Darunavir Side Effects

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Applies to darunavir: oral suspension, oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Altocor®, Altoprev®, Mevacor®), lurasidone (Latuda®), naloxegol (Movantik®, Moventig®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Methergine®, Migranal®, Wigraine®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.

Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragm, contraceptive foam, or jelly. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase blood sugar levels. Check with your doctor right away if you or your child have increased thirst or increased urination. If you notice a change in the results of your or your child's blood or urine sugar tests, or if you have any questions, check with your doctor.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

This medicine may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.

Common side effects of darunavir

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:

Serious side effects of darunavir

Along with its needed effects, darunavir 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:

For healthcare professionals

Applies to darunavir: oral suspension, oral tablet.

General adverse events

The most common side effects reported with darunavir/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/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/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

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]

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

Metabolic

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]

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/ritonavir.^[Ref]

Nervous system

Darunavir/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/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/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/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/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/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/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/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/cobicistat:

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

Darunavir/ritonavir:

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

Genitourinary

Darunavir/ritonavir:

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

Immunologic

Darunavir/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/ritonavir:

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

Ocular

Darunavir/ritonavir:

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

See also:

Frequently asked questions

• What drugs are contained in the HIV treatment Symtuza?

Further information

Darunavir side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer