Darunavir Side Effects

Brand Names: Prezista

Please note - some side effects for Darunavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Darunavir - for the Consumer

Darunavir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Darunavir:

Diarrhea; headache; mild stomach pain; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; eye pain, inflammation, or redness; fever; loss of appetite; mouth sores; muscle or joint pain; pale stools; red, swollen, blistered, or peeling skin; severe headache or dizziness; severe or persistent nausea, vomiting, or stomach or back pain; unusual drowsiness, tiredness, or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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, fat redistribution, hyponatremia, polydipsia, decreased weight, and lipodystrophy have also been reported. Redistribution of body fat has been reported during postmarketing experience.

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 has 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%).

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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