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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
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 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

General

Most side effects reported during therapy with darunavir (the active ingredient contained in Prezista) 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.

Gastrointestinal

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.

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

Metabolic

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

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.

Hepatic

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 (the active ingredient contained in Prezista) 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.

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

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

Psychiatric

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

Other

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

Dermatologic

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

Cardiovascular

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

Hematologic

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

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.

Renal

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

Musculoskeletal

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

Respiratory

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

Hypersensitivity

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

Genitourinary

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

Immunologic

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)

Endocrine

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

Ocular

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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