Note: This document contains side effect information about darunavir. Some dosage forms listed on this page may not apply to the brand name Prezista.

Summary

Common side effects of Prezista include: skin rash. Other side effects include: nausea. Continue reading for a comprehensive list of adverse effects.

Applies to darunavir: oral suspension, oral tablet.

Serious side effects of Prezista

Along with its needed effects, darunavir (the active ingredient contained in Prezista) 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

• Blistering, peeling, or loosening of the skin
• blurred vision
• chills
• cough
• diarrhea
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red irritated eyes
• red skin lesions, often with a purple center
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness

Rare

• Belching
• black, tarry stools
• bloating
• constipation
• dark urine
• decreased appetite
• difficulty with moving
• dizziness
• excess air or gas in the stomach or bowels
• fast heartbeat
• feeling of fullness
• fever
• headache
• heartburn
• indigestion
• lack or loss of strength
• light-colored stools
• loss of appetite
• muscle aching or cramping
• nausea
• painful or difficult urination
• passing gas
• stomach pain or tenderness
• swelling of the feet or lower legs
• swollen glands
• swollen joints
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Lower back pain
• muscle pain, spasms, or stiffness
• pain or burning while urinating
• sudden decrease in amount of urine
• swelling or puffiness of the face

Other side effects of Prezista

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 most common side effects reported with darunavir (the active ingredient contained in Prezista) cobicistat were diarrhea, nausea, and rash. The manufacturer product information for cobicistat or cobicistat-darunavir should be consulted.

Most side effects reported during therapy with darunavir/ritonavir were mild in severity. The most common side effects were diarrhea, nausea, vomiting, headache, rash, and abdominal pain. Adverse events led to therapy discontinuation in 2.3% and 4.7% of therapy-naive and therapy-experienced subjects, respectively, in randomized trials. The manufacturer product information for ritonavir should be consulted for ritonavir-associated side effects.^[Ref]

Gastrointestinal

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Very common (10% or more): Diarrhea (28%), nausea (23%)

-Common (1% to 10%): Vomiting, abdominal pain, abdominal distension, dyspepsia, flatulence, increased pancreatic enzymes

-Uncommon (0.1% to 1%): Acute pancreatitis

Darunavir/ritonavir:

-Very common (10% or more): Diarrhea (up to 14.4%)

-Common (1% to 10%): Nausea, vomiting, abdominal pain, elevated pancreatic amylase, elevated pancreatic lipase, abdominal distension, dyspepsia, flatulence, elevated blood amylase

-Uncommon (0.1% to 1%): Pancreatitis, acute pancreatitis, gastritis, gastroesophageal reflux disease, aphthous stomatitis, retching, dry mouth, abdominal discomfort, constipation, elevated lipase, eructation, oral dysesthesia

-Rare (less than 0.1%): Stomatitis, hematemesis, cheilitis, dry lip, coated tongue

-Frequency not reported: Elevated pancreatic enzyme^[Ref]

Elevated pancreatic amylase (grade 2: up to 7.4%; grade 3: up to 7.8%; grade 4: up to 1.1%) and pancreatic lipase (grade 2: 5.2%; grade 3: up to 2.6%; grade 4: less than 1%) have been reported with darunavir/ritonavir.^[Ref]

Other

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Fatigue

-Uncommon (0.1% to 1%): Asthenia

Darunavir/ritonavir:

-Very common (10% or more): Elevated total cholesterol (up to 25%), elevated glucose levels (up to 15.4%), elevated low-density lipoprotein (LDL) cholesterol (up to 14.4%), elevated triglycerides (up to 10.4%)

-Common (1% to 10%): Asthenia, fatigue

-Uncommon (0.1% to 1%): Pyrexia, chest pain, peripheral edema, flushing, malaise, feeling hot, pain, decreased weight, increased weight, decreased high density lipoprotein, elevated blood alkaline phosphatase, elevated lactate dehydrogenase

-Rare (less than 0.1%): Chills, abnormal feeling, xerosis

-Frequency not reported: Rigors, hyperthermia, facial edema, decreased bicarbonate

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipids^[Ref]

Elevated total cholesterol (grade 2: up to 25%; grade 3: up to 10%), LDL cholesterol (grade 2: 14.4%; grade 3: up to 9.1%), triglycerides (grade 2: up to 10.4%; grade 3: up to 8.2%; grade 4: up to 3.9%), and alkaline phosphatase (grade 2: up to 3.9%; grade 3: less than 1%) have been reported with darunavir/ritonavir.^[Ref]

Dermatologic

In clinical trials, rashes were generally mild-to-moderate, often occurring within the first 4 weeks of therapy and resolving with continued use.^[Ref]

Darunavir/cobicistat:

-Very common (10% or more): Rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalized rash, allergic dermatitis; 16%)

-Common (1% to 10%): Angioedema, pruritus, urticaria

Darunavir/ritonavir:

-Common (1% to 10%): Rash (including macular, maculopapular, papular, erythematous, pruritic rash), pruritus, lipodystrophy (including lipohypertrophy, lipodystrophy, lipoatrophy)

-Uncommon (0.1% to 1%): Angioedema, generalized rash, urticaria, night sweats, allergic dermatitis, eczema, erythema, alopecia, hyperhidrosis, Stevens-Johnson syndrome, acne, dry skin, nail pigmentation, herpes simplex, severe skin reactions (in some cases accompanied by fever and/or elevations of transaminases)

-Rare (less than 0.1%): Drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, dermatitis, seborrheic dermatitis, skin lesion, xeroderma

-Frequency not reported: Folliculitis, lipoatrophy, toxic skin eruption, dermatitis medicamentosa, skin inflammation

-Postmarketing reports: Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS^[Ref]

Metabolic

Elevated glucose levels (grade 2: up to 15.4%; grade 3: up to 1.7%; grade 4: less than 1%) has been reported with darunavir (the active ingredient contained in Prezista) ritonavir.^[Ref]

Darunavir/cobicistat:

-Common (1% to 10%): Anorexia, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, hyperlipidemia

Darunavir/ritonavir:

-Very common (10% or more): Elevated glucose levels (up to 15.4%)

-Common (1% to 10%): Hyperlipidemia, anorexia, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia

-Uncommon (0.1% to 1%): Gout, decreased appetite, polydipsia, hyperglycemia, insulin resistance, increased appetite

-Frequency not reported: Hypoglycemia, hyperuricemia, hypocalcemia, hyponatremia, hypernatremia, obesity, hypoalbuminemia

-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis, redistribution of body fat

HIV protease inhibitors:

-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes, hyperglycemia, diabetic ketoacidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), metabolic abnormalities (such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)^[Ref]

Nervous system

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Very common (10% or more): Headache

Darunavir/ritonavir:

-Common (1% to 10%): Headache, peripheral neuropathy, dizziness

-Uncommon (0.1% to 1%): Lethargy, hypoesthesia, paresthesia, dysgeusia, disturbance in attention, memory impairment, somnolence, vertigo

-Rare (less than 0.1%): Syncope, convulsion, ageusia, sleep phase rhythm disturbance

-Frequency not reported: Transient ischemic attack, progressive multifocal leukoencephalopathy^[Ref]

Hepatic

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Increased hepatic enzyme

Darunavir/ritonavir:

-Common (1% to 10%): Elevated ALT, elevated AST

-Uncommon (0.1% to 1%): Hepatitis, acute hepatitis, cytolytic hepatitis, hepatic steatosis, hepatotoxicity, elevated transaminase, elevated blood bilirubin/hyperbilirubinemia, elevated GGT

-Frequency not reported: Elevated hepatic enzymes

-Postmarketing reports: Liver injury (including fatalities)^[Ref]

Hyperbilirubinemia (grade 2: less than 1%; grade 3: less than 1%; grade 4: less than 1%), and elevated ALT (grade 2: up to 9%; grade 3: up to 3%; grade 4: up to 1%), and AST (grade 2: up to 7%; grade 3: up to 4.1%; grade 4: up to 1.2%) have been reported with darunavir/ritonavir.

In patients receiving darunavir/ritonavir, the incidence of side effects 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 elevated hepatic enzymes.^[Ref]

Psychiatric

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Abnormal dreams

Darunavir/ritonavir:

-Common (1% to 10%): Insomnia

-Uncommon (0.1% to 1%): Depression, disorientation, sleep disorder, abnormal dreams, nightmare, anxiety, decreased libido, irritability

-Rare (less than 0.1%): Confusion state, altered mood, restlessness^[Ref]

Cardiovascular

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Myocardial infarction, angina pectoris, prolonged ECG QT, tachycardia, hypertension

-Rare (less than 0.1%): Acute myocardial infarction, sinus bradycardia, palpitations^[Ref]

Hematologic

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Thrombocytopenia, neutropenia, anemia, leukopenia

-Rare (less than 0.1%): Elevated eosinophil count

-Frequency not reported: Decreased white blood cell count, decreased lymphocytes, decreased total absolute neutrophil count, decreased platelets, increased partial thromboplastin time, increased plasma prothrombin time

HIV protease inhibitors:

-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs^[Ref]

Renal

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Increased blood creatinine

Darunavir/ritonavir:

-Uncommon (0.1% to 1%): Acute renal failure, renal failure, nephrolithiasis, elevated blood creatinine

-Rare (less than 0.1%): Decreased creatinine renal clearance

-Frequency not reported: Renal insufficiency^[Ref]

Musculoskeletal

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Myalgia

Darunavir/ritonavir:

-Uncommon (0.1% to 1%): Myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremities, osteoporosis, elevated blood creatine phosphokinase (CPK)

-Rare (less than 0.1%): Musculoskeletal stiffness, arthritis, joint stiffness

-Frequency not reported: Osteopenia

-Postmarketing reports: Rhabdomyolysis

HIV protease inhibitors:

-Frequency not reported: Increased CPK, myalgia, myositis, rhabdomyolysis^[Ref]

Osteonecrosis has been reported, particularly with commonly known risk factors (e.g., corticosteroid use, alcohol use, severe immunosuppression, higher body mass index), advanced HIV disease, or long-term combination antiretroviral therapy.

Increased CPK, myalgia, myositis, and rarely, rhabdomyolysis have been reported with HIV protease inhibitors, especially when coadministered with nucleoside reverse transcriptase inhibitors.^[Ref]

Respiratory

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Dyspnea, cough, epistaxis, throat irritation

-Rare (less than 0.1%): Rhinorrhea

-Frequency not reported: Nasopharyngitis, hiccups, pneumonia, upper respiratory tract infection^[Ref]

Hypersensitivity

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Common (1% to 10%): Drug hypersensitivity

Darunavir/ritonavir:

-Uncommon (0.1% to 1%): Drug hypersensitivity^[Ref]

Genitourinary

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria, erectile dysfunction

-Frequency not reported: Polyuria^[Ref]

Immunologic

Darunavir (the active ingredient contained in Prezista) cobicistat:

-Uncommon (0.1% to 1%): Immune reconstitution inflammatory syndrome

Darunavir/ritonavir:

-Uncommon (0.1% to 1%): Immune reconstitution inflammatory syndrome

Combination antiretroviral therapy:

-Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)^[Ref]

Endocrine

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Hypothyroidism, elevated blood thyroid stimulating hormone, gynecomastia^[Ref]

Ocular

Darunavir (the active ingredient contained in Prezista) ritonavir:

-Uncommon (0.1% to 1%): Conjunctival hyperemia, dry eye

-Rare (less than 0.1%): Visual disturbance^[Ref]