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.
More frequent side effects include: attempted suicide, suicidal ideation, depressed mood, depression, dysphoria, major depressive disorder, and mood changes. See below for a comprehensive list of adverse effects.
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
- feeling sad or empty
- gaseous abdominal or stomach pain
- lack of appetite
- loss of interest or pleasure
- recurrent fever
- severe nausea or vomiting
- swelling of the face, feet, or lower legs
- thoughts of killing oneself
- trouble concentrating
- trouble sleeping
- 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
- fear or nervousness
- sleepiness or unusual drowsiness
- unusual tiredness or weakness
- 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
Most side effects occurred in the first 48 weeks of therapy. The most common side effects (at least moderate severity) were depression, headache, insomnia, increased transaminases, and rash. This drug was discontinued due to side effects in 2% of patients.[Ref]
Increased ALT (grade 1: 18%; grade 2: 5%; grade 3: 1%; grade 4: 1%), AST (grade 1: 16%; grade 2: 4%; grade 3: 2%; grade 4: 1%), and total bilirubin (grade 1: 5%; grade 2: 3%; grade 3: 1%) have been reported.
The incidence of hepatic enzyme elevation was greater in patients coinfected with hepatitis B and/or C virus compared with uninfected patients.[Ref]
Very common (10% or more): Increased ALT (up to 18%), increased AST (up to 16%), increased transaminases
Common (1% to 10%): Increased total bilirubin
Frequency not reported: Hepatotoxicity, cholecystitis, cholelithiasis, drug-induced acute allergic hepatitis[Ref]
Common (1% to 10%): Rash
Frequency not reported: Lipodystrophy
Postmarketing reports: Severe skin and hypersensitivity reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS])[Ref]
During phase 3 trials, 3% of patients using this drug reported at least grade 2 therapy-related rashes; most rashes were grade 1 or 2 and developed in the first 4 to 6 weeks of therapy.[Ref]
Very common (10% or more): Increased fasted total cholesterol (up to 17%), increased fasted low-density lipoprotein (LDL) cholesterol (up to 14%)
Common (1% to 10%): Increased fasted triglycerides, decreased appetite
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[Ref]
Increased fasted total cholesterol (grade 1: 17%; grade 2: 7%; grade 3: less than 1%), fasted LDL cholesterol (grade 1: 14%; grade 2: 5%; grade 3: 1%), and fasted triglycerides (grade 2: 2%; grade 3: 1%) have been reported.[Ref]
Very common (10% or more): Insomnia
Common (1% to 10%): Depression, depressed mood, depressive disorders (reported as depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation), abnormal dreams, sleep disorders
Frequency not reported: Anxiety[Ref]
Psychiatric disorders were the most common side effects leading to treatment discontinuation. In the phase 3 clinical trials, ten patients (1%), discontinued this drug due to psychiatric disorders.
During phase 3 trials through 96 weeks, depressive disorders (regardless of causality, severity) were reported in 9% of patients.[Ref]
Very common (10% or more): Headache, dizziness
Common (1% to 10%): Somnolence[Ref]
Very common (10% or more): Nausea, increased pancreatic amylase
Common (1% to 10%): Abdominal pain, vomiting, abdominal discomfort, increased lipase, dry mouth
Frequency not reported: Diarrhea[Ref]
Postmarketing reports: Severe skin and hypersensitivity reactions (including DRESS)
Common (1% to 10%): Increased creatinine
Frequency not reported: Membranous glomerulonephritis, mesangioproliferative glomerulonephritis, nephrolithiasis
Postmarketing reports: Nephrotic syndrome[Ref]
Grade 1, 2, and 3 increases in creatinine have been reported in 6%, 1%, and less than 1% of patients, respectively.
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 therapy, with a mean change of 0.1 mg/dL (range: -0.3 to 0.6 mg/dL) observed after 96 weeks of therapy. In subjects with mild or moderate baseline renal dysfunction, the serum creatinine increase observed was similar to that seen in subjects with normal renal function. These changes were not considered clinically relevant and no subject discontinued therapy due to increases in serum creatinine.[Ref]
Common (1% to 10%): Fatigue[Ref]
Common (1% to 10%): Decreased white blood cell count, decreased hemoglobin, decreased platelet count[Ref]
Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]
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 (-0.69 mcg/dL) in the rilpivirine (the active ingredient contained in Edurant) group, and of -0.6 nmol/L (-0.02 mcg/dL) 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.
In the rilpivirine group, 43 of 588 patients with normal 250 mcg ACTH stimulation test at baseline developed abnormal 250 mcg ACTH stimulation test (peak cortisol level less than 18.1 mcg/dL) during the trial versus 18 of 561 patients in the efavirenz group. Abnormal 250 mcg ACTH stimulation test at week 96 was seen in 14 of the 43 rilpivirine patients and 9 of the 18 efavirenz patients. Clinical significance of abnormal 250 mcg ACTH stimulation tests (or the higher rate in the rilpivirine group) has not been established.
Overall, there were no serious side effects, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency.[Ref]
Frequency not reported: Decreased basal cortisol, decreased adrenocorticotropic hormone (ACTH)-stimulated cortisol levels, adrenal insufficiency, abnormal 250 mcg ACTH stimulation test[Ref]
1. "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals, Titusville, NJ.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Ahmed Y, Siddiqui W, Enoch CB, Albrecht H, Bookstaver PB "Rare case of rilpivirine-induced severe allergic hepatitis." J Antimicrob Chemother (2012):
4. Cohen CJ, Molina JM, Cassetti I, et al. "Week 96 efficacy and safety of rilpivirine in treatment-naive, HIV-1 patients in two Phase III randomised trials." AIDS 27 (2013): 930-50
5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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.
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