Zubsolv Side Effects

Generic Name: buprenorphine / naloxone

Note: This page contains side effects data for the generic drug buprenorphine / naloxone. It is possible that some of the dosage forms included below may not apply to the brand name Zubsolv.

It is possible that some side effects of Zubsolv may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to buprenorphine / naloxone: film, tablet

As well as its needed effects, buprenorphine / naloxone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking buprenorphine / naloxone, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking buprenorphine / naloxone, get emergency help immediately:

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 buprenorphine / naloxone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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: buccal film, 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

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

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

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.

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