Epclusa (sofosbuvir and velpatasvir) is a brand-name drug prescribed for hepatitis C in adults and some children. As with other drugs, Epclusa can cause side effects, such as headache and fatigue.
Epclusa belongs to a drug class called direct-acting antiviral drugs. The drug is available in a generic version. Epclusa is available in these forms:
- oral tablets
- oral pellets
Read on to learn about potential common, mild, and serious side effects of Epclusa. For a general overview of the drug, including details about its uses, see this article.
Epclusa can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Epclusa in clinical trials:
- fatigue
- nausea
- lack of energy
- headache*
- problems sleeping*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Epclusa treatment. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Epclusa’s prescribing information.
Mild side effects that have been reported with Epclusa include:
- fatigue
- feeling irritable
- lack of energy
- nausea*
- headache*
- problems sleeping*
- diarrhea*
- mild allergic reaction*
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Epclusa and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
Epclusa may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Epclusa’s prescribing information.
If you develop serious side effects while taking Epclusa, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- Anemia (low red blood cell level). Symptoms can include:
- shortness of breath
- racing heartbeat
- skin tone that looks more pale than usual
- dizziness
- Depression. Symptoms can include:
- feeling helpless
- feeling angry or irritable
- problems sleeping
- thoughts about harming yourself
- Increases in certain lab test values, such as lipase and creatine kinase. Symptoms can include:
- chest pain
- difficulty breathing
- abdominal pain
- nausea or vomiting
- Risk of reactivation of hepatitis B virus.*
- Severe allergic reaction.†
* Epclusa has a
† An allergic reaction is possible after using Epclusa. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
In clinical trials, children ages 6 years and older who took Epclusa had similar side effects to adults. However, children ages 3 years and up to 6 years reported vomiting and spitting out the drug more often than adults.
If you have questions about what side effects to expect for your child, talk with their doctor.
Epclusa may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Can Epclusa cause long-term side effects?
Epclusa is not known to cause long-term side effects.
However, if you have cirrhosis (scarring of the liver), you may continue to have symptoms of liver damage after the hepatitis C virus has been cleared. (Epclusa is used to treat hepatitis C in people with or without cirrhosis.) Your doctor will continue to monitor your liver after you stop taking Epclusa.
Talk with your doctor if you experience any side effects of Epclusa that don’t go away.
How long do side effects of Epclusa typically last?
It depends. Some of Epclusa’s side effects may be mild and go away after a few days. Others may last a few weeks.
Talk with your doctor if you experience side effects that don’t go away or are bothersome while taking Epclusa.
Is weight loss a side effect of Epclusa?
Weight loss was not reported in Epclusa’s clinical trials.
However, some people report weight loss from hepatitis C. (Epclusa is used to treat the hepatitis C virus.) Talk with your doctor if you have concerns about weight loss while taking Epclusa.
Learn more about some of the side effects that Epclusa may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Epclusa.
Risk of reactivation of hepatitis B virus
Epclusa has a
People who have both hepatitis C virus (HCV) and HBV infections can have reactivation of HBV. This happened in people who were not being treated for HBV. It can happen during or after treatment with Epclusa. In some cases, life threatening hepatitis, liver failure, and death occurred.
For this reason, your doctor will test you for hepatitis B before starting treatment with Epclusa. And they’ll monitor you closely for signs of HBV reactivation during and after treatment with Epclusa.
Symptoms of HBV reactivation include:
- vomiting
- abdominal pain
- diarrhea
- jaundice
- body aches
- fatigue
- lack of appetite
- urine that is darker in color than usual
- stools that are lighter in color than usual
What you can do
Let your doctor know if you’ve had HBV in the past. Also, talk with your doctor right away if you experience any of the side effects of HBV reactivation listed above.
Headache
In Epclusa’s clinical trials, headache was commonly reported. Symptoms of headache include:
- pain in the head or face
- a feeling of tightness around your head
What you can do
To help with symptom relief of a headache, you can try heat packs or cold packs, gentle stretching, and drinking more water.
If you have headaches that don’t improve or worsen over time, talk with your doctor. They may recommend medications, such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), to help with pain relief. It’s important not to start any new medications, including over-the-counter drugs, without talking with your doctor or pharmacist.
Diarrhea
Diarrhea was commonly reported in Epclusa’s clinical trials. Symptoms can include:
- pain in the abdomen
- gas
- increase in loose, watery stools
What you can do
To help stop diarrhea, you can try eating a bland diet. The following foods may be helpful:
- bananas
- rice
- applesauce
- toast
You can also try limiting caffeine and alcohol. Talk with your doctor if you experience diarrhea that doesn’t improve.
Problems sleeping
Insomnia was a common side effect reported in Epclusa’s clinical trials. Symptoms include:
- difficulty falling asleep or staying asleep
- waking up too early in the morning
- daytime sleepiness
- difficulty concentrating
What you can do
Talk with your doctor if you experience insomnia that doesn’t improve. Exercising during the day and limiting nighttime caffeine intake may help.
Nausea
In clinical trials of Epclusa, nausea was commonly reported. Symptoms can include:
- feeling nauseous
- pressure or pain in the abdomen
- decreased appetite
What you can do
Talk with your doctor if you have nausea that is getting worse or is bothersome. Some things that may help relieve nausea include:
- eating small meals
- sipping on cold beverages throughout your day
- avoiding spicy or greasy foods
- avoiding exercise right after eating
Allergic reaction
As with most drugs, Epclusa can cause an allergic reaction in some people. However, this side effect wasn’t reported in clinical trials.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Epclusa. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Epclusa carries a boxed warning.
Boxed warning: Risk of reactivation of hepatitis B virus
This drug has a
Other precautions
Be sure to talk with your doctor about your health history before you take Epclusa. This drug may not be the right treatment if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Slowed heart rate with certain medications. If you take amiodarone or other drugs to control your heart rate, let your doctor know before starting Epclusa. Some people taking these kinds of medications with Epclusa experienced serious heart rate problems and needed a pacemaker or other interventions. Let your doctor know about all of the medications you take. If you need to take amiodarone or other drugs to control your heart rate, your doctor may monitor you more closely while you’re taking Epclusa.
Kidney problems. If you have kidney problems, be sure to tell your doctor. Although Epclusa is safe to take if you have kidney disease, other medications that may be prescribed to treat hepatitis C may not be safe if your kidney function reaches a certain level. Tell your doctor if you have any kidney problems. They may monitor you more closely during treatment or avoid prescribing certain medications with Epclusa.
Liver problems other than hepatitis C. Be sure to tell your doctor if you have severe liver problems before starting Epclusa. Your doctor may prescribe another drug with Epclusa to treat your hepatitis C.
Allergic reaction. If you’ve had an allergic reaction to Epclusa or any of its ingredients, your doctor will likely not prescribe Epclusa. Ask your doctor about other medications that may be better options for you.
Alcohol with Epclusa
Drinking alcohol with Epclusa may increase your risk of certain side effects, including:
- nausea
- diarrhea
- headache
- fatigue
Alcohol may also worsen liver problems such as cirrhosis. For this reason, if you drink alcohol, it’s not recommended to drink it if you have hepatitis C or are undergoing treatment with Epclusa. Talk with your doctor if you have questions about how much, if any, alcohol is safe for you to drink while taking Epclusa.
Pregnancy and breastfeeding while taking Epclusa
It’s not known whether Epclusa is safe to take during pregnancy. Animal studies didn’t show fetal harm. However, animal studies don’t always predict what will happen in humans. Talk with your doctor if you are pregnant or can become pregnant. They may recommend not starting Epclusa while you are pregnant.
It’s unknown whether Epclusa passes into human breast milk. In animal studies, Epclusa passed into breast milk but didn’t cause harm. If you are breastfeeding or planning to breastfeed while taking Epclusa, talk with your doctor.
Like other drugs, Epclusa can cause side effects. Most are mild and improve over time. If you’d like to learn more about Epclusa, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Epclusa. For details about other aspects of Epclusa, refer to this article.
- Cost. If you’d like to learn about Epclusa and its cost, see this article.
- Drug comparison. To learn how Epclusa compares with Harvoni, read this article.
- A look at hepatitis C. For details about Epclusa and hepatitis C, see this article.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.