Buprenex Side Effects

Generic name: buprenorphine

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 14, 2023.

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

Applies to buprenorphine: film, tablet. Other dosage forms:

• injection solution
• intradermal implant
• transdermal patch extended release

Serious side effects of Buprenex

Along with its needed effects, buprenorphine (the active ingredient contained in Buprenex) 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:

Less common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chest tightness
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• fever
• frequent urge to urinate
• headache
• loss of appetite
• lower back or side pain
• mouth or throat pain
• nausea
• nervousness
• pale skin
• pounding in the ears
• rapid weight gain
• slow or fast heartbeat
• stomach pain
• tingling of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Rare

• Breakdown or tearing of the skin
• chills
• irregular heartbeat, recurrent
• irritation, itching, pain, redness, swelling, tenderness, or warmth on the skin
• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• Agitation
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• blurred vision
• confusion
• cough
• darkening of the skin
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• headache, severe and throbbing
• hives, skin rash
• irregular, fast, slow, or shallow breathing
• mental depression
• overactive reflexes
• pale or blue lips, fingernails, or skin
• pinpoint pupils
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• relaxed and calm feeling
• restlessness
• shivering
• sleepiness
• talking or acting with excitement you cannot control
• toothache
• trembling or shaking
• twitching
• vomiting

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

Symptoms of overdose

• Change in consciousness
• chest pain
• cold and clammy skin
• increased sweating
• coughing that sometimes produces a pink frothy sputum
• difficult or trouble breathing
• increased sweating
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• pale or blue lips, fingernails, or skin
• sleepiness or unusual drowsiness
• swelling in legs and ankles

Other side effects of Buprenex

Some side effects of buprenorphine 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

• Back pain
• chills
• cough
• difficulty having a bowel movement
• hoarseness
• painful or difficult urination
• runny nose
• sneezing
• stuffy nose
• trouble sleeping

Less common

• Anxiety
• back pain
• bruise
• decreased appetite
• fall
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• itching, skin rash
• muscle aches or spams
• pain or tenderness around eyes and cheekbones
• sore throat

Rare

• Lack or loss of strength
• muscle or bone pain
• neck pain
• stomach discomfort

For Healthcare Professionals

Applies to buprenorphine: buccal film, compounding powder, injectable solution, subcutaneous solution extended release, subdermal implant, sublingual tablet, transdermal film extended release.

General

The most common adverse reactions have included headache, insomnia, pain, signs and symptoms of withdrawal, nausea, constipation, application site pruritus, application site erythema, vomiting, hyperhidrosis, dizziness, somnolence, dry mouth, and application site rash.^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 28%), withdrawal syndrome (up to 24%), anxiety (up to 14%), depression (up to 13%)

Common (1% to 10%): Hostility, agitation, paranoid reaction, thinking abnormal, confusion

Uncommon (0.1% to 1%): Affect lability, depersonalization, libido decreased, nightmare, euphoric mood, psychosis, hallucination, euphoria

Very rare (less than 0.01%): Dependence, mood swings

Frequency not reported: Dreaming

Postmarketing reports: Neonatal withdrawal syndrome^[Ref]

Respiratory

Very common (10% or more): Rhinitis (up to 15%)

Common (1% to 10%): Cough increased, pharyngitis, upper respiratory tract infection, influenza, sinusitis, bronchitis, dyspnea, pharyngolaryngeal pain, hypoventilation, yawning

Uncommon (0.1% to 1%): Asthma aggravated, hiccups, hyperventilation, hypoxia, wheezing, apnea

Rare (less than 0.1%): Respiratory depression, respiratory failure

Postmarketing reports: Asphyxia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23%), constipation (up to 14%), abdominal pain (11.7%), diarrhea (up to 10%)

Common (1% to 10%): Vomiting, dyspepsia, dry mouth, stomach discomfort, upper abdominal pain, flatulence

Rare (0.01% to 0.1%): Diverticulitis, dysphagia, ileus, heartburn

Very rare (less than 0.01%): Retching^[Ref]

Dermatologic

Very common (10% or more): Application site pruritus (up to 15%), sweating (up to 13%), application site erythema (up to 10%)

Common (1% to 10%): Application site rash, application site irritation, hyperhidrosis, pruritus, rash, generalized pruritus

Uncommon (0.1% to 1%): Contact dermatitis, application site dermatitis, dry skin, facial edema, urticaria, pallor

Very rare (less than 0.01%): Pustules, vesicles

Frequency not reported: Injection site reaction, angioedema, application site edema^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 16%)

Common (1% to 10%): Arthralgia, pain in extremity, muscle spasm, musculoskeletal pain, joint swelling, neck pain, myalgia, chest pain, leg cramps, bone pain, general spasm, muscle weakness, increased creatine phosphokinase (CPK)

Uncommon (0.1% to 1%): Muscle cramps, rigors, muscle spasm

Very rare (less than 0.01%): Muscle fasciculation, ear pain^[Ref]

Other

Very common (10% or more): Pain (up to 26%), asthenia (up to 16%)

Common (1% to 10%): Chills, fever, accidental injury, fatigue, pyrexia, fall, malaise, tiredness, lethargy

Uncommon (0.1% to 1%): Edema

Frequency not reported: Death^[Ref]

Immunologic

Very common (10% or more): Infection (up to 22%), flu syndrome (up to 10%)

Common (1% to 10%): Abscess^[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)

Common (1% to 10%): Dizziness/vertigo, nervousness, somnolence, hypoesthesia, tremor, migraine, paresthesia, syncope, hypertonia, dysgeusia, exanthema, sedation

Uncommon (0.1% to 1%): Tinnitus, concentration impairment, coordination abnormal, dysarthria, memory impairment, restlessness, sedation, sleep disorder, slurred speech, coma

Rare (less than 0.1%): Disequilibrium, numbness

Frequency not reported: Convulsions

Postmarketing reports: Neonatal tremor, serotonin syndrome^[Ref]

Cardiovascular

Common (1% to 10%): Vasodilation, hypotension, peripheral edema, hypertension, palpitations

Uncommon (0.1% to 1%): Orthostatic hypotension, tachycardia, angina pectoris, flushing, bradycardia, cyanosis, , QT prolongation

Frequency not reported: Wenckebach block^[Ref]

QT prolongation has been observed. In clinical trials of buprenorphine buccal film (n=1590), post-baseline QTcF values of 450 to 480 milliseconds were observed in 2% of patients at doses up to 900 mcg every 12 hours. In a QT study in healthy subjects, therapeutic doses (10 mcg/hour transdermal patch) had no effect on the QTc interval, but higher doses (40 mcg/hour) were associated with a mean prolongation of 5.9 milliseconds.

During clinical trials, serial ECGs were collected to evaluate the effect of extended-release subcutaneous administration of buprenorphine on QT prolongation. Seven patients showed a greater than 60 msec increase QTc from baseline. One patient had a QTc greater than 500 msec. These QTc findings were reported as sporadic and transient and none led to aberrant ventricular rhythm. Review of ECG and adverse event data showed no evidence of syncope, seizure, or ventricular tachycardia or fibrillation.^[Ref]

Ocular

Common (1% to 10%): Runny eyes, miosis, mydriasis, lacrimation disorder

Uncommon (0.1% to 1%): Dry eye, vision blurred, conjunctivitis

Rare (less than 0.1%): Eyelid edema, visual disturbance

Frequency not reported: Diplopia, visual abnormalities, amblyopia^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea

Uncommon (0.1% to 1%): Urinary incontinence, urinary retention

Rare (less than 0.1%): Urinary hesitation, decreased erection, sexual dysfunction^[Ref]

Metabolic

Common (1% to 10%): Anorexia

Uncommon (0.1% to 1%): Dehydration, loss of appetite, weight decreased

Postmarketing reports: Neonatal feeding disorder^[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in the implant. Anaphylaxis has been reported with ingredients contained in extended-release subcutaneous injection.^[Ref]

Uncommon (0.1% to 1%): Allergic reaction

Rare (0.01% to 0.1%): Anaphylactic responses

Very rare (less than 0.01%): Serious allergic reactions^[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased gamma-glutamyl transferase (GGT)

Rare (less than 0.1%): Biliary colic

Frequency not reported: Hepatitis, jaundice, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy, transaminases increased^[Ref]

Local

Very common (10% or more): Implant site pain (13%), implant site pruritus (12%), implant site erythema (10%)

Common (1% to 10%): implant site hematoma, implant site hemorrhage, implant site edema, injection site pain, injection site pruritus, injection site erythema, injection site induration

Uncommon (0.1% to 1%): Injection site bruising, injection site swelling, injection site discomfort, injection site reaction, injection site cellulitis, injection site infection^[Ref]

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency^[Ref]

Cases of androgen deficiency have been reported with chronic use of opioids. Adrenal insufficiency has been reported with opioid use, especially with use of 1 month or longer.^[Ref]

Frequently asked questions

• Is Buprenex safe for humans?
• How long does it stay in your system?
• How long does opioid withdrawal last?
• How long does buprenorphine stay in your system?
• What are the different brands of buprenorphine?
• What are the different types of buprenorphine/naloxone?
• How long do you take buprenorphine for?
• Is Buprenex the same as buprenorphine?

Further information

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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