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
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 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

General

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]

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.[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]

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[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]

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/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]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[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]

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[Ref]

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[Ref]

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[Ref]

Hypersensitivity

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

Genitourinary

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

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)[Ref]

Endocrine

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

Ocular

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

References

1. HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. National Institutes of Health "Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf." ([2014 Feb 12]):

2. Fenton C, Perry CM "Darunavir: In the Treatment of HIV-1 Infection." Drugs 67 (2007): 2791-801

3. Rittweger M, Arasteh K "Clinical pharmacokinetics of darunavir." Clin Pharmacokinet 46 (2007): 739-56

4. Taiwo BO, Hicks CB "Darunavir: an overview of an HIV protease inhibitor developed to overcome drug resistance." AIDS Read 17 (2007): 151-6, 159-61

5. McCoy C "Darunavir: a nonpeptidic antiretroviral protease inhibitor." Clin Ther 29 (2007): 1559-1576

6. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

7. Hoffman CJ, Gallant JE "When and how to use tipranavir and darunavir." AIDS Read 17 (2007): 194-8, 201

8. Warnke D, Barreto J, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

9. "Product Information. Prezista (darunavir)." Ortho Biotech Inc, Bridgewater, NJ.

10. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

11. Katlama C, Esposito R, Gatell JM, et al. "Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1." AIDS 21 (2007): 395-402

12. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." ([2013 Feb 12]):

13. Sekar V, Kestens D, Spinosa-Guzman S, et al. "The Effect of Different Meal Types on the Pharmacokinetics of Darunavir (TMC114)/Ritonavir in HIV-Negative Healthy Volunteers." J Clin Pharmacol 47 (2007): 479-84

14. Clotet B, Bellos N, Molina JM, et al. "Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials." Lancet 369 (2007): 1169-78

15. Hammer SM, Saag MS, Schechter M, et al. "Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel." JAMA 296 (2006): 827-43

16. Busse KH, Penzak SR "Darunavir: A second-generation protease inhibitor." Am J Health Syst Pharm 64 (2007): 1593-602

17. Holodniy M "Darunavir in the Treatment of HIV-1 Infection: A Viewpoint by Mark Holodniy." Drugs 67 (2007): 2802-3

18. "Darunavir (Prezista) for HIV infection." Med Lett Drugs Ther 48 (2006): 74-5

19. Poveda E, Blanco F, Garcia-Gasco P, Alcolea A, Briz V, Soriano V "Successful rescue therapy with darunabir (TMC114) in HIV-infected patients who have failed several ritonavir-boosted protease inhibitors." AIDS 20 (2006): 1558-60

20. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother 62 (2008): 879-88

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