If you’re receiving treatment for opioid use disorder, your doctor may suggest that you take Sublocade (buprenorphine). Knowing the possible side effects of this drug can help you and your doctor decide whether to add it to your treatment plan.

As part of a treatment plan, Sublocade is effective at reducing opioid use in adults. Sublocade decreases withdrawal symptoms that can happen when you stop taking opioid drugs. Examples of opioids include oxycodone and heroin.

Sublocade is given as a once-a-month injection just under the skin of your belly. Depending on your situation, you may use this drug long term.

For more information on Sublocade, read this in-depth article.

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

Sublocade may cause side effects in some people. The more common side effects include:

Your doctor will recommend Sublocade if they feel that the benefits you may gain from it outweigh your risk for side effects.

Read on to learn about some potential mild and serious side effects of Sublocade.

Sublocade can cause mild side effects. These may include:

For more information on constipation and injection site reaction, see the “Side effects explained” section below.

To learn more about the mild side effects that Sublocade may cause, read the drug’s medication guide.

Though rare, serious side effects can happen with Sublocade. To help lower the risk of these side effects, a healthcare provider will give you your Sublocade injections. (Self-injecting isn’t an option for this drug.)

Your risk for serious side effects is higher if you take certain other medications or drink alcohol during Sublocade treatment. (For more information about drinking alcohol while taking Sublocade, see “Alcohol and Sublocade” in the “Warnings for Sublocade” section below.)

Serious side effects can include:

For more information about respiratory depression, physical dependence, and allergic reaction, see the “Side effects explained” section just below.

If you have symptoms that feel serious or life threatening, call 911 or your local emergency phone number to get medical care right away.

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

Injection site reaction, such as redness or pain

Sublocade may cause side effects at the site where it’s injected. In studies of Sublocade, injection site reactions were commonly reported.

Injection site reactions affect the skin in the area of the injection and may include:

  • pain
  • itching
  • redness
  • hardening
  • swelling
  • infection

What might help

Injection site reactions usually go away on their own. To avoid further irritating your skin in the area of the injection, don’t apply any skin products there. You also shouldn’t rub or massage the area.

If you have injection site pain that’s bothersome, you may find relief with over-the-counter (OTC) pain relievers such as acetaminophen (Tylenol) or ibuprofen (Motrin).

If you’re not sure whether you can safely take OTC pain relievers, or if they don’t relieve your pain, call your doctor. Also, call your doctor if you’re concerned about other injection site reactions you might be having. They may be able to suggest other ways to relieve these side effects.

Constipation

Constipation may happen with Sublocade treatment. In studies of Sublocade, constipation was commonly reported.

Symptoms of constipation include pain during bowel movements, hard stool, and a feeling of fullness, even after a bowel movement.

What might help

If you become constipated while receiving Sublocade treatment, try drinking more water and exercising. Staying hydrated and getting regular physical activity can help with constipation.

But if these remedies don’t work for you, there are others you can try.

OTC treatments, such as fiber supplements, stool softeners, and laxatives, are also effective options. Ask your doctor or pharmacist which ones may be better choices for you.

Respiratory depression

Respiratory depression (slowed breathing) is a rare but serious side effect of Sublocade. It can lead to loss of consciousness, coma, and even death.

Symptoms of respiratory depression can include daytime sleepiness, shallow breathing, headache, and confusion.

What might help

To reduce your risk for respiratory depression with Sublocade, it’s important to avoid drinking alcohol or taking any medications that affect your central nervous system. Examples of these include:

If you’re taking Sublocade, don’t take these drugs or drink alcohol unless your doctor has said that it’s OK for you to do so. Also, don’t take other medications with Sublocade without first talking with your doctor or pharmacist.

You’ll also need to avoid the drugs listed above for a few months after you stop taking Sublocade. This is because Sublocade stays in your body for a few months after you receive your last injection.

Physical dependence

Your body may become physically dependent on Sublocade. (This means that your body gets used to having the drug.) Stopping Sublocade treatment may cause withdrawal symptoms that can occur weeks to months later.

It’s possible that physical dependence, and the desire to avoid withdrawal, can lead to drug-seeking behavior and misuse.

What might help

You shouldn’t abruptly stop taking Sublocade. If you and your doctor decide that you should stop Sublocade treatment, they’ll monitor you for withdrawal symptoms for a few months. Talk with your doctor to come up with the best treatment plan for you.

Risks if Sublocade is injected into a vein

Sublocade has a boxed warning for risk of serious harm or death when injected into a vein. This is the most serious warning from the Food and Drug Administration (FDA).

When Sublocade is injected, it turns into a solid mass in your body. If the solid mass forms in a vein, it can move through your bloodstream. As a result, the mass can cause tissue damage or block the blood supply to vital organs. This may lead to serious harm or death.

To avoid these risks, you’ll get Sublocade as an injection just under the skin of your belly.

What might help

Never inject Sublocade into your vein. And avoid giving yourself any kind of Sublocade injection. Only a licensed healthcare provider can give you a Sublocade injection.

In fact, your doctor can only get Sublocade through a drug safety program called the Sublocade Risk Evaluation and Mitigation Strategy (REMS) program. This means that only healthcare providers certified by the REMS program are able to get, prescribe, and give Sublocade.

The doctor’s office or hospital where you receive your Sublocade injections must also be certified through the REMS program.

For more information about this program, talk with your doctor. You can also visit the Sublocade REMS website or call 866-258-3905.

Allergic reaction

Like most drugs, Sublocade can cause an allergic reaction in some people. It isn’t known how often people have allergic reactions after they’ve taken Sublocade. Symptoms can be mild or serious and may include:

  • rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)
  • 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 OTC oral antihistamine, such as diphenhydramine (Benadryl), or topical product, like hydrocortisone cream, to manage your symptoms.

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

Get answers to some frequently asked questions about Sublocade’s side effects.

Can Sublocade injections cause lumps?

Yes, you may notice a lump under your skin at the site where you got your Sublocade injection.

Your healthcare provider will give you your Sublocade injection just under the skin of your belly. After it’s injected, Sublocade turns into a solid mass in your body. So, you may notice a small lump in the area of the injection.

Over the course of several weeks, this lump slowly releases medication into your body. The lump will get smaller or go away as the time for your next Sublocade injection gets closer.

You shouldn’t rub or massage the lump because this could disturb the medication’s release. For the same reason, you should avoid wearing clothes that rub against the injection site.

Does Sublocade cause liver problems?

Yes, Sublocade may cause liver problems. In studies, acute hepatitis and other liver problems have been reported in adults receiving Sublocade treatment. It’s important to note that these side effects appear to be rare.

Call your healthcare provider right away if you notice any symptoms of liver problems, such as:

If you’re taking Sublocade, your doctor will likely monitor you for liver damage. They’ll do this by checking the levels of liver enzymes in your blood. High levels of liver enzymes can be an early sign of liver damage.

If your liver enzyme levels become high, you may need to change your treatment plan or stop Sublocade treatment.

While receiving Sublocade treatment, can I take pain relievers in an emergency or if I’m having a procedure?

Yes, it’s likely safe to use certain medications to relieve pain while taking Sublocade. You may be able to take non-opioid pain relievers such as acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin) or naproxen (Aleve).

But it’s not safe to take opioids for pain relief. Taking opioids with Sublocade treatment can increase your risk for life threatening side effects. These include respiratory depression (slowed breathing) and loss of consciousness.

In a medical emergency or if you’re having surgery, you should tell medical staff that you take Sublocade. They’ll be able to monitor your breathing while the drug is in your body.

Also, opioids can be less effective at relieving pain when Sublocade is in your system. Even when you stop Sublocade treatment, the drug remains in your body for a few months after your last dose.

Can I drive myself to and from my appointment to have Sublocade injected?

Maybe, but it depends on how Sublocade affects you. The drug may make you sleepy and could slow down your ability to think and react. This might make driving very dangerous.

For your first few appointments, you should arrange for someone else to drive. Same goes if your doctor increases your dose of Sublocade.

For the first few days after your injection, you shouldn’t plan to drive or operate heavy machinery. Wait to see how Sublocade makes you feel.

Can I take over-the-counter cold or allergy medications while receiving Sublocade treatment?

Some over-the-counter cold and allergy medications contain antihistamines such as diphenhydramine (Benadryl). Because these drugs may cause drowsiness, you should avoid them while you’re taking Sublocade, unless your doctor says that a specific medication is OK to use alongside Sublocade.

Talk with your doctor or pharmacist to find out which cold or allergy medications are safe for you to take.

Sublocade may not be safe for everyone who has opioid use disorder. Your doctor will help you decide if Sublocade is the best treatment option for you.

Boxed warning: Risk of serious harm or death when injected into a vein

Sublocade has a boxed warning for risk of serious harm or death when injected into a vein. This is a serious warning from the Food and Drug Administration (FDA).

Sublocade becomes a solid mass after it’s injected. If the mass forms in a vein, it can move through the bloodstream, resulting in problems such as tissue damage. This may lead to serious harm or death. For more information about this boxed warning, see the “Side effects explained” section above.

Other warnings

Sublocade 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 Sublocade. Some factors to consider include those in the list below.

Breathing problems or lung damage. Lung disease or breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea, could increase your risk for severe side effects. These include respiratory depression.

Tell your doctor about any lung problems you have. They may suggest a treatment other than Sublocade for your condition.

Use with medications that affect the central nervous system (CNS). Taking Sublocade with CNS depressants may lead to coma and even death. Examples of CNS depressants include benzodiazepines, muscle relaxers, and sleep aids.

For your safety, review every medication you’re taking with your doctor before you start taking Sublocade. They may decide that you shouldn’t use any medication that may cause drowsiness while taking Sublocade.

Before using any new medications with Sublocade, check with your doctor or pharmacist.

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

Liver problems. People with moderate to severe liver damage shouldn’t use Sublocade. Studies of the drug found that people with moderate to severe liver problems had higher blood levels of Sublocade, and the drug stayed in their body longer.

It isn’t known how the safety and effectiveness of the drug is affected by moderate or severe liver problems. If you have liver problems, your doctor can help determine whether they’re moderate or severe.

Also, Sublocade may increase liver enzyme levels. This could lead to more damage to the liver.

If you’re taking Sublocade, your doctor will monitor your liver enzyme levels. If your liver enzyme levels become too high, you may need to change your treatment plan or stop Sublocade treatment. Your doctor will also watch for any signs that Sublocade levels in your body are getting too high.

Abnormal heart rate. If you or an immediately family member has had a kind of abnormal heart rate called long QT syndrome, you shouldn’t take Sublocade. You also shouldn’t take Sublocade if you use certain medications to treat an arrhythmia, such as amiodarone (Pacerone) or sotalol (Betapace). Talk with your doctor about other treatment options that may be better for you.

Gallbladder problems. Sublocade can make gallbladder problems worse. If you’ve had problems with your gallbladder, let your doctor know before starting Sublocade. They’ll monitor you closely for any worsening of your existing problems.

Adrenal gland problems. Sublocade can cause problems with your adrenal glands. If you have a history of adrenal gland problems, such as Addison’s disease, tell your doctor. They may recommend a drug other than Sublocade to treat your condition.

Alcohol use and Sublocade

You shouldn’t drink alcohol during your treatment with Sublocade. Drinking alcohol with Sublocade in your system can cause drowsiness and respiratory depression (slowed breathing). This may lead to loss of consciousness and even death.

You should also know that Sublocade stays in your body for a few months after your last dose. This means that you may need to wait for a few weeks or months after stopping Sublocade before it’s safe for you to drink alcohol.

If you drink alcohol, talk with your doctor. They may recommend a different treatment for your condition.

And if you’ve stopped Sublocade treatment and are wondering when you can safely drink alcohol, ask your doctor. They’ll be able to let you know how long after your last dose of Sublocade to wait before it’s safe to drink alcohol.

Pregnancy and breastfeeding while taking Sublocade

If you receive Sublocade treatment during pregnancy, your baby may develop a physical dependence on the drug. This means that they may be born with neonatal opioid withdrawal syndrome. As a result, they may need to receive treatment for opioid withdrawal at birth. Before starting Sublocade, talk with your doctor if you’re pregnant or planning to become pregnant.

Sublocade can pass into breast milk. This may cause harmful effects, such as severe drowsiness or trouble breathing, in a breastfed child. Before starting Sublocade, let your doctor know if you’re breastfeeding or planning to breastfeed. They’ll suggest the best options for feeding your child during Sublocade treatment.

Sublocade contains buprenorphine, which can be misused. Misusing Sublocade by injecting it into a vein may result in serious harm or death. (For more information, see “Risks if Sublocade is injected into a vein” in the “Side effects explained” section above.)

Also, your body may become physically dependent on Sublocade. (This means that your body gets used to having the drug.) Stopping Sublocade treatment may cause withdrawal symptoms that can occur weeks to months later.

It’s possible that physical dependence, and the desire to avoid withdrawal, can lead to drug-seeking behavior and misuse.

Because of this misuse risk, Sublocade is only available through the Sublocade Risk Evaluation and Mitigation Strategy (REMS) program.

This means that only healthcare providers certified by the REMS program are able to get, prescribe, and give you Sublocade. The doctor’s office or hospital where you receive your Sublocade injections must also be certified through the REMS program. (For more information about this program, visit the Sublocade REMS website or call 866-258-3905.)

You shouldn’t abruptly stop taking Sublocade. If you and your doctor decide that you should stop Sublocade, they’ll monitor you for withdrawal symptoms for a few months.

Talk with your doctor if you have any questions or concerns about stopping Sublocade.

Because Sublocade is meant to be a long-term treatment option for opioid use disorder, you may have concerns about its side effects. For most people, the side effects of Sublocade are usually mild.

If you’re considering Sublocade treatment, talk with your doctor or pharmacist about the drug’s possible side effects. Here are a few questions to get you started:

  • Am I at higher risk for side effects than others taking Sublocade?
  • Would this drug interact with any other medications I’m taking?
  • How can I manage my depression or anxiety disorder while I’m receiving Sublocade treatment?
  • What are some ways to deal with feeling tired while taking Sublocade?

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.