Prezcobix Side Effects

Generic name: cobicistat / darunavir

Medically reviewed by Drugs.com. Last updated on Jun 21, 2024.

Note: This document provides detailed information about Prezcobix Side Effects associated with cobicistat / darunavir. Some dosage forms listed on this page may not apply specifically to the brand name Prezcobix.

Applies to cobicistat / darunavir: oral tablet, tablet oral.

Serious side effects of Prezcobix

Along with its needed effects, cobicistat / 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 cobicistat / darunavir:

Other side effects of Prezcobix

Some side effects of cobicistat / 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:

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine, to make sure it is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine should not be used together with alfuzosin (Uroxatral®), carbamazepine (Tegretol®), cisapride (Propulsid®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Mevacor®), lurasidone (Latuda®), naloxegol (Movantik®, Moventig®), oral midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Zocor®), St. John's wort, triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.

Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you 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.

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis) can occur with this medicine. Check with your doctor right away if you have any of the following symptoms: severe rash, blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may increase your risk for kidney problems, including acute kidney failure or Fanconi syndrome (when used together with tenofovir DF). Check with your doctor right away if you have changes in how much you urinate, decreased mental sharpness, nausea, vomiting, loss of appetite, or muscle twitches or cramps.

This medicine may increase blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may cause you to have excess body fat. Tell your doctor if you 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.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you 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, Guillain-Barré syndrome, and autoimmune hepatitis) may also occur.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to cobicistat / darunavir: oral tablet.

General adverse events

In clinical trials, safety of this drug was evaluated in therapy-naive and therapy-experienced patients using the individual components with other antiretrovirals. Safety data was also provided from clinical trials and postmarketing experience of darunavir/ritonavir and cobicistat in combination with other antiretrovirals. In the pooled data of a trial using darunavir 800 mg plus cobicistat 150 mg once a day with other antiretrovirals and an arm of a trial using this drug once a day with other antiretrovirals, the most common side effects were diarrhea, nausea, rash, and headache; serious side effects were diabetes mellitus, drug hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting. In clinical trials and postmarketing experience with darunavir 600 mg plus ritonavir 100 mg twice a day, the most common side effects were diarrhea, nausea, rash, headache, and vomiting; the most common serious side effects were acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhea, hepatitis, and pyrexia.

The manufacturer product information for cobicistat and darunavir should be consulted.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 23%), nausea (up to 17%)
• Common (1% to 10%): Increased pancreatic amylase, increased lipase, vomiting, abdominal pain, abdominal distension, flatulence, dyspepsia
• Uncommon (0.1% to 1%): Acute pancreatitis, increased pancreatic enzymes

Darunavir/ritonavir:

• Common (1% to 10%): Abdominal pain, diarrhea, nausea, vomiting, increased pancreatic amylase, increased pancreatic lipase, increased pancreatic enzyme
• Uncommon (0.1% to 1%): Acute pancreatitis, dyspepsia, flatulence
• Frequency not reported: Abdominal distension
• Postmarketing reports: Pancreatitis, relapsing pancreatitis, rectal hemorrhage, gastritis, esophageal candidiasis^[Ref]

Increased pancreatic amylase (grade 2: 6.5%; grade 3: 2.6%) and lipase (grade 2: 3.9%; grade 3: 1%; grade 4: 1.3%) were reported.^[Ref]

Dermatologic

• Very common (10% or more): Rash (included allergic dermatitis, drug eruption, erythema, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, pruritic rash, papular rash, skin reaction, papular urticaria; up to 15.7%)
• Common (1% to 10%): Pruritus
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome, angioedema, urticaria

Darunavir:

• Postmarketing reports: Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms (DRESS)

Darunavir/ritonavir:

• Common (1% to 10%): Pruritus, rash
• Uncommon (0.1% to 1%): Lipodystrophy (lipohypertrophy, lipodystrophy, lipoatrophy), Stevens-Johnson syndrome, severe skin reactions (sometimes with fever and/or transaminase elevations)
• Rare (less than 0.1%): DRESS
• Postmarketing reports: Swelling face, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, urticaria, angioedema^[Ref]

In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rashes were generally mild-to-moderate, often occurring within the first 4 weeks of therapy and resolving with continued use. The pooled data of a trial using darunavir 800 mg plus cobicistat 150 mg once a day with other antiretrovirals and an arm of a trial using this drug once a day with other antiretrovirals, therapy was discontinued due to rash in 1.9% of patients.^[Ref]

Other

• Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 10.9%), increased total cholesterol (up to 10.6%)
• Common (1% to 10%): Fatigue, asthenia, increased triglycerides
• Uncommon (0.1% to 1%): Increased alkaline phosphatase

Darunavir/ritonavir:

• Very common (10% or more): Increased total cholesterol (up to 22.9%), increased LDL cholesterol (up to 14.1%)
• Common (1% to 10%): Increased alkaline phosphatase, increased triglycerides
• Uncommon (0.1% to 1%): Asthenia, fatigue
• Postmarketing reports: Increased blood alkaline phosphatase, clostridial infection, cryptosporidiosis infection, sepsis, drug toxicity

Antiretroviral therapy:

• Frequency not reported: Increased weight, increased blood lipids^[Ref]

Increased LDL cholesterol (grade 2: 10.9%; grade 3: 4.8%), total cholesterol (grade 2: 10.6%; grade 3: 1%), triglycerides (grade 2: 1.4%; grade 3: 1.4%), and alkaline phosphatase (grade 2: 1%) were reported.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 10%)

Darunavir/ritonavir:

• Common (1% to 10%): Headache
• Postmarketing reports: Cytomegalovirus encephalitis, progressive multifocal leukoencephalopathy, altered state of consciousness, cerebrovascular accident, dizziness, facial palsy, grand mal convulsion, ischemic cerebral infarction, nervous system disorder, neuromyopathy, petit mal epilepsy^[Ref]

Metabolic

• Common (1% to 10%): Increased glucose, anorexia, hypercholesterolemia, hypertriglyceridemia
• Uncommon (0.1% to 1%): Diabetes mellitus, dyslipidemia, hyperglycemia, hyperlipidemia

Darunavir:

• Postmarketing reports: Redistribution of body fat

Darunavir/ritonavir:

• Very common (10% or more): Increased glucose (up to 10.8%)
• Common (1% to 10%): Anorexia
• Uncommon (0.1% to 1%): Diabetes mellitus
• Frequency not reported: Hypercholesterolemia, hyperglycemia, hypertriglyceridemia
• Postmarketing reports: Dehydration, hyperkalemia, metabolic acidosis, 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]

Increased glucose (grade 2: 6.5%) was reported.^[Ref]

Hepatic

• Common (1% to 10%): Increased AST, increased ALT, increased hepatic enzyme

Darunavir/ritonavir:

• Common (1% to 10%): Increased ALT, increased AST
• Uncommon (0.1% to 1%): Drug-induced hepatitis, hepatitis, cytolytic hepatitis, acute hepatitis
• Frequency not reported: Hyperbilirubinemia, hepatic transaminase elevations
• Postmarketing reports: Bile duct obstruction, hepatic cirrhosis, hepatic failure, hepatotoxicity, jaundice, hepatitis B, increased blood bilirubin, abnormal liver function test, liver injury (including fatalities)^[Ref]

Increased AST (grade 2: 6.1%; grade 3: 2.3%; grade 4: 0.6%) and ALT (grade 2: 3.2%; grade 3: 1.9%; grade 4: 1%) were reported.

In patients using darunavir/ritonavir, hepatic transaminase elevations were reported more often in those coinfected with HIV and hepatitis B and/or C virus than in patients infected with HIV only.^[Ref]

Renal

• Common (1% to 10%): Increased creatinine

Cobicistat:

• Frequency not reported: Decreased estimated CrCl, increased serum creatinine, renal tubular secretion of creatinine inhibited (actual renal glomerular function not affected), decreased estimated glomerular filtration rate (based on CrCl), renal impairment (including acute renal failure, Fanconi syndrome)

Darunavir/ritonavir:

• Postmarketing reports: Acute renal failure, renal tubular necrosis, decreased creatinine renal clearance, decreased glomerular filtration rate, renal failure^[Ref]

Increased creatinine (grade 2) was reported in 3.2% of patients.

Within 7 days after starting cobicistat 150 mg in a phase I trial, estimated glomerular filtration rate (eGFR) change from baseline averaged -9.9 mL/min in patients with normal renal function (eGFR at least 80 mL/min [calculated by Cockcroft-Gault method]) and -11.9 mL/min in patients with mild to moderate renal dysfunction (eGFR 50 to 79 mL/min [calculated by Cockcroft-Gault method]). These eGFR decreases were reversible after cobicistat was discontinued and did not affect the actual glomerular filtration rate.

In a phase III trial using darunavir 800 mg plus cobicistat 150 mg once a day with other antiretrovirals, eGFR (calculated by Cockcroft-Gault method) change from baseline averaged -9.6 mL/min at week 2, -11.5 mL/min at week 24, and -9.6 mL/min at week 48. In an arm of a phase III trial using this drug once a day with other antiretrovirals, eGFR (calculated by Cockcroft-Gault method) change from baseline averaged -11.1 mL/min at week 48; eGFR (based on cystatin C) change from baseline averaged +2.9 mL/min/1.73 m2 at week 48.

Renal impairment (including acute renal failure and Fanconi syndrome) has been reported when cobicistat was used in a regimen containing tenofovir.^[Ref]

Hypersensitivity

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

Darunavir/ritonavir:

• Postmarketing reports: Drug hypersensitivity^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia

Darunavir:

• Postmarketing reports: Rhabdomyolysis (associated with coadministration with HMG-CoA reductase inhibitors)

Darunavir/ritonavir:

• Uncommon (0.1% to 1%): Myalgia, osteonecrosis
• Postmarketing reports: Myositis, rhabdomyolysis, sensation of heaviness, arthritis, bone pain, pain in extremities, arthropathy

HIV protease inhibitors:

• Rare (0.01% to 0.1%): Rhabdomyolysis
• Frequency not reported: Increased creatine phosphokinase (CPK), myalgia, myositis^[Ref]

Increased CPK, myalgia, myositis, and rarely, rhabdomyolysis have been reported with HIV protease inhibitors, especially when coadministered with nucleoside reverse transcriptase inhibitors.

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.^[Ref]

Psychiatric

• Common (1% to 10%): Abnormal dreams

Darunavir/ritonavir:

• Uncommon (0.1% to 1%): Abnormal dreams
• Postmarketing reports: Completed suicide, anxiety, depression^[Ref]

Immunologic

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

Darunavir/ritonavir:

• Uncommon (0.1% to 1%): Immune reconstitution 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%): Gynecomastia^[Ref]

Cardiovascular

Darunavir/ritonavir:

• Postmarketing reports: Bradycardia, myocarditis^[Ref]

Hematologic

Darunavir/ritonavir:

• Postmarketing reports: Anemia, pancytopenia, thrombocytopenia, neutropenia

HIV protease inhibitors:

• Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs^[Ref]

Respiratory

Darunavir/ritonavir:

• Postmarketing reports: Acute respiratory distress syndrome, pharyngeal lesion, pneumothorax, respiratory failure, pulmonary edema, epistaxis^[Ref]

Genitourinary

Darunavir/ritonavir:

• Postmarketing reports: Hematuria, proteinuria^[Ref]

Oncologic

Darunavir/ritonavir:

• Postmarketing reports: Diffuse large B-cell neoplasm, malignant hepatic neoplasm, lymphoma^[Ref]

Ocular

Darunavir/ritonavir:

• Postmarketing reports: Eye swelling, uveitis, maculopathy, blurred vision^[Ref]

See also:

Frequently asked questions

• What drugs are contained in the HIV treatment Symtuza?

Further information

Prezcobix 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