9 Harvoni Side Effects You Should Know About

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). It’s also a curable condition. Several medications, known as direct-acting antivirals (DAAs), can treat hepatitis C infections. They’re prescribed based on what type of hepatitis C virus you have.

Harvoni (ledipasvir / sofosbuvir) is a combination DAA that’s FDA approved to treat certain types of chronic hepatitis C in adults and children ages 3 years and older. In most cases, you’ll take Harvoni for 12 to 24 weeks. So it’s helpful to know what side effects you may experience along the way.

Harvoni side effects at a glance

Below are some common and rare Harvoni side effects to be aware of. Keep in mind this isn’t a comprehensive list. It’s best to discuss any side effects you experience while taking Harvoni with your healthcare team.

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Common or mild Harvoni side effects include:

• Fatigue

• Weakness

• Headache

• Nausea

• Diarrhea

• Insomnia

• Cough

• Muscle pain

• Irritability

• Depression

• Dizziness

Rare but serious Harvoni side effects include:

• Allergic reactions, including skin rashes with blisters and swelling of the face, neck and mouth (angioedema)

• Suicidal thoughts

• Lung problems

Harvoni also has a boxed warning, the FDA’s strictest warning for medications. Harvoni may reactivate or worsen hepatitis B, a different type of liver infection. Because of this, you’ll be tested for hepatitis B before starting Harvoni. Your healthcare team will also keep an eye out for signs and symptoms of hepatitis B during and after Harvoni treatment.

Let’s look at nine Harvoni side effects in more detail.

Good to know: In some cases, you’ll need to take ribavirin (Rebetol), another antiviral, along with Harvoni. Ribavirin has its own side effects, so be sure to talk to your prescriber about what to expect if you’re taking Harvoni and ribavirin at the same time.

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1. Weakness and fatigue

You may feel weak or have less energy than usual while taking Harvoni. These side effects are usually mild. But it may feel harder for you to exercise or even perform daily tasks.

You can help manage fatigue during hepatitis C treatment by getting plenty of rest and eating nutritious meals to give your body more energy. Regular exercise can also give you an energy boost and improve your strength.

Ask family or friends to help with daily chores, and consider reducing your work schedule, if possible. The extra support can give you more time to rest during treatment. Let your prescriber know if fatigue is worsening or affecting your ability to care for yourself.

2. Headache

Headache is one of the most common Harvoni side effects. Up to 29% of people reported this side effect in studies.

Medication-free strategies may help you manage headaches. This includes getting enough sleep, drinking plenty of fluids, and avoiding alcohol.

Talk to your healthcare team about which over-the-counter (OTC) pain relievers are safest for your headache pain. Acetaminophen (Tylenol) can be hard on your liver at higher doses. And sometimes nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen (Aleve), should be avoided if you have liver problems.

If your headache feels severe or isn’t going away, reach out to your healthcare team for advice.

3. Nausea

Nausea isn’t a common Harvoni side effect. But it’s more likely the longer you take it. And if you’re taking Harvoni oral pellets, they can leave a bitter aftertaste in your mouth, which can lead to nausea for some people.

You can take Harvoni with or without food. But taking it with food may help prevent or minimize nausea. If you’re taking the oral pellets, be sure to mix them with soft food and swallow without chewing to help avoid the unpleasant aftertaste.

If you’re still having trouble with nausea from Harvoni, try eating smaller, more frequent meals. Skip spicy or fried foods, and try natural remedies, such as ginger or peppermint.

4. Diarrhea

Another possible Harvoni side effect is diarrhea. Like nausea, it’s more likely if you need to take Harvoni for 24 weeks. But you shouldn’t stop taking Harvoni early unless your prescriber tells you to. This could leave your hepatitis C infection untreated.

Be sure to stay hydrated and try sticking to bland foods for a day or two. If diarrhea continues or worsens, talk to your healthcare team about the best treatment option.

5. Insomnia

It’s not common, but you may have trouble sleeping (insomnia) while taking Harvoni.

The first step to managing insomnia is making sure you’re practicing good sleep hygiene. Go to bed at the same time every day and avoid screens at least an hour before bedtime. You can also try incorporating more relaxing activities, such as meditating or reading a book, to help you wind down before bed.

For occasional insomnia, an OTC sleep aid may help. Just make sure your healthcare team OKs it first. If insomnia becomes a daily issue, talk to your prescriber. They can help decide on the best way to manage it based on your medical history.

6. Cough

If you develop a cough while taking Harvoni, it’s best to check in with your prescriber. In most cases, it’s not anything serious. It’s not included in the package insert, but there have been rare reports of lung disease while taking Harvoni. And a cough could be an early sign of this side effect. So it’s best to have it checked by a medical professional to make sure there isn’t something serious going on.

Once you’ve been cleared by a professional, if your cough persists, try drinking more fluids or adding moisture to the air with a humidifier. Cough drops may also help.

7. Muscle pain

Muscle pain is a possible side effect of Harvoni. It’s also a symptom of hepatitis C. So it may be unclear if the medication or the condition is to blame.

The following tips may help ease muscle pain:

• Apply a warm compress.

• Stay hydrated. Not drinking enough fluids can lead to dehydration, which can worsen muscle pain and cramping.

• Exercise regularly. Be sure to warm up beforehand and cool down afterward.

• Move and stretch your body at least once every hour.

• Try a topical OTC product for muscle pain.

If these tips aren’t helpful or muscle pain worsens, talk to your prescriber. They can recommend other treatment options. Or a different antiviral treatment may be a better option for you.

8. Dizziness

Some people experience dizziness while taking Harvoni. But dizziness is less common than other side effects. Move slowly, especially when sitting up or standing after lying down. And stay hydrated, since dehydration can cause dizziness in some cases. Be sure to avoid driving or other activities that require coordination until you know how Harvoni affects you.

Talk to your healthcare team if dizziness becomes frequent or severe. They can help determine the cause and what to do for it.

Good to know: Dizziness can be a symptom of a slow heart rate (bradycardia). This and other serious heart problems can happen if you take Harvoni with a heart medication called amiodarone (Pacerone). So it’s not recommended to take the two medications together. If you’re taking amiodarone, make sure your prescriber knows before you start Harvoni. And if you have dizziness along with chest pain or trouble breathing, seek medical care right away (even if you aren’t taking amiodarone).

9. Mood changes

You may notice mood changes, such as irritability or depression, while taking Harvoni. Rarely, suicidal thoughts and behaviors have also been reported. Studies are conflicting as to whether or not DAAs such as Harvoni cause or worsen mood-related symptoms. It’s possible that these mood changes are related to the stress that comes with hepatitis C, rather than the treatment itself.

If you notice changes in your mood while taking Harvoni, talk to a healthcare professional. They can help determine the cause and get you the support you need to start feeling more like yourself again.

If you or someone you know is having thoughts of suicide, you’re not alone, and help is available. Call the National Suicide Prevention Lifeline at 988, or text “HOME” to 741-741 to reach the Crisis Text Line.

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Written by:

Patricia Weiser, PharmD

Patricia has 16 years of pharmacist experience. She previously held positions as a community pharmacist, pharmacy manager, and hospital pharmacist.

Edited by:

Stacia Woodcock, PharmD

Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.

Reviewed by:

Tegan Smedley, PharmD, APh

Tegan Smedley, PharmD, APh, has 10 years of experience as a pharmacist. She has worked in a variety of settings, including retail, hospital, and ambulatory care.

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