesterol (Grade 1: 14%)
Common (1% to 10%): Increased fasted total cholesterol (Grade 2: 7%), increased fasted LDL cholesterol (Grade 2: 5%; Grade 3: 1%), increased fasted triglycerides (Grade 2: 2%; Grade 3: 1%), decreased appetite (at least moderate intensity: less than 2%)
Uncommon (0.1% to 1%): Increased fasted total cholesterol (Grade 3: less than 1%)

Renal

During Phase 3 trials, an increase in serum creatinine was seen over 96 weeks of therapy. Most of this increase occurred within the first 4 weeks of treatment, with a mean change of 0.1 mg/dL (range: -0.3 mg/dL to 0.6 mg/dL) observed after 96 weeks of treatment. In subjects with mild or moderate baseline renal impairment, the serum creatinine increase observed was similar to that seen in subjects with normal renal function. These changes were not considered to be clinically relevant and no subject discontinued treatment due to increases in serum creatinine.

Common (1% to 10%): Increased creatinine (Grade 1: 6%; Grade 2: 1%), membranous glomerulonephritis (at least moderate intensity: less than 2%), mesangioproliferative glomerulonephritis (at least moderate intensity: less than 2%), nephrolithiasis (at least moderate intensity: less than 2%)
Uncommon (0.1% to 1%): Increased creatinine (Grade 3: less than 1%)
Postmarketing reports: Nephrotic syndrome

Dermatologic

Common (1% to 10%): Rash (at least moderate intensity: 3%)

Nervous system

Common (1% to 10%): Headache (at least moderate intensity: 3%), somnolence (at least moderate intensity: less than 2%), dizziness (at least moderate intensity: 1%)

Gastrointestinal

Common (1% to 10%): Abdominal pain (at least moderate intensity: 2%), nausea (at least moderate intensity: 1%), vomiting (at least moderate intensity: 1%), abdominal discomfort (at least moderate intensity: less than 2%), diarrhea (at least moderate intensity: less than 2%)

Other

Common (1% to 10%): Fatigue (at least moderate intensity: 2%)

Endocrine

Frequency not reported: Decreased basal cortisol, decreased ACTH-stimulated cortisol levels, adrenal insufficiency

In the pooled Phase 3 trials, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 nmol/L in the rilpivirine group, and of +0.1 nmol/L in the efavirenz group. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine group (+18.4 nmol/L) than in the efavirenz group (+54.1 nmol/L). Mean values for both basal and ACTH-stimulated cortisol values at Week 96 were within the normal range. Overall, there were no serious adverse events, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency.

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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