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Darunavir Side Effects

Not all side effects for darunavir 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 darunavir: oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by darunavir. 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 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
  • 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 of the side effects that can occur with darunavir 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
  • 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 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 therapy discontinuation in 2.3% and 4.7% of therapy-naive and therapy-experienced subjects, respectively, in randomized trials.[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.[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[Ref]


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, hyperlactatemia, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis, redistribution of body fat[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.[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.

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]

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[Ref]

Nervous system

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]


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]


Common (1% to 10%): Asthenia, fatigue
Uncommon (0.1% to 1%): Pyrexia, chest pain, peripheral edema, herpes simplex, flushing, malaise, feeling hot, pain
Rare (less than 0.1%): Chills, abnormal feeling, xerosis
Frequency not reported: Rigors, hyperthermia[Ref]


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
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[Ref]


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]


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, spontaneous bleeding[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%): Acute renal failure, renal failure, nephrolithiasis, elevated blood creatinine
Rare (less than 0.1%): Decreased creatinine renal clearance
Frequency not reported: Renal insufficiency[Ref]


Uncommon (0.1% to 1%): Myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremities, osteoporosis, elevated blood creatine phosphokinase
Rare (less than 0.1%): Musculoskeletal stiffness, arthritis, joint stiffness
Frequency not reported: Osteopenia, myositis
Postmarketing reports: Rhabdomyolysis[Ref]


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]


Uncommon (0.1% to 1%): Drug hypersensitivity
Frequency not reported: Facial edema[Ref]


Uncommon (0.1% to 1%): Proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria, erectile dysfunction, gynecomastia
Frequency not reported: Polyuria[Ref]


Uncommon (0.1% to 1%): Immune reconstitution syndrome
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]


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


Uncommon (0.1% to 1%): Conjunctival hyperemia, dry eye
Rare (less than 0.1%): Visual disturbance[Ref]


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