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
  • 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 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
  • 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

General

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.

Hepatic

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.

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

Metabolic

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")

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.

Psychiatric

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

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.

Nervous system

Very common (10% or more): Headache, dizziness
Common (1% to 10%): Somnolence

Gastrointestinal

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

Renal

Common (1% to 10%): Increased creatinine
Frequency not reported: Membranous glomerulonephritis, mesangioproliferative glomerulonephritis, nephrolithiasis
Postmarketing reports: Nephrotic syndrome

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.

Dermatologic

Common (1% to 10%): Rash
Frequency not reported: Lipodystrophy

Other

Common (1% to 10%): Fatigue

Hematologic

Common (1% to 10%): Decreased white blood cell count, decreased hemoglobin, decreased platelet count

Immunologic

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)

Endocrine

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 (the active ingredient contained in Edurant) group, and of -0.6 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 side effects, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency.

Frequency not reported: Decreased basal cortisol, decreased adrenocorticotropic hormone (ACTH)-stimulated cortisol levels, adrenal insufficiency

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