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

Along with its needed effects, rilpivirine (the active ingredient contained in Edurant) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rilpivirine:

Less common
  • Abdominal or stomach fullness
  • changes in behavior
  • cloudy or bloody urine
  • discouragement
  • feeling sad or empty
  • gaseous abdominal or stomach pain
  • high blood pressure
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • recurrent fever
  • severe nausea or vomiting
  • sleeplessness
  • swelling of the face, feet, or lower legs
  • thoughts of killing oneself
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • yellow eyes or skin

Some side effects of rilpivirine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach discomfort
  • abnormal dreams
  • decreased appetite
  • diarrhea
  • dizziness
  • fear or nervousness
  • headache
  • nausea
  • rash
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Decreased amount of fat from your legs, arms, or face
  • increased amount of fat in the upper back and neck, or around the chest and stomach area

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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