Suboxone: important safety information

Suboxone® (buprenorphine and naloxone) Sublingual Film (CIII) (“Suboxone”) is a prescription medication for adults who are dependent on opioids. It's a tablet or film that dissolves under your tongue, and it combines buprenorphine with naloxone. This page covers the most important things to know so you can take it safely.

Tell your clinician about your health

Suboxone may not be right for everyone.

(1) Before you start, tell your clinician about all of your health conditions, including:

• Liver or kidney problems
• Trouble breathing or lung problems
• An enlarged prostate gland
• A head injury or brain problem
• Trouble peeing
• A curve in your spine that affects your breathing (scoliosis)
• Gallbladder problems
• Adrenal gland problems, including Addison's disease
• Low thyroid hormone levels (hypothyroidism)
• A history of alcohol use disorder
• Mental health symptoms like hallucinations (seeing or hearing things that aren't there)

(2) Be sure to tell your clinician about any other substances or medicines you take, too, as these can interact with Suboxone in different ways.

(3) Also tell your clinician if you're pregnant, plan to become pregnant, or are breastfeeding.

• Suboxone is safe to keep taking while you’re pregnant, and babies tend to do better when their parent stays on treatment. Some babies have signs of opioid withdrawal after birth. This is called neonatal opioid withdrawal syndrome. It’s expected, it’s usually milder with buprenorphine, and the hospital knows how to treat it. You may also need extra pain relief during labor, so let your birth team know you take Suboxone.
• Taking Suboxone or other buprenorphine medications is safe while breastfeeding. National health organizations strongly encourage breastfeeding for mothers on these treatments. Very little of the medication passes into breast milk (usually less than 1 percent of your dose), and it is poorly absorbed when swallowed, so it is unlikely to affect your baby.

(4) Long-term use of opioids, including Suboxone, may cause fertility problems in both men and women. Talk with your clinician if this is a concern for you.

Store it safely

Keep Suboxone in a secure place, out of sight and reach of children, and where visitors to your home can't get to it. If a child takes Suboxone by accident, it's a medical emergency and can cause death. Call 911 right away.

Suboxone is a controlled medication, which means it can be a target for theft, so keep it somewhere safe. Never give or sell your Suboxone to anyone else. It can seriously harm or kill someone, and deaths have been reported in people who aren't dependent on opioids. Selling or giving it away is also against the law.

Get help right away if your breathing slows

Suboxone can cause serious, life-threatening breathing problems. Call your clinician right away, or call 911, if:

• You feel faint, dizzy, or confused
• Your breathing gets much slower than is normal for you

These can be signs of an overdose or another serious problem.

Be careful mixing Suboxone with alcohol and other medicines

Taking Suboxone with alcohol, benzodiazepines (like Xanax or Valium), sedatives, tranquilizers, or antidepressants can cause life-threatening breathing problems, overdose, and death. If you take any of these, ask your clinician what to do.

Call your clinician or 911 right away if you:

• Feel sleepy and uncoordinated
• Have blurry vision
• Have slurred speech
• Can't think clearly
• Have slowed reflexes or breathing

Tell your clinician about every medicine you take, including over-the-counter medicines, vitamins, and herbal supplements. Some medicines can cause serious problems when taken with Suboxone, and some doses may need to change. Check with your clinician before starting any new medicine. Be especially careful with medicines that can make you sleepy, like pain medicines, sleeping pills, anxiety medicines, antidepressants, tranquilizers, and antihistamines. It helps to keep a list of your medicines to show your clinician and pharmacist each time you get a new one.

Take it as prescribed

• Don't switch from Suboxone to another buprenorphine medicine without talking with your clinician. The amount of buprenorphine in each dose isn't the same across products, so your dose may need to be different.
• Suboxone is meant to be taken regularly, not only now and then or when you feel you need it.
• Don't stop taking Suboxone without talking with your clinician first. Over time, your body gets used to it, which is called physical dependence, and stopping can make you sick with withdrawal. Physical dependence isn't the same as addiction, and your clinician can explain the difference.
• Don't take Suboxone until the effects of other opioids (like heroin, fentanyl, hydrocodone, methadone, morphine, oxycodone, kratom, or 7-OH) have started to wear off. Taking it too soon can cause withdrawal.
• Don't inject Suboxone. Injecting it can cause overdose, death, life-threatening breathing problems, infections, and other serious health problems. It can also cause serious withdrawal symptoms like pain, cramps, vomiting, diarrhea, anxiety, trouble sleeping, and cravings.
• Don't take Suboxone if you're allergic to buprenorphine or naloxone. Serious allergic reactions, including anaphylactic shock, have happened.

In an emergency, have a family member tell the emergency department staff that you're physically dependent on opioids and taking Suboxone.

What to avoid

• Don't drive, use heavy machinery, or do anything else risky until you know how Suboxone affects you. It can make you sleepy and slow your reactions. This is more likely in the first few weeks or when your dose changes, and it can also happen if you drink alcohol or take other sedating drugs.
• Don't drink alcohol while taking Suboxone. It can cause you to pass out or even die.

Possible side effects

Common side effects include nausea, vomiting, withdrawal symptoms, headache, sweating, numb mouth, constipation, a swollen or painful tongue, more redness than usual inside your mouth, feeling lightheaded or drunk, trouble paying attention, irregular heartbeat, trouble sleeping, blurry vision, back pain, fainting, dizziness, and sleepiness. Tell your clinician about any side effect that bothers you or doesn't go away.

Serious side effects can include the following. If you notice any of these, let your Care Team know right away.

Call 911 if you or someone with you has trouble breathing, difficulty waking up, or swelling of the face or throat.

• Breathing problems. The risk of coma and death is higher if you take Suboxone with other medicines, like benzodiazepines.
• Sleepiness, dizziness, and trouble with coordination. These can be stronger if you also drink alcohol or take other medicines that make you sleepy, so let your clinician know about anything else you’re taking.
• Dependence and misuse. Like other opioids, Suboxone can be misused.
• Liver problems. Signs include the skin or the whites of your eyes turning yellow, your pee is dark, your poop is light-colored, you're less hungry than usual, or you have stomach pain or nausea.
• Allergic reaction. Signs include a rash, hives, swelling of the face, wheezing, or a drop in blood pressure and passing out.
• Opioid withdrawal. Signs include shaking, sweating more than usual, feeling hot or cold, runny nose, watery eyes, goosebumps, diarrhea, vomiting, and muscle aches.
• Low blood pressure. If you have low blood pressure, you may feel dizzy if you stand up too fast.