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Prezista Side Effects

Generic Name: darunavir

Note: This page contains side effects data for the generic drug darunavir. It is possible that some of the dosage forms included below may not apply to the brand name Prezista.

It is possible that some side effects of Prezista may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to darunavir: oral suspension, oral tablet

As well as its needed effects, darunavir (the active ingredient contained in Prezista) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking darunavir, check with your doctor immediately:

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
  • 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 darunavir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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


Most side effects reported during therapy with darunavir (the active ingredient contained in Prezista) 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 most common side effects reported with darunavir/cobicistat were diarrhea, nausea, and rash. The manufacturer product information for cobicistat should be consulted.[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 (the active ingredient contained in Prezista) ritonavir.[Ref]

-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

-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[Ref]


Darunavir (the active ingredient contained in Prezista) ritonavir:
-Very common (10% or more): Elevated total cholesterol (up to 25%), elevated glucose levels (up to 15.4%), elevated low-density lipoprotein cholesterol (up to 14.4%), elevated triglycerides (up to 10.4%)
-Common (1% to 10%): Hyperlipidemia, anorexia, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia
-Uncommon (0.1% to 1%): Gout, decreased appetite, polydipsia, decreased weight, increased weight, hyperglycemia, insulin resistance, decreased high density lipoprotein, increased appetite, elevated LDH
-Frequency not reported: Hypoglycemia, hyperuricemia, decreased bicarbonate, hypocalcemia, hyponatremia, hypernatremia, obesity, hypoalbuminemia
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis, redistribution of body fat

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

Combination antiretroviral therapy:
-Frequency not reported: 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)

HIV protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes, hyperglycemia, diabetic ketoacidosis[Ref]

Elevated total cholesterol (Grade 2: up to 25%; Grade 3: up to 10%), glucose levels (Grade 2: up to 15.4%; Grade 3: up to 1.7%; Grade 4: less than 1%), low-density lipoprotein cholesterol (Grade 2: 14.4%; Grade 3: up to 9.1%), and triglycerides (Grade 2: up to 10.4%; Grade 3: up to 8.2%; Grade 4: up to 3.9%) have been reported with darunavir/ritonavir.[Ref]


Darunavir (the active ingredient contained in Prezista) 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
-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, severe skin reactions (in some cases accompanied by fever and/or elevations of transaminases)
-Postmarketing reports: Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS

-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[Ref]

Nervous system

Darunavir (the active ingredient contained in Prezista) 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

-Very common (10% or more): Headache[Ref]


Darunavir (the active ingredient contained in Prezista) 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 blood alkaline phosphatase, elevated GGT
-Frequency not reported: Elevated hepatic enzyme

-Common (1% to 10%): Increased hepatic enzyme[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%), AST (Grade 2: up to 7%; Grade 3: up to 4.1%; Grade 4: up to 1.2%), and alkaline phosphatase (Grade 2: up to 3.9%; Grade 3: less than 1%) 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]


Darunavir (the active ingredient contained in Prezista) 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

-Common (1% to 10%): Abnormal dreams[Ref]


Darunavir (the active ingredient contained in Prezista) ritonavir:
-Common (1% to 10%): Asthenia, fatigue
-Uncommon (0.1% to 1%): Pyrexia, chest pain, peripheral edema, flushing, malaise, feeling hot, pain
-Rare (less than 0.1%): Chills, abnormal feeling, xerosis
-Frequency not reported: Rigors, hyperthermia

-Common (1% to 10%): Fatigue
-Uncommon (0.1% to 1%): Asthenia[Ref]


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]


Spontaneous bleeding in patients with hemophilia A and B has been associated with protease inhibitors. 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.[Ref]

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


Darunavir (the active ingredient contained in Prezista) 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

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

-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

-Common (1% to 10%): Myalgia

HIV protease inhibitor therapy:
-Frequency not reported: Increased CPK, myalgia, myositis, rhabdomyolysis[Ref]


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]


Darunavir (the active ingredient contained in Prezista) ritonavir:
-Uncommon (0.1% to 1%): Drug hypersensitivity
-Frequency not reported: Facial edema

-Common (1% to 10%): Drug hypersensitivity[Ref]


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]


Darunavir (the active ingredient contained in Prezista) ritonavir:
-Uncommon (0.1% to 1%): Immune reconstitution syndrome

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

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


Darunavir (the active ingredient contained in Prezista) ritonavir:
-Uncommon (0.1% to 1%): Hypothyroidism, elevated blood thyroid stimulating hormone, gynecomastia[Ref]


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]


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