Sublocade (buprenorphine) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat moderate to severe opioid use disorder in people who received buprenorphine products in the past.

Sublocade works to help prevent withdrawal symptoms and cravings that can occur when you stop taking opioid drugs. Sublocade is for use in adults along with counseling and other support.

Here are some fast facts on Sublocade:

  • Active ingredient: buprenorphine
  • Drug class: partial opioid agonist
  • Drug form: liquid solution given as a subcutaneous injection

Sublocade is given once per month. Depending on your situation, your doctor may want you to use the drug long term.

As with other medications, Sublocade can cause certain side effects. Keep reading to learn about possible common, mild, and serious side effects. For a broad overview of Sublocade, read this article.

Sublocade can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But 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 Sublocade in clinical trials:

Mild side effects can occur with Sublocade use. This list doesn’t include all possible mild side effects reported with the drug. For more information, you can refer to Sublocade’s medication guide.

Mild side effects of Sublocade can include:

These side effects may be temporary, lasting a few days or weeks. But 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 side effects of the medication. If you develop a side effect while taking Sublocade and want to tell the FDA about it, visit MedWatch.

* To learn more about this particular side effect, see “Side effect specifics” below.

Sublocade may cause serious side effects. The list below may not include all possible reported serious side effects of the drug. For more information, you can refer to Sublocade’s medication guide.

If you develop serious side effects while taking Sublocade, 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 and their symptoms can include:

* To learn more about this particular side effect, see “Side effect specifics” below.
Sublocade has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.

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

Injection site reaction

Sublocade may cause injection site reactions. These are side effects that affect the skin near the area of the injection. Injection site problems were commonly reported by people who received the drug in clinical trials.

Injection site reactions may include:

  • pain
  • itching around where you received your shot
  • redness or change in skin color
  • skin hardening, possibly forming into a lump
  • swelling
  • infection

What you can do

Injection site reactions usually go away on their own. In the meantime, avoid applying skin products to your skin in the area of the injection, as this could cause further irritation. You should also avoid rubbing or massaging the area where you received your shot.

If injection site pain becomes bothersome to you, over-the-counter (OTC) pain relievers, such as ibuprofen (Motrin, Advil, others) or acetaminophen (Tylenol), may help.

If you’re not sure whether OTC pain relievers are safe for you to take, talk with your doctor. You should also talk with them if you’re concerned about any injection site reactions you may be having. They may be able to suggest other ways to ease the side effects.

Feeling sleepy or tired

It’s possible that treatment with Sublocade could cause sleepiness or tiredness. The drug could also cause you to have slow reaction times. These side effects are common, especially:

  • within the first few days after you have your first Sublocade injection
  • if your doctor increases your dose
  • if other medications you take can make you sleepy

What you can do

Because Sublocade can make you feel sleepy or tired, you shouldn’t engage in certain activities until you know how the drug will affect you. These include driving, operating machinery, and performing other activities that may be dangerous. In case you’re unable to drive after an appointment for a Sublocade injection, ask someone to drive you.

If you’re concerned about feeling sleepy or tired while being treated with Sublocade, talk with your doctor. They can suggest treatments that may help. Or, they may decide to adjust your opioid use disorder therapy, including having you stop using Sublocade.

Respiratory and central nervous system depression

If the level of Sublocade in the body becomes too high, it may cause respiratory depression. With respiratory depression, your breathing becomes shallow, slow, or weak. Rarely, your breathing could stop.

A level of Sublocade that’s too high may also cause central nervous system (CNS) depression. With CNS depression, your brain activity slows. In severe cases, CNS depression can cause you to develop delirium or coma. Delirium is confusion about what’s real.

Although rare, both respiratory and CNS depression can, in some cases, be fatal. It isn’t known how often these side effects may have occurred in people using buprenorphine (the active drug in Sublocade) in clinical trials.

Sublocade is approved to be given only by a healthcare professional. When the drug is administered this way, your risks for respiratory or CNS depression from Sublocade are low.

Most, but not all, reports of severe respiratory or CNS depression occurred in two situations. These situations were when people either self-injected buprenorphine or used buprenorphine with other drugs that can cause the serious side effects.

Symptoms of respiratory or CNS depression

Symptoms of respiratory or CNS depression can include:

  • confusion
  • extreme sleepiness
  • fainting or dizziness
  • problems with coordination
  • slow, shallow breathing
  • slurred speech

What you can do

If you develop symptoms of respiratory or CNS depression during your Sublocade treatment, call your doctor, 911, or your local emergency number right away.

It’s important you don’t take other medications that could cause respiratory or CNS depression, unless your doctor knows you’re taking Sublocade and prescribes the other drugs. These medications include:

If you drink alcohol, be sure to tell your doctor before taking Sublocade. They can help determine how much, if any, is safe for you to drink while receiving treatment with Sublocade. This is because alcohol is also a CNS depressant.

You’ll need to avoid these drugs and alcohol for a few months after your last dose of Sublocade as well, unless your doctor is aware and says it’s fine. This is because the substances can stay in your body for a few months after your last injection.

Physical dependence

The body can become physically dependent on Sublocade. Physical dependence occurs when your body gets used to having a drug. It’s not known how often this side effect may have occurred in clinical trials of Sublocade.

Because Sublocade can cause physical dependence, it’s possible to have mild withdrawal symptoms after stopping treatment with the drug. And, these symptoms may not show up until a few weeks or months after your last injection.

What you can do

At some point, you and your doctor may agree that it’s time for you to stop treatment with Sublocade. When this happens, you should be monitored for withdrawal symptoms, which can include:

  • diarrhea
  • feeling cold or hot
  • goosebumps
  • muscle aches
  • runny nose
  • shaking
  • sweating
  • watery eyes
  • vomiting

These symptoms could occur a few weeks to months after your last injection. So it’s important that your doctor continues to monitor you after your last dose of Sublocade.

Talk with your doctor about what you should do if you have withdrawal symptoms. They may recommend treatments that could ease the symptoms.

Risk of serious harm or death with injection into a vein

Sublocade has a boxed warning regarding the risk of serious harm or death if the drug is injected into a vein. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The warning alerts doctors and patients about drug effects that may be dangerous.

Sublocade is approved to be given only as a subcutaneous injection. (This is an injection just under the skin.) The drug may form a solid mass if it comes into contact with bodily fluids. Over time, the mass should shrink as your blood gradually absorbs Sublocade.

But if Sublocade is injected into a vein, the mass may form in the vein. A mass that forms in a vein may move through your bloodstream, which can be life threatening. The mass can cause damage to your tissues and organs or lead to a pulmonary embolism (a blood clot in your lungs).

REMS program

Due to the potential risks, your doctor can get Sublocade only through a special program called Sublocade Risk Evaluation and Mitigation Strategy (REMS). The drug isn’t available at retail pharmacies. For safety reasons, only trained healthcare providers who are REMS certified can give doses of Sublocade. In addition, clinics or offices where Sublocade is given must be REMS certified as well.

If you’d like more information about the Sublocade REMS program, talk with your doctor. You may also call 866-258-3905 or visit the Sublocade REMS website.

What you can do

Sublocade is approved to be given only by a trained healthcare provider. It must not be injected into a vein, and you should not self-inject Sublocade doses.

Allergic reaction

As with most drugs, Sublocade can cause an allergic reaction in some people. But it’s unknown how frequently allergic reactions may have developed after Sublocade use.

Symptoms can be mild or serious and can include:

  • rash
  • itching
  • flushing (warmth, swelling, redness, or discoloration in your skin)
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • 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 Sublocade. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Sublocade has certain warnings that may affect whether or not you can use the medication safely. Read on to learn more.

Boxed warning: Risk of serious harm or death with injection into a vein

This drug has a boxed warning for the risk of serious harm or death with injection into a vein. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Sublocade may form a solid mass if it comes into contact with bodily fluids. If the drug is injected into a vein, the mass may form in the vein. A mass that forms in a vein may move through your bloodstream, which can be life threatening. Due to the potential risks, your doctor can get Sublocade only through a special program called Sublocade Risk Evaluation and Mitigation Strategy (REMS).

For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Sublocade. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Liver problems. If you have moderate or severe liver problems, you shouldn’t use Sublocade. Studies of Sublocade in people with these problems found they had higher blood levels of the drug than usual. Also, Sublocade stayed in their body longer than usual. But it isn’t known how moderate or severe liver problems impact the safety and effectiveness of the drug. The effects weren’t observed in people with mild liver problems. So it may be safe to use Sublocade if you have a mild liver problem. Your doctor can help determine whether your liver problem is mild, moderate, or severe.

Gallbladder problems. Sublocade can make existing gallbladder problems worse. So if you have a gallbladder problem, you may not be able to safely use Sublocade. Talk with your doctor about other treatments that may be better for you than Sublocade.

Abnormal heart rhythm or rate. Sublocade may affect your heart’s electrical activity. So if you or an immediate family member has, or has had, a type of abnormal heart rhythm called long QT syndrome, Sublocade isn’t safe for you to take. (Long QT syndrome can be hereditary.) And, if you’re taking a medication for an abnormal heart rhythm or rate, you shouldn’t use Sublocade. Talk with your doctor about other treatments that may be better for you than Sublocade.

Recent head injury or brain problem. It’s possible that Sublocade can increase fluid pressure in your brain or spinal cord. If you already have a brain problem or head injury, this can be dangerous. Sublocade may also make you sleepy or make your pupils shrink. Because of this, taking the drug can make it more difficult to monitor the status of your head injury or brain problem. Talk with your doctor about other treatments that may be better for you than Sublocade.

Lung problems. Rarely, Sublocade may cause respiratory depression. If you have an existing condition that affects your breathing, you may be at higher risk. Examples of these conditions include asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea. Talk with your doctor about what treatment is right for you.

Adrenal insufficiency or Addison’s disease. Used long term, Sublocade can cause problems with your adrenal glands. If you have a history of adrenal gland problems, such as Addison’s disease, Sublocade may make your existing condition worse. Talk with your doctor about other treatments that may be better for you than Sublocade.

Allergic reaction. You shouldn’t take Sublocade If you’ve ever had an allergic reaction to Sublocade or any of its ingredients. Talk with your doctor about which other treatments are better choices for you.

Alcohol use with Sublocade

If you drink alcohol, be sure to talk with your doctor before taking Sublocade. This is because alcohol, like Sublocade, is a type of substance known as a central nervous system (CNS) depressant. Taking a CNS depressant may cause a condition called CNS depression. (For more information on CNS depression, see the “Side effect specifics” section above.)

Your doctor can help determine how much alcohol, if any, is safe for you to drink while receiving treatment with Sublocade.

Pregnancy and breastfeeding while taking Sublocade

Here’s some information on whether you can use Sublocade while pregnant or breastfeeding.

Pregnancy

If you’re receiving treatment with Sublocade during pregnancy, it’s possible that your child may develop physical dependence on the drug. This means they may be born with a condition called neonatal opioid withdrawal syndrome (NOWS) and require treatment for opioid withdrawal at birth. Symptoms of NOWS can include:

  • trouble sleeping
  • crying much more than usual
  • being easily frustrated or upset
  • not gaining weight
  • vomiting
  • diarrhea
  • shaking

In addition, receiving Sublocade for a long time can make it harder than usual to become pregnant. The drug can reduce fertility in males and females.* (Fertility is the ability to become pregnant or cause someone to become pregnant.)

Talk with your doctor if you’re pregnant or planning a pregnancy. They can advise you on the right treatment plan for you.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Breastfeeding

Sublocade can pass into breast milk. This may cause harmful effects to a breastfed child, such as severe drowsiness or trouble breathing.

Before you start using Sublocade, tell your doctor if you’re breastfeeding or plan to breastfeed. They can advise you on the best treatment plan for you.

The active drug in Sublocade is buprenorphine, which is a Schedule III controlled drug. This means it has potential for misuse and can cause physical and psychological dependence.

People prescribed a medication that contains buprenorphine, such as Sublocade, should be monitored for diversion, misuse, and addictive behaviors. (“Diversion” refers to selling or giving prescription drugs to other people.) If Sublocade is misused by being injected into a vein, there’s a risk of serious harm or death.*

The Sublocade Risk Evaluation and Mitigation Strategy Program (REMS) helps minimize the potential for diversion and misuse. Your doctor can get Sublocade only through the REMS program. The drug isn’t available at retail pharmacies. Due to safety reasons, only trained healthcare providers who are REMS certified can give doses of Sublocade. In addition, clinics or offices where Sublocade is given must be REMS certified as well.

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

* Sublocade has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section above.

Physical dependence and withdrawal symptoms

Because Sublocade can cause physical dependence, it can also cause withdrawal symptoms when you stop using the drug. It’s possible that physical dependence and the desire to avoid withdrawal (by continuing to use Sublocade) can lead to drug-seeking behavior and misuse. For more information, see “Physical dependence” in the “Side effect specifics” section above.

Sublocade can cause side effects in some people. Most side effects from Sublocade are mild, go away with time, and don’t require medical attention.

Some of the more common mild side effects of Sublocade can include:

Although rare, Sublocade can also cause serious side effects. You should talk with your doctor if you experience symptoms of:

It’s also important to be aware of a risk of serious harm or death with injection into a vein.* In addition, you should talk with your doctor if you become pregnant while receiving Sublocade injections.

If you’d like to learn more about Sublocade, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug. You can also talk with your doctor if you’re interested in more information on opioid use disorder.

* Sublocade has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section above.

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 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.