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Symtuza Side Effects

Generic name: cobicistat / darunavir / emtricitabine / tenofovir alafenamide

Medically reviewed by Drugs.com. Last updated on Jan 14, 2024.

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

Applies to cobicistat / darunavir / emtricitabine / tenofovir alafenamide: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Warning: Post treatment acute exacerbation of hepatitis BSevere acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide.

Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue darunavir/cobicistat/emtricitabine/tenofovir alafenamide.

If appropriate, anti-hepatitis B therapy may be warranted.

Serious side effects of Symtuza

Along with its needed effects, cobicistat/darunavir/emtricitabine/tenofovir alafenamide 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 / emtricitabine / tenofovir alafenamide:

More common side effects

  • rash

Less common side effects

  • blistering, peeling, or loosening of the skin
  • bloating
  • blurred vision
  • chills
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dry mouth
  • fast heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general tiredness and weakness
  • heavy jaw feeling
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • loosening of a tooth
  • loss of appetite
  • loss of consciousness
  • nausea
  • pain, swelling, or numbness in the mouth or jaw
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • 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
  • stomachache
  • sweating
  • trouble breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • yellow eyes or skin

Incidence not known

  • lower back pain
  • muscle cramps, spasms, or stiffness
  • pain or burning while urinating
  • sudden decrease in amount of urine

Other side effects of Symtuza

Some side effects of cobicistat / darunavir / emtricitabine / tenofovir alafenamide 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:

Less common side effects

  • abnormal dreams
  • belching
  • difficulty in moving
  • excess air or gas in the stomach or bowels
  • headache
  • heartburn
  • passing gas
  • redistribution or accumulation of body fat
  • stomach discomfort, upset, or pain
  • swelling of the breasts or breast soreness in both females and males
  • swollen joints
  • weight loss

For healthcare professionals

Applies to cobicistat / darunavir / emtricitabine / tenofovir alafenamide: oral tablet.

General adverse events

In clinical trials, the most common side effects reported in therapy-naive patients were diarrhea, headache, rash, nausea, fatigue, and abdominal pain; in suppressed therapy-experienced patients, diarrhea, headache, arthralgia, abdominal pain, fatigue, and rash were reported most often. This drug was discontinued due to side effects in 2% and up to 1% of therapy-naive and therapy-experienced patients, respectively.[Ref]

Gastrointestinal

Elevated amylase (1.5 to less than 3 times the upper limit of normal [1.5 to less than 3 x ULN]: up to 4.2%; 3 to less than 5 x ULN: 0.4%; at least 5 x ULN: up to 0.3%) and lipase (greater than 1.5 to less than 3 x ULN: 0.3%; 1.5 to less than 3 x ULN: 0.4%; 3 to less than 5 x ULN: up to 0.4%; at least 5 x ULN: up to 0.3%) have been reported.[Ref]

Other

Darunavir-containing regimen:

Antiretroviral therapy:

Elevated total cholesterol (240 to less than 300 mg/dL [6.19 to less than 7.77 mmol/L]: up to 21%; at least 300 mg/dL [at least 7.77 mmol/L]: up to 3.7%), LDL cholesterol (160 to 189 mg/dL [4.12 to less than 4.9 mmol/L]: up to 15.6%; at least 190 mg/dL [at least 4.9 mmol/L]: up to 6.3%), triglycerides (301 to 500 mg/dL [greater than 3.42 to 5.7 mmol/L]: up to 7%; 501 to 1000 mg/dL [greater than 5.7 to 11.4 mmol/L]: up to 1.4%; greater than 1000 mg/dL [greater than 11.4 mmol/L]: less than 1%), and alkaline phosphatase (2.5 to less than 5 x ULN: up to 0.3%) have been reported.[Ref]

Musculoskeletal

Darunavir-containing regimen:

HIV protease inhibitors:

In therapy-naive patients, BMD decreases of at least 5% at the lumbar spine were reported in 16% of patients using this drug and 22% of patients using cobicistat-darunavir plus emtricitabine-tenofovir disoproxil fumarate (DF); BMD decreases of at least 7% at the femoral neck were reported in 2% of patients using this drug and 15% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF. In boosted protease inhibitor and tenofovir DF-treated patients, BMD decreases of at least 5% at the lumbar spine were reported in 2% of patients using this drug and 9% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF; BMD decreases of at least 7% at the femoral neck were reported in no patients using this drug and 2% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF.[Ref]

Dermatologic

Darunavir-containing regimen:

Rash was commonly reported with darunavir; rashes were generally mild-to-moderate, often occurring within the first 4 weeks of therapy and resolving with continued use. In trials in therapy-naive patients, 12.7% of those using this drug reported rash (most were grade 1) and 1.5% of patients discontinued therapy due to rash (1 due to rash and hypersensitivity). In the trial in suppressed therapy-experienced patients, 5.1% of patients using this drug reported rash (most were grade 1) and no patients discontinued therapy due to rash.[Ref]

Nervous system

Metabolic

Darunavir-containing regimen:

Emtricitabine and tenofovir DF:

HIV protease inhibitors:

Antiretroviral therapy:

Elevated glucose levels/hyperglycemia (126 to 250 mg/dL [6.95 to less than 13.89 mmol/L]: up to 6.9%; 251 to 500 mg/dL [13.89 to less than 27.75 mmol/L]: up to 1%) have been reported.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

Renal

Cobicistat:

Tenofovir prodrugs:

Elevated creatinine (greater than 1.3 to 1.8 x ULN [or increased greater than 0.3 mg/dL above baseline]: up to 5.4%; greater than 1.8 to less than 3.5 x ULN [or increased 1.5 to less than 2 x above baseline]: up to 0.3%; at least 3.5 x ULN [or increased at least 2 x above baseline]: less than 1%) has been reported.

In a trial in therapy-naive HIV-1-infected patients (median estimated glomerular filtration rate [eGFR] 119 mL/min at baseline), mean serum creatinine increased by 0.05 mg/dL from baseline to week 48; median serum creatinine was 0.9 mg/dL at baseline at 0.95 mg/dL at week 48. Serum creatinine increased and eGFR (according to Cockcroft-Gault) decreased by week 2 of therapy and remained stable through 96 weeks; the median change in eGFR (according to Cockcroft-Gault) was -5.5 and -5.2 mL/min at 48 and 96 weeks, respectively. Median UPCR was 47 mg/g at baseline and 30 mg/g at week 48.

In a trial in virologically-suppressed patients treated with an HIV protease inhibitor and tenofovir DF-containing regimen (mean eGFR 104 mL/min at baseline) who switched to this drug or who remained on initial regimen (mean eGFR 103 mL/min at baseline), mean serum creatinine was similar to baseline for both at week 48; median UPCR was 62 mg/g at baseline and 37 mg/g at week 48 in those who switched to this drug and 63 mg/g at baseline and 53 mg/g at week 48 in those who remained on initial regimen.[Ref]

Hepatic

Darunavir-containing regimen:

Emtricitabine and/or tenofovir DF:

Elevated ALT (greater than 2.5 to less than 5 x ULN: up to 2.4%; 5 to less than 10 x ULN: up to 1.1%; at least 10 x ULN: up to 0.4%) and AST (greater than 2.5 to less than 5 x ULN: up to 1.6%; greater than 5 to less than 10 x ULN: up to 1.1%; at least 10 x ULN: up to 0.5%) have been reported.

Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients coinfected with HIV-1 and hepatitis B virus after discontinuation of products containing emtricitabine and/or tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

Hematologic

HIV protease inhibitors:

Psychiatric

Hypersensitivity

Immunologic

Darunavir-containing regimen:

Combination antiretroviral therapy:

Endocrine

Darunavir-containing regimen:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2018) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen Pharmaceuticals

Frequently asked questions

Further information

Symtuza 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.