Zubsolv 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 Zubsolv.
Common side effects of Zubsolv include: constipation, diarrhea, headache, and nausea. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to buprenorphine / naloxone: film, tablet
Side effects requiring immediate medical attention
Check with your doctor immediately if any of the following side effects occur while taking buprenorphine / naloxone:
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- lower back or side pain
- painful or difficult urination
Incidence not known
- bloating or swelling of the face, arms, hands, lower legs, or feet
- darkening of the skin
- difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- loss of appetite
- mental depression
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- restlessness shivering talking or acting with excitement you cannot control tightness in the chest
- tingling of the hands or feet
- trembling or shaking twitching
- 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
- difficult or troubled breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular, fast, slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm feeling
- unusual tiredness or weakness
Side effects not requiring immediate medical attention
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:
- Difficulty having a bowel movement
- lack or loss of strength
- stomach pain
- trouble sleeping
Incidence not known
- Burning or sore mouth
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings inside the mouth
- decline or loss of libido or sexual desire
- mood swings
- poor concentration
- redness, swelling, or soreness of the tongue
- reduced muscle strength
- swelling, inflammation, or redness of the mouth
For Healthcare Professionals
Applies to buprenorphine / naloxone: buccal film, sublingual film, sublingual tablet
The most commonly observed adverse events included headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Additionally, oral hypoesthesia was reported with the sublingual film.[Ref]
Very common (10% or more): Pain (22.4%)
Common (1% to 10%): Asthenia, chills, pyrexia, malaise, injury, ear pain
Uncommon (0.1% to 1%): Hypothermia, heat stroke
Very common (10% or more): Headache (36.4%)
Common (1% to 10%): Migraine, dizziness, hypertonia, paraesthesia, somnolence
Uncommon (0.1% to 1%): Amnesia, convulsion, hyperkinesia, speech disorder, tremor
Postmarketing reports: Neonatal withdrawal syndrome including symptoms of hypertonia, neonatal tremor, neonatal agitation, and myoclonus; reports of neonatal convulsions, apnea, respiratory depression, and bradycardia[Ref]
Uncommon (0.1% to 1%): Yawning
Frequency not reported: Rhinorrhea
Frequency not reported: Significant respiratory depression, coma, death[Ref]
Very common (10% or more): Constipation (12.1%), nausea (15%), abdominal pain (11.2%)
Frequency not reported: Stomach discomfort,
Common (1% to 10%): Erectile dysfunction, decreased libido
Postmarketing reports: Disorders of pregnancy
Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus[Ref]
Postmarketing reports: Glossodynia, oral mucosal erythema, oral hypoesthesia, stomatitis[Ref]
Common (1% to 10%): Vasodilation, hypertension
Common (1% to 10%): Amblyopia, lacrimal disorder
In clinical trials and in postmarketing reports, cases of cytolytic hepatitis and hepatitis with jaundice have been reported in association with buprenorphine use. The spectrum of abnormalities has ranged from transient asymptomatic elevations of hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy. The presence of preexisting liver enzyme abnormalities, viral hepatitis, concomitant hepatotoxic drug use, and ongoing IV drug abuse may have played a causative or contributory role.[Ref]
Common (1% to 10%): Abnormal liver function tests
Frequency not reported: Cytolytic hepatitis, hepatitis with jaundice, transient asymptomatic elevations of hepatic transaminases, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy.[Ref]
Common (1% to 10%): Anxiety, depression, nervousness, abnormal thinking
Uncommon (0.1% to 1%): Abnormal dreams, agitation, apathy, depersonalization, drug dependence, euphoric mood, hostility
Frequency not reported: Restlessness, irritability
Postmarketing reports: Hallucination, attempted suicide, insomnia[Ref]
Very common (10% or more): Sweating (14%)
Common (1% to 10%): Pruritus, rash, urticaria, ecchymosis
Frequency not reported: Piloerection, cold sweat[Ref]
Common (1% to 10%): Urine abnormality
Common (1% to 10%): Back pain, arthralgia, muscle spasms, myalgia, rigid neck, leg cramps, joint disorder
Uncommon (0.1% to 1%): Arthritis
Frequency not reported: Arthralgia[Ref]
1. "Product Information. Bunavail (buprenorphine-naloxone)." BioDelivery Sciences International, Inc., Raleigh, NC.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. "Product Information. Zubsolv (buprenorphine-naloxone)." Orexo US, Inc, New York City, NY.
5. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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More about Zubsolv (buprenorphine / naloxone)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 107 Reviews
- Drug class: narcotic analgesic combinations
- FDA Alerts (1)
- FDA Approval History