Complera Side Effects

Generic Name: emtricitabine / rilpivirine / tenofovir

Note: This page contains information about the side effects of emtricitabine / rilpivirine / tenofovir. Some of the dosage forms included on this document may not apply to the brand name Complera.

Not all side effects for Complera 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 emtricitabine / rilpivirine / tenofovir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by emtricitabine / rilpivirine / tenofovir. 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 emtricitabine / rilpivirine / tenofovir:

More common
  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • thoughts of killing oneself
  • tiredness
  • trouble concentrating
  • trouble sleeping
Less common
  • Body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cough
  • difficulty with breathing
  • ear congestion
  • fever or chills
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • tightness in the chest
  • unsteadiness or awkwardness
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
Incidence not known
  • Abdominal or stomach discomfort
  • agitation
  • bloating
  • bloody or cloudy urine
  • bone pain
  • broken bones, especially the thigh bone
  • changes in behavior
  • confusion
  • constipation
  • dark urine
  • decreased appetite
  • decrease in the amount of urine
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • fast heartbeat
  • fast, shallow breathing
  • frequent urination
  • general tiredness and weakness
  • headache
  • hostility
  • increased thirst
  • indigestion
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • light-colored stools
  • muscle pain or cramps
  • muscle tenderness, wasting, or weakness
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • rapid weight gain
  • seizures
  • skin rash, hives, itching
  • sleepiness
  • swelling of the face, ankles, hands, feet, or lower legs
  • upper right stomach pain
  • vomiting
  • yellow eyes or skin

Some of the side effects that can occur with emtricitabine / rilpivirine / tenofovir 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:

More common
  • Abnormal dreams
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • difficulty with moving
  • heartburn
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • stomach discomfort or upset
Incidence not known
  • Lack or loss of strength

For Healthcare Professionals

Applies to emtricitabine / rilpivirine / tenofovir: oral tablet

General

During clinical studies, 550 patients received rilpivirine in combination with emtricitabine plus tenofovir. Treatment was discontinued due to side effects, regardless of severity, in 2% of patients taking rilpivirine in combination with emtricitabine plus tenofovir. The most common side effects leading to discontinuation were psychiatric disorders.

Psychiatric

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: 2%), insomnia (at least moderate intensity: 2%), abnormal dreams (at least moderate intensity: 1%)

Emtricitabine and/or tenofovir:
Very common (10% or more): Depression, insomnia, abnormal dreams
Common (1% to 10%): Anxiety

Rilpivirine:
Common (1% to 10%): Depressive disorders (regardless of causality, severity; 8%), anxiety (at least moderate intensity; less than 2%)

Depression, insomnia, and abnormal dreams have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir. Anxiety has been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

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

Hepatic

Very common (10% or more): Increased ALT (Grade 1: 19%), 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: 6%; Grade 2: 3%; Grade 3: 1%)

Emtricitabine or tenofovir:
Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine:
Frequency not reported: Liver failure, liver decompensation

Rilpivirine:
Common (1% to 10%): 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: Hepatic enzyme elevation, hepatotoxicity

Tenofovir:
Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
Postmarketing reports: Hepatic steatosis, hepatitis, elevated liver enzymes (primarily AST, ALT, and gamma glutamyltransferase)

Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 after discontinuation of emtricitabine or tenofovir and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.

The incidence of hepatic enzyme elevation was higher in patients receiving rilpivirine who were coinfected with hepatitis B or C than in patients without coinfection.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs, including tenofovir, in combination with other antiretroviral agents.

Metabolic

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Very common (10% or more): Increased fasted total cholesterol (Grade 1: 14%), increased fasted LDL cholesterol (Grade 1: 13%)
Common (1% to 10%): Increased fasted total cholesterol (Grade 2: 6%; Grade 3: less than 1%), increased fasted LDL cholesterol (Grade 2: 5%; Grade 3: 1%), increased fasted triglycerides (Grade 2: 1%; Grade 3: 1%)

Emtricitabine or tenofovir:
Frequency not reported: Increased alkaline phosphatase (greater than 550 units/L), increased or decreased serum glucose (less than 40 or greater than 250 mg/dL)

Rilpivirine:
Very common (10% or more): Decreased appetite (at least moderate intensity: less than 2%)

Tenofovir:
Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia

Nervous system

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

Emtricitabine and/or tenofovir:
Very common (10% or more): Headache, dizziness
Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis, neuropathy)

Rilpivirine:
Very common (10% or more): Somnolence (at least moderate intensity: less than 2%), sleep disorders (at least moderate intensity: less than 2%)

Headache and dizziness have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir. Paresthesia and peripheral neuropathy (including peripheral neuritis and neuropathy) have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

Renal

Common (1% to 10%): Increased creatinine (Grade 1: 6%; Grade 2: 1%; Grade 3: less than 1%)

Rilpivirine:
Common (1% to 10%): 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%)
Frequency not reported: Increased serum creatinine
Postmarketing reports: Nephrotic syndrome

Tenofovir:
Frequency not reported: New onset or worsening renal impairment
Postmarketing reports: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, interstitial nephritis (including acute cases)

During Phase 3 trials, an increase in serum creatinine was seen over 96 weeks of therapy with rilpivirine. 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.

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Gastrointestinal

Diarrhea and nausea have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir. Abdominal pain, dyspepsia, and vomiting have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

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

Emtricitabine and/or tenofovir:
Very common (10% or more): Diarrhea, nausea
Common (1% to 10%): Abdominal pain, dyspepsia, vomiting
Frequency not reported: Increased pancreatic amylase (greater than 2 times upper limit of normal [ULN]), increased serum amylase (greater than 175 units/L), increased lipase (greater than 3 times ULN)

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

Tenofovir:
Postmarketing reports: Pancreatitis, increased amylase, abdominal pain

Dermatologic

Rash has been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir.

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

Emtricitabine and tenofovir:
Very common (10% or more): Rash

Emtricitabine:
Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)

Tenofovir:
Postmarketing reports: Rash

Musculoskeletal

Arthralgia, back pain, and myalgia have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur due to proximal renal tubulopathy.

Emtricitabine or tenofovir:
Common (1% to 10%): Arthralgia, back pain, myalgia
Frequency not reported: Increased creatine kinase (males: greater than 990 units/L; females: greater than 845 units/L)

Tenofovir:
Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Other

Other side effects have included fatigue in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir. Fever and pain have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

Emtricitabine and/or tenofovir:
Very common (10% or more): Fatigue
Common (1% to 10%): Fever, pain

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

Tenofovir:
Frequency not reported: Higher 1,25 vitamin D levels
Postmarketing reports: Asthenia

Respiratory

Emtricitabine or tenofovir:
Common (1% to 10%): Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, rhinitis

Tenofovir:
Postmarketing reports: Dyspnea

Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, and rhinitis have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir.

Hematologic

Emtricitabine or tenofovir:
Frequency not reported: Decreased neutrophils (less than 750/mm3)

Genitourinary

Emtricitabine or tenofovir:
Frequency not reported: Increased glycosuria (3+ or greater), increased hematuria (greater than 75 red blood cells/high power field)

Tenofovir:
Postmarketing reports: Proteinuria, polyuria

Hypersensitivity

Tenofovir:
Postmarketing reports: Allergic reaction (including angioedema)

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 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.

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

Tenofovir:
Frequency not reported: Higher serum parathyroid hormone levels

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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