Edurant Side Effects
Generic Name: rilpivirine
Note: This page contains information about the side effects of rilpivirine. Some of the dosage forms included on this document may not apply to the brand name Edurant.
Not all side effects for Edurant may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to rilpivirine: oral tablet
In addition to its needed effects, some unwanted effects may be caused by rilpivirine (the active ingredient contained in Edurant). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking rilpivirine:Less common
- Abdominal or stomach fullness
- changes in behavior
- cloudy or bloody urine
- feeling sad or empty
- gaseous abdominal or stomach pain
- high blood pressure
- 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
- unable to sleep
- yellow eyes or skin
Some of the side effects that can occur with rilpivirine 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: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
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%)
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
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%)
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
Common (1% to 10%): Rash (at least moderate intensity: 3%)
Common (1% to 10%): Headache (at least moderate intensity: 3%), somnolence (at least moderate intensity: less than 2%), dizziness (at least moderate intensity: 1%)
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%)
Common (1% to 10%): Fatigue (at least moderate intensity: 2%)
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.
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
More about Edurant (rilpivirine)
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