Home Consiglio Medico Malattie & Sintomi Side Effects of Zubsolv: What You Need to Know

Side Effects of Zubsolv: What You Need to Know

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Introduction

If you’re looking at treatments for opioid use disorder (OUD), your doctor may recommend Zubsolv (buprenorphine and naloxone). This prescription drug can help decrease the symptoms of withdrawal. You may have such symptoms when you stop taking opioid drugs.

Zubsolv is a tablet that dissolves under your tongue. You may take Zubsolv a few times on your first day of treatment. After your first day, you’ll likely take Zubsolv once daily.

Usually, Zubsolv is a long-term treatment for OUD. But your doctor may decrease your dose over time, so you might be able to stop taking this medication.

For more information about Zubsolv, see this in-depth article on the drug.

Like many other drugs, Zubsolv can cause mild or serious side effects. Keep reading to learn more.

What are the more common side effects of Zubsolv?

Some people may experience mild or serious side effects during their Zubsolv treatment. Examples of Zubsolv’s more commonly reported side effects include:

  • headache*
  • nausea, vomiting, or constipation*
  • sweating more than usual
  • withdrawal symptoms*
  • belly pain

* To learn more about this side effect, see “Side effects explained” below.

For information on the mild and serious side effects that may occur while you’re taking Zubsolv, see the sections below.

What are the mild side effects of Zubsolv?

Zubsolv may cause side effects during treatment. Some of the side effects that you have may be mild. Examples of mild side effects that have been reported with Zubsolv include:

  • headache*
  • nausea, vomiting, or constipation*
  • sweating more than usual
  • trouble falling or staying asleep
  • belly pain
  • swelling of the arms or legs
  • withdrawal symptoms*

* To learn more about this side effect, see “Side effects explained” below.

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop using Zubsolv unless your doctor recommends it.

Zubsolv may cause mild side effects other than the ones listed above. See the Zubsolv medication guide to learn more.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Zubsolv, visit MedWatch.

What are the serious side effects of Zubsolv?

In addition to common side effects, Zubsolv may also cause more serious side effects. Serious side effects from taking this drug are rare. But it’s important to know which serious side effects to look out for while taking this medication.

Serious side effects that have been reported with Zubsolv include:

  • respiratory depression*
  • increased pressure in your head
  • increased blood pressure in your liver or gallbladder
  • adrenal insufficiency (low levels of a hormone called cortisol)
  • liver damage or hepatitis
  • allergic reaction*†
  • orthostatic hypotension (a decrease in your blood pressure when changing positions)
  • central nervous system depression (decreased function of the brain and spinal cord)

* To learn more about this side effect, see “Side effects explained” below.
† There have been reports of allergic reaction occurring in people using Zubsolv. But it’s unclear how often this has happened or if Zubsolv was the cause.

If you develop serious side effects while taking Zubsolv, 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.

Zubsolv and withdrawal and dependence

You may have withdrawal symptoms when you stop using opioids and start Zubsolv. You may also have some withdrawal symptoms while taking Zubsolv, especially if your dose is too low. Opioid withdrawal may occur when your body becomes used to having a certain amount of opioid, and you’re taking less.

Symptoms of opioid withdrawal may include vomiting, sweating more than usual, and feeling generally unwell. For more information on withdrawal symptoms that you may have while taking Zubsolv, see the “Side effects explained” section below.

Buprenorphine, one of the active ingredients in Zubsolv, is itself an opioid (though one that isn’t as strong as other opioids). Because of this, if you suddenly stop taking Zubsolv, you may have withdrawal symptoms.

If you feel that you’re having symptoms of withdrawal during your treatment, talk with your doctor. They may monitor your symptoms or increase your dose.

It’s also possible to develop dependence on Zubsolv. “Dependence” means that your body becomes used to taking a certain drug each day. As a result, your body needs the drug to feel normal.

If you have any questions about withdrawal or dependence occurring while you’re taking Zubsolv, talk with your doctor.

FAQs about Zubsolv’s side effects

Below are the answers to some frequently asked questions about the side effects of Zubsolv.

Will I gain or lose weight during my Zubsolv treatment?

Although uncommon, it’s possible for you to gain or lose weight during treatment with Zubsolv.

Changes in weight weren’t reported as a side effect in studies of people using Zubsolv. But weight gain may occur due to lifestyle changes after starting treatment for opioid use disorder (OUD). As part of your treatment for OUD, you may make lifestyle improvements such as eating healthier. This may cause your weight to change.

One side effect of Zubsolv is swelling of the arms or legs, which is called peripheral edema. This swelling may result in an increase in your body weight. One study of people taking buprenorphine and naloxone (the two active ingredients in Zubsolv) did report weight gain as a side effect.

You may also have weight loss while you’re taking Zubsolv. Weight loss can occur from other side effects that you have with Zubsolv. For example, if you experience nausea and vomiting while taking Zubsolv, you may not be able to keep food down. This could cause you to lose weight. Weight loss can also be a symptom of more serious side effects, such as liver problems.

If you have unexpected changes in your weight while you’re taking Zubsolv, talk with your doctor. They should be able to find out what’s causing your weight changes. They can then suggest ways to help you maintain a healthy weight during your treatment.

How do the side effects of Zubsolv and Suboxone compare?

Zubsolv and Suboxone both contain buprenorphine and naloxone, so they also may cause similar side effects. Examples of side effects that may occur with either drug include:

  • nausea, vomiting, or constipation
  • trouble falling or staying asleep
  • swelling of the arms or legs
  • withdrawal symptoms
  • respiratory depression
  • liver problems

For more information about how Zubsolv compares with Suboxone, see “Zubsolv vs. Suboxone” in this article.

If you have any questions about which drug is best for treating your OUD, talk with your doctor. Although both drugs contain the same active ingredients, you may benefit more from one medication over the other.

Does Zubsolv cause any long-term side effects?

It’s uncommon for Zubsolv to cause long-term side effects. Most side effects that you may have from taking Zubsolv will go away after you stop taking the medication.

However, though rare, certain side effects of Zubsolv may cause long-term issues. This includes liver problems, such as liver damage.

Most side effects that people have with Zubsolv only happen while they’re taking the drug. After stopping Zubsolv, the side effects that you have from taking the drug will usually go away. But in some rare cases, side effects may remain even after you stop taking Zubsolv.

If you’re concerned about long-term side effects during Zubsolv treatment, talk with your doctor. They’ll monitor you for side effects during your treatment. If you have bothersome side effects from this drug, they may recommend a different treatment for your OUD.

Can Zubsolv cause vision problems?

Zubsolv doesn’t directly cause any vision problems. But it can cause a decrease in central nervous system (CNS) activity, which is called CNS depression. A symptom of CNS depression is blurred vision. Other symptoms may include feeling confused, having slurred speech, or feeling very tired.

CNS depression may be dangerous. If you have any symptoms of this condition, including blurred vision, contact your doctor.

Will I experience any emotional side effects while using Zubsolv?

Emotional side effects weren’t commonly reported in people taking Zubsolv. But some emotional side effects were reported in studies of people taking buprenorphine, one of the active ingredients in Zubsolv. Such side effects include anxiety, depression, and nervousness.

Emotional side effects may also occur in people having withdrawal symptoms. Withdrawal may cause you to feel anxious.

If you have any emotional side effects during your treatment with Zubsolv, talk with your doctor right away. They may be able to recommend ways to decrease these side effects. If suggested treatments don’t help, your doctor may recommend a different medication for your OUD.

Warnings for Zubsolv

Zubsolv may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Zubsolv. Factors to consider include those listed below.

Liver conditions, such as hepatitis. Zubsolv may cause your liver function to decrease, which may be serious. If you have a liver condition, such as hepatitis, taking Zubsolv may make it worse.

Tell your doctor about any liver conditions that you have before you start taking Zubsolv. In certain cases, they may recommend a different medication for your opioid use disorder (OUD).

Brain injury. Zubsolv can cause an increase in the pressure of cerebrospinal fluid (which surrounds your brain and spinal cord). If you have a brain injury or another condition that affects your cerebrospinal fluid, taking Zubsolv may make your condition worse.

Before starting Zubsolv, tell your doctor about any brain conditions that you have. They may monitor you more often throughout your treatment to check the pressure of your cerebrospinal fluid.

Conditions affecting your bile tract. Zubsolv may increase the pressure inside your bile tract, which consists of ducts through which bile moves. (Bile is a fluid that helps you digest food.) If you have any conditions that affect your bile tract, Zubsolv may worsen them.

Before starting Zubsolv, be sure to discuss this risk with your doctor so that they can recommend the best treatment option for you.

Allergic reaction. If you’ve had an allergic reaction to Zubsolv or any of its ingredients, you shouldn’t take this drug. Ask your doctor which other medications are better options for you.

Lung conditions. Zubsolv can cause very serious side effects, such as respiratory depression. This side effect causes trouble breathing and may even stop you from breathing altogether. If you have any lung conditions that also affect your breathing, such as chronic obstructive pulmonary disease (COPD), taking Zubsolv may worsen your breathing even further. This can become very serious.

If you have any lung conditions, tell your doctor before starting treatment with Zubsolv. They may monitor you more often during your treatment. They may also start you at a lower dose to watch for any breathing problems that you may have.

Digestive system conditions. Zubsolv may cause you to have digestive system side effects, such as nausea, vomiting, or constipation. If you have a condition that affects your digestive system, taking Zubsolv may make it harder for your doctor to treat your condition.

Discuss any digestive system conditions that you have with your doctor before starting Zubsolv. They may be able to monitor your condition more closely.

Alcohol use and Zubsolv

You shouldn’t drink alcohol while you’re taking Zubsolv. Both alcohol and Zubsolv may cause respiratory depression. If you drink alcohol while taking Zubsolv, you may have an increased risk for trouble breathing, feeling sleepy, losing consciousness, or even death.

If you think you’ll have difficulty avoiding alcohol during Zubsolv treatment, talk with your doctor. They may recommend a different treatment option for your OUD.

Pregnancy and breastfeeding while taking Zubsolv

Below, find out about side effects that may occur if you’re taking Zubsolv while pregnant or breastfeeding.

Pregnancy

It isn’t known if Zubsolv is safe to take during pregnancy. Limited data from animal studies shows that buprenorphine, one of the active ingredients in Zubsolv, may be harmful to a developing fetus. There isn’t enough data on naloxone, the other active ingredient in Zubsolv, to determine if it may be safe during pregnancy.

Your doctor may suggest Zubsolv as a treatment option for you while you’re pregnant. If so, be sure to discuss with them the risks and benefits of taking Zubsolv during this time.

Untreated OUD during pregnancy may increase your risk for preterm birth or even pregnancy loss. Your risk for having a baby with a low birth weight is also increased. And if you begin using opioid drugs again during pregnancy, this can be especially harmful to the fetus.

But if you do take Zubsolv during your pregnancy, your baby may be born with a condition called neonatal opioid withdrawal syndrome. Symptoms of this include:

  • fussiness
  • tremors or shakes
  • vomiting
  • diarrhea
  • trouble gaining weight

Your baby’s doctor can monitor them for symptoms of neonatal opioid withdrawal syndrome and treat the condition if necessary.

If you’re pregnant or planning to become pregnant, talk with your doctor about Zubsolv treatment. Even if you’re taking Zubsolv before pregnancy, your doctor may need to change your dose during your pregnancy. They may recommend treatment throughout your pregnancy. During your pregnancy, they may monitor you often to be sure that you aren’t having withdrawal symptoms.

Breastfeeding

It isn’t known if Zubsolv is safe to take while you’re breastfeeding. Buprenorphine, one of the active ingredients in Zubsolv, is present in the breast milk of females* taking the drug. But limited data shows that a child breastfed by someone taking buprenorphine experiences no harm.

Studies suggest that naloxone, the other active ingredient in Zubsolv, isn’t absorbed well into the body. If so, not much of this drug would end up in breast milk. But it isn’t known what effects the combination of buprenorphine and naloxone may cause.

If you decide to breastfeed while taking Zubsolv, watch your child for symptoms of exposure to the drug, including drowsiness or trouble breathing. If you’re breastfeeding, talk with your doctor about whether Zubsolv may be a safe option for you. They’ll be able to recommend the best treatment options for your OUD while you’re breastfeeding.

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Side effects explained

Learn more about some of the side effects that Zubsolv may cause.

Withdrawal symptoms

Withdrawal symptoms were a common side effect for people taking Zubsolv for opioid use disorder (OUD). These symptoms are possible when you first stop using opioids and start Zubsolv. To prevent these symptoms, you’ll take your first dose of Zubsolv at least 6 hours after your last dose of opioids.

You may have withdrawal symptoms if your dose of Zubsolv is too low. Withdrawal symptoms may also occur if you stop taking Zubsolv suddenly. This is because buprenorphine, one of the active ingredients in Zubsolv, is itself an opioid (though one that isn’t as strong as other opioids).

Some symptoms of opioid withdrawal may include:

  • sweating more than usual
  • feeling unwell
  • dilated pupils
  • anxiety
  • trouble falling or staying asleep
  • nausea, vomiting, or diarrhea

What might help

If you feel that you’re having symptoms of withdrawal during your treatment, talk with your doctor. They may monitor your symptoms or increase your dose of Zubsolv.

They may also recommend ways to decrease the effects of your withdrawal symptoms. For example, if you’re having nausea and vomiting, your doctor may recommend an additional medication to treat these symptoms.

For more information on the possibility of withdrawal occurring while you’re taking Zubsolv, see the “Zubsolv and withdrawal and dependence” section above. If you still have additional questions about withdrawal, talk with your doctor.

Headache

You may have headaches while you’re taking Zubsolv. In studies, headaches were a commonly reported side effect of Zubsolv.

What might help

Talk with your doctor if you have headaches while taking Zubsolv. They may be able to recommend ways to either treat your headaches or prevent them from occurring.

Respiratory depression

Respiratory depression is a rare but serious side effect that can occur while taking Zubsolv. Symptoms of respiratory depression may include dizziness, confusion, or a slower breathing rate than normal. Although not a common side effect, respiratory depression is serious and can lead to coma or even death.

Post-marketing reports* of buprenorphine, one of the active ingredients in Zubsolv, suggest that respiratory depression occurs more often in people who:

  • take Zubsolv with another drug that can cause respiratory depression
  • take Zubsolv with alcohol
  • misuse Zubsolv by crushing it up and injecting it

So it’s important that you follow your doctor’s directions for how to take Zubsolv. Also, be sure to tell your doctor about any other medications you take. This way, they can determine if Zubsolv treatment will increase your risk for respiratory depression.

* These are reports of side effects that occurred after studies were conducted.

What might help

If you notice any signs or symptoms of respiratory depression, see a doctor right away. It’s possible for respiratory depression to lead to very serious outcomes, such as coma or death. So it needs to be treated as soon as possible.

Before you start taking Zubsolv, talk with your doctor about the possibility of respiratory depression occurring. Let them know of any other medications that you’re taking and any lung conditions that you have. If you’re at high risk for developing respiratory depression, your doctor may recommend a different medication to treat your OUD.

Digestive system side effects

Zubsolv may cause you to have digestive system side effects. Examples include nausea, vomiting, and constipation, which studies of Zubsolv found to be common side effects.

What might help

If you have digestive system side effects while taking Zubsolv, talk with your doctor. They may be able to recommend ways to decrease these side effects. They may also recommend other medications that you can take to relieve your side effects.

Allergic reaction

Like most drugs, Zubsolv can cause an allergic reaction in some people.

Symptoms can be mild or serious and can include:

  • rash
  • itchiness
  • flushing (warmth or redness/deepening of your skin color for a brief time)
  • 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 might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest an over-the-counter oral antihistamine, such as Benadryl (diphenhydramine), or a topical product, such as hydrocortisone cream, to manage your symptoms.

If your doctor confirms that you had a mild allergic reaction to Zubsolv, they’ll decide if you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms that you had a serious allergic reaction to Zubsolv, they may have you switch to a different treatment.

Keeping track of side effects

During your Zubsolv treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of drug you were taking when you had the side effect
  • how soon after starting that dose you had the side effect
  • what your symptoms were from the side effect
  • how it affected your daily activities
  • what other medications you were also taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Zubsolv affects you. And your doctor can use this information to adjust your treatment plan if needed.

Zubsolv and misuse

Since Zubsolv contains buprenorphine, which is an opioid drug, some people may try to misuse it. Misusing a drug means taking it in a way other than how it’s prescribed. It also means taking a drug prescribed to someone else.

It’s important to take Zubsolv as your doctor has prescribed it. Also, never share your prescription with others. Misuse of Zubsolv may cause withdrawal symptoms such as vomiting, sweating more than usual, or feeling unwell.

What to ask your doctor

You may have side effects while you’re taking Zubsolv. But most side effects are mild. Here are some questions that you may want to ask your doctor about Zubsolv’s side effects.

  • How do I manage side effects that I may have from Zubsolv?
  • How will my treatment plan and expected side effects change if I become pregnant while taking Zubsolv?
  • If I decide I want to stop taking Zubsolv, will I have withdrawal symptoms?
  • Does my risk for side effects increase if I’m also taking other medications or have other medical conditions?

Ask a pharmacist

Q:

Respiratory depression sounds very serious. How can I avoid this side effect, and what symptoms should I look out for?

Anonymous patient

A:

Respiratory depression can indeed be very serious, as it may lead to coma and even death. That’s why it’s important that you tell your doctor what medications and over-the-counter products you’re taking before starting Zubsolv.

While taking Zubsolv, you should avoid drugs that depress your central nervous system (CNS) unless prescribed by your doctor. Examples include:

  • benzodiazepines, such as Xanax (alprazolam) and Ativan (lorazepam)
  • other CNS depressants, such as Ambien (zolpidem) and Lunesta (eszopiclone)

And you shouldn’t drink alcohol, which is also a CNS depressant.

If you have a lung condition, such as chronic obstructive pulmonary disease (COPD), use Zubsolv with caution. It can increase your risk for respiratory depression.

Symptoms of respiratory depression that you should be aware of include dizziness, confusion, and a slower breathing rate than usual. If you think you’re experiencing respiratory depression, get emergency medical help right away.

Melissa Badowski, PharmD, MPH, FCCPAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

Healthline

Disclaimer: Healthline 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 other 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.