Suboxone Side Effects

Generic Name: buprenorphine / naloxone

Note: This document contains side effect information about buprenorphine / naloxone. Some of the dosage forms listed on this page may not apply to the brand name Suboxone.

Some side effects of Suboxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to buprenorphine / naloxone: sublingual film, sublingual tablet

Along with its needed effects, buprenorphine / naloxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking buprenorphine / naloxone:

More common
  • Cough or hoarseness
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • fever or chills
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • lower back or side pain
  • painful or difficult urination
  • sweating
Incidence not known
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine / naloxone:

Symptoms of overdose
  • Blurred vision
  • confusion
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • irregular, fast, slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • pinpoint pupils
  • relaxed and calm feeling
  • sleepiness
  • unusual tiredness or weakness

Some side effects of buprenorphine / naloxone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • difficulty having a bowel movement (stool)
  • lack or loss of strength
  • nausea
  • pain
  • trouble sleeping
  • vomiting
Less common
  • Back pain
  • diarrhea
  • runny nose
  • sneezing
  • stuffy nose

For Healthcare Professionals

Applies to buprenorphine / naloxone: sublingual film, sublingual tablet

General

Side effects affecting the body as a whole in opioid dependent patients have included asthenia (6.5% vs 6.5% with placebo), chills (7.5% vs 7.5% with placebo), headache (36.4% vs 22.4% with placebo), infection (5.6% vs 6.5% with placebo), pain (22.4% vs 18.7% with placebo), abdominal pain (11.2% vs 6.5% with placebo), back pain (3.7% vs 11.2% with placebo), and withdrawal syndrome (25.2% vs 37.4% with placebo).

Chronic administration of buprenorphine may result in dependence and withdrawal symptoms may occur upon abrupt withdrawal. The naloxone component may produce severe withdrawal symptoms if buprenorphine-naloxone is injected by opioid-dependent individuals. Sublingual buprenorphine-naloxone may also cause withdrawal symptoms if taken before the opioid agonist effects have subsided.

Other

Neonatal withdrawal has been reported in infants of women who took buprenorphine during pregnancy.

Nervous system

Nervous system side effects in opioid dependent patients have included insomnia (14% vs 15.9% with placebo). Increased CNS depression may occur in patients receiving concurrent CNS depressants (e.g., narcotic analgesics, general anesthetics, benzodiazepines, phenothiazines, tranquilizers, sedative/hypnotics, or alcohol). Buprenorphine may elevate cerebrospinal fluid pressure. Side effects associated with buprenorphine alone have included anxiety, depression, dizziness, insomnia, nervousness, and somnolence.

Respiratory

Respiratory system side effects in opioid dependent patients have included rhinitis (4.7% vs 13.1% with placebo).

Respiratory depression has been associated with buprenorphine, particularly after intravenous administration. Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants.

Gastrointestinal

Gastrointestinal side effects in opioid dependent patients have included constipation (12.1% vs 2.8% with placebo), diarrhea (3.7% vs 15% with placebo), nausea (15% vs 11.2% with placebo), and vomiting (7.5% vs 4.7% with placebo). Buprenorphine may increase intracholedochal pressure.

Endocrine

Endocrine effects in opioid dependent patients have included sweating (14% vs 10.3% with placebo).

Hypersensitivity

Hypersensitivity reactions associated with buprenorphine have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.

Cardiovascular

Misuse of crushed buprenorphine tablets by inhalation has been associated with chest pain and acute anterior myocardial infarction in a 22-year-old male.

Cardiovascular side effects in opioid dependent patients have included vasodilation (9.3% vs 6.5% with placebo). Buprenorphine may cause orthostatic hypotension.

Ocular

Ocular side effects associated with buprenorphine may include miosis.

Hepatic

Hepatic side effects associated with sublingual buprenorphine have included cytolytic hepatitis and hepatitis with jaundice in opioid addicts. Preexisting liver dysfunction, hepatitis B or C virus infection, injectable drug use, or concomitant hepatotoxic drugs may have had contributory roles. Baseline and periodic monitoring of liver function tests is recommended during therapy. Close monitoring or careful discontinuation is recommended if a hepatic adverse reaction is suspected.

Psychiatric

Auditory and visual hallucinations have been associated with parenteral and sublingual buprenorphine.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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