Understanding common side effects

The chart below outlines the most common side effects people may have when taking EPCLUSA and tips that may help manage them.

Most common side effects of EPCLUSA

Headache

  • tips:
  • Drink water. Limit coffee, tea, and soda with caffeine.
  • Try to rest and relax.

Tiredness

  • tips:
  • Do your hardest chores when you have the most energy.
  • Take short naps—20 minutes or less, and not close to bedtime.

When EPCLUSA is used with ribavirin for those with advanced cirrhosis, common side effects also include anemia, nausea, insomnia, and diarrhea.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of EPCLUSA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get started with EPCLUSA

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

Important Safety Information

What is the most important information I should know about EPCLUSA?

EPCLUSA can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting EPCLUSA treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with EPCLUSA. This may cause serious liver problems including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking EPCLUSA.

What should I tell my healthcare provider before taking EPCLUSA?

  • Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection or liver problems other than hepatitis C infection; if you have severe kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if EPCLUSA will harm your unborn baby or pass into your breast milk. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
  • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EPCLUSA and certain other medicines may affect each other, or may cause side effects.

What are the possible side effects of EPCLUSA?

Serious side effects may also include:

  • Slow heart rate (bradycardia): EPCLUSA, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with EPCLUSA and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.

The most common side effects of EPCLUSA include headache and tiredness. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Please see Important Facts about EPCLUSA including Important Warning.

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

Important Safety Information

What is the most important information I should know about EPCLUSA?

EPCLUSA can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting EPCLUSA treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with EPCLUSA. This may cause serious liver problems including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking EPCLUSA.

What should I tell my healthcare provider before taking EPCLUSA?

  • Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection or liver problems other than hepatitis C infection; if you have severe kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if EPCLUSA will harm your unborn baby or pass into your breast milk. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
  • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EPCLUSA and certain other medicines may affect each other, or may cause side effects.

What are the possible side effects of EPCLUSA?

Serious side effects may also include:

  • Slow heart rate (bradycardia): EPCLUSA, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with EPCLUSA and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.

The most common side effects of EPCLUSA include headache and tiredness. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Please see Important Facts about EPCLUSA including Important Warning.

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