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Subutex Side Effects

Generic Name: buprenorphine

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

For the Consumer

Applies to buprenorphine: film, tablet

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

Incidence not known
  • 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 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 or hoarseness
  • difficulty having a bowel movement
  • fever
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • runny nose
  • sneezing
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • vomiting
Less common
  • Diarrhea
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • lack or loss of strength
  • sweating

For Healthcare Professionals

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


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]


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]


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]


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]


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]


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]


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]


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]


QT prolongation has been observed. In clinical trials of buprenorphine (the active ingredient contained in Subutex) 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]

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]


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]


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]


Common (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Dehydration, loss of appetite, weight decreased
Postmarketing reports: Neonatal feeding disorder[Ref]


Common (1% to 10%): Lymphadenopathy


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]

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


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]


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]


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]


1. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP, Stamford, CT.

2. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Sublocade (buprenorphine)." Reckitt Benckiser Pharmaceuticals Inc, Richmond, VA.

6. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceutical, Richmond, VA.

7. "Product Information. Probuphine (buprenorphine)." Braeburn Pharmaceuticals, Princeton, NJ.

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.