Darunavir Side Effects

Some side effects of darunavir 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 darunavir: oral suspension, oral tablet

Along with its needed effects, darunavir 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 darunavir:

Less common
  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • skin rash
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
Rare
  • Abdominal or stomach pain or tenderness
  • acid or sour stomach
  • belching
  • blistering, peeling, or loosening of the skin
  • bloating
  • chills
  • clay colored stools
  • constipation
  • cough
  • dark urine
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • dizziness
  • excess air or gas in the stomach or intestines
  • fast heartbeat
  • fever
  • full feeling
  • headache
  • heartburn
  • indigestion
  • itching
  • joint or muscle pain
  • lack or loss of strength
  • light-colored stools
  • loss of appetite
  • muscle aching or cramping
  • nausea and vomiting
  • passing gas
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the feet or lower legs
  • swollen joints
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin
Incidence not known
  • Muscle pain or stiffness
  • swelling or puffiness of the face

Some side effects of darunavir 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:

More common
  • Stuffy or runny nose
Less common
  • Gaining weight around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to darunavir: oral suspension, oral tablet

General

The majority of side effects reported during treatment with darunavir plus ritonavir were mild in severity. The most common side effects of at least moderate intensity were diarrhea, nausea, vomiting, headache, rash, and abdominal pain. Adverse events led to discontinuation of darunavir in 2.3% and 4.7% of treatment-naive and treatment-experienced subjects, respectively, in randomized trials.

Gastrointestinal

Gastrointestinal side effects of at least moderate intensity have included diarrhea (up to 14%), nausea (up to 7%), vomiting (up to 5%), abdominal pain (up to 6%), anorexia (2%), abdominal distension (2%), dyspepsia (up to 2%), acute pancreatitis (less than 2%), and flatulence (less than 2%). Dry mouth and constipation have been reported.

Hepatic

Hepatic side effects of at least moderate intensity have included acute hepatitis (e.g., acute hepatitis, cytolytic hepatitis, hepatotoxicity; less than 2%) and increased hepatic enzyme. Hyperbilirubinemia (Grade 2: less than 1%; Grade 3: less than 1%; Grade 4: less than 1%), hypoalbuminemia, and elevated aspartate aminotransferase (Grade 2: up to 7%; Grade 3: up to 4%; Grade 4: up to 1%), alanine aminotransferase (Grade 2: up to 9%; Grade 3: up to 3%; Grade 4: up to 1%), alkaline phosphatase (Grade 2: up to 1%; Grade 3: less than 1%), and gamma glutamyl transferase have been reported. In patients receiving darunavir/ritonavir, the incidence of adverse events and clinical chemistry abnormalities was not higher in those coinfected with hepatitis B or C virus compared with patients who were not coinfected, with the exception of increased hepatic enzymes.

Hematologic

Hematologic side effects have included decreased white blood cell count, lymphocytes, total absolute neutrophil count, and platelets; increased partial thromboplastin time and plasma prothrombin time; and anemia. Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.

Metabolic

Metabolic side effects of at least moderate intensity have included diabetes mellitus (up to 2%), hypercholesterolemia, hyperglycemia, hypertriglyceridemia, increased low density lipoprotein, and increased pancreatic enzyme. Elevated pancreatic lipase (Grade 2: 3%; Grade 3: up to 2%; Grade 4: less than 1%), pancreatic amylase (Grade 2: up to 6%; Grade 3: up to 7%), glucose levels (Grade 2: up to 11%; Grade 3: up to 1%; Grade 4: less than 1%), total cholesterol (Grade 2: up to 25%; Grade 3: up to 10%), triglycerides (Grade 2: up to 10%; Grade 3: up to 7%; Grade 4: up to 3%), and low-density lipoprotein cholesterol (Grade 2: 14%; Grade 3: up to 9%) have been reported. Hypoglycemia, hyperuricemia, decreased bicarbonate, hypocalcemia, hyponatremia, hypernatremia, hyperlipidemia, decreased appetite, obesity, hyponatremia, polydipsia, decreased weight, and lipodystrophy have also been reported. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Redistribution of body fat has been reported during postmarketing experience. New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, and ketoacidosis have been reported during postmarketing experience in patients receiving protease inhibitors.

Nervous system

Nervous system side effects of at least moderate intensity have included headache (up to 7%). Peripheral neuropathy, hypoesthesia, paresthesia, somnolence, transient ischemic attack, insomnia, dizziness, and progressive multifocal leukoencephalopathy have been reported.

Psychiatric

Psychiatric side effects of at least moderate intensity have included abnormal dreams (less than 2%). Memory impairment, confusion state, disorientation, irritability, altered mood, nightmare, and anxiety have been reported.

Musculoskeletal

Musculoskeletal side effects of at least moderate intensity have included myalgia and osteonecrosis in less than 2% of patients. Arthralgia, pain in extremities, osteopenia, and osteoporosis have been reported. Rarely, rhabdomyolysis has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included myocardial infarction, tachycardia, and hypertension.

Other

Other side effects of at least moderate intensity have included asthenia (up to 3%) and fatigue (up to 2%). Vertigo, pyrexia, rigors, hyperthermia, peripheral edema, and herpes simplex infection have been reported.

Renal

Renal side effects have included acute renal failure, renal insufficiency, nephrolithiasis, and polyuria.

Respiratory

Respiratory side effects have included nasopharyngitis, dyspnea, cough, hiccups, pneumonia, and upper respiratory tract infection.

Dermatologic

Dermatologic side effects of at least moderate intensity have included rash (up to 7%), and angioedema, pruritus, urticaria, and Stevens-Johnson syndrome in less than 2% of patients. Folliculitis, lipoatrophy, night sweats, allergic dermatitis, eczema, toxic skin eruption, alopecia, dermatitis medicamentosa, hyperhidrosis, skin inflammation, maculopapular rash, and erythema multiforme have been reported. Severe skin reactions (in some cases accompanied by fever and/or elevations of transaminases) have been reported during clinical development programs. Rarely, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported during postmarketing experience.

Endocrine

Endocrine side effects have included gynecomastia.

Genitourinary

Genitourinary side effects have included acute renal failure, renal insufficiency, nephrolithiasis, polyuria, and gynecomastia.

Immunologic

Immunologic side effects of at least moderate intensity have included immune reconstitution syndrome (less than 2%). Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Hypersensitivity

Hypersensitivity side effects of at least moderate intensity have included drug hypersensitivity (less than 2%). Facial edema has been reported.

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