Buprenorphine / Naloxone

generic for Bunavail

Buprenorphine / Naloxone Side Effects

Drowsiness, dizziness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist right away.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe (possibly fatal) breathing problems can occur if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other opioids).

Tell your doctor right away if any of these unlikely but serious side effects occur: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, signs of your adrenal glands not working well (such as unusual tiredness, weight loss).

Although this medication is used to prevent withdrawal reactions, it may rarely cause opioid withdrawal symptoms, including diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness. This is more likely when you first start treatment or if you have been using long-acting opioids such as methadone. If such symptoms occur, notify your doctor or pharmacist right away.

Get medical help right away if any of these rare but serious side effects occur: fainting, fast/irregular heartbeat, severe dizziness, slow/shallow breathing, unusual drowsiness/difficulty waking up.

This drug may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, loss of appetite, persistent nausea/vomiting, yellowing eyes/skin, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
  • infection
  • adrenocortical insufficiency
  • androgen deficiency
  • libido changes
  • depression
  • eye tearing
  • orthostatic hypotension
  • vasodilation of blood vessels
  • pharyngitis
  • rhinitis
  • respiratory depression
  • sore tongue
  • dyspepsia
  • constipation
  • hepatic failure
  • hepatitis
  • hepatorenal syndrome
  • erectile dysfunction
  • back pain
  • abscess
  • drowsy
  • dizziness
  • insomnia
  • sleep apnea
  • fever
  • flu-like symptoms
  • hyperhidrosis
  • pain
  • chills
  • peripheral edema
  • headache disorder
  • cough
  • nausea
  • vomiting
  • diarrhea
  • abnormal hepatic function tests
  • CNS depression
  • nervousness
  • anaphylaxis
  • hypersensitivity drug reaction
  • infertility
  • general weakness
  • acute abdominal pain
  • jaundice
  • oral hypoesthesia
  • erythema of mouth mucous membrane
  • symptoms of anxiety

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this medication include: naltrexone, certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine).

Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Tell your doctor or pharmacist if you are taking other products such as alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Deaths have occurred when this medication has been misused by injecting it ("shooting up"), especially when used in combination with benzodiazepines (such as diazepam) or other depressants such as alcohol or additional opioids.