Subutex Side Effects

Generic name: buprenorphine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 19, 2023.

Note: This document provides detailed information about Subutex Side Effects associated with buprenorphine. Some dosage forms listed on this page may not apply specifically to the brand name Subutex.

Applies to buprenorphine: film, tablet.

Other dosage forms:

• injection solution
• intradermal implant
• transdermal patch extended release

Common side effects of Subutex

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:

Serious side effects of Subutex

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:

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

For healthcare professionals

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

Cardiovascular

• Common (1% to 10%): Circulatory collapse, circulatory disorders, ECG prolonged QT, flushing, hot flush, hypertension, hypotension, orthostatic hypotension, palpitations, tachycardia, vasodilatation, vasodilation
• Uncommon (0.1% to 1%): Angina pectoris, bradycardia, cyanosis, heat stroke, myocardial infarction, pallor, second degree atrioventricular block
• Rare (0.01% to 0.1%): Hot flushes
• Frequency not reported: Atrial fibrillation, coronary artery disease, fainting, fall in blood pressure, increased blood pressure, prolonged QTc, Wenckebach block
• Postmarketing reports: Heart rate/rhythm disorders, hypotension, orthostatic hypotension

Circulatory disorders included hypotension and rarely, circulatory collapse.

Dermatologic

• Very common (10% or more): Sweating (up to 13%), erythema, hyperhidrosis/sweating, pruritus
• Common (1% to 10%): Cellulitis, diaphoresis, exanthema, excoriation, generalized pruritus, laceration, rash, subcutaneous abscess, urticaria
• Uncommon (0.1% to 1%): Acne, alopecia, dry skin, exfoliative dermatitis, macular rash, scratch, skin lesion, skin mass
• Very rare (less than 0.01%): Pustules, vesicles
• Frequency not reported: Angioedema (Quincke's edema)/angioneurotic edema, contact dermatitis, skin discoloration, urticaria/hives
• Postmarketing reports: Angioneurotic edema, hyperhidrosis, pruritus, rash

Endocrine

• Frequency not reported: Decreased blood testosterone

Opioids:

• Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of adrenal insufficiency have been reported with opioid use, more often when used beyond 1 month. Cases of androgen deficiency have occurred with prolonged opioid use.

Gastrointestinal

• Very common (10% or more): Nausea (up to 50%), constipation (up to 14%), abdominal pain (up to 11.7%), diarrhea (up to 10.3%), dry mouth, vomiting
• Common (1% to 10%): Dyspepsia, flatulence, gastroenteritis, gastrointestinal disorder, increased lipase, oral herpes, stomach discomfort, tooth abscess, tooth disorder, tooth infection, toothache, upper abdominal pain, viral gastroenteritis
• Uncommon (0.1% to 1%): Tongue discoloration, mouth ulceration
• Rare (0.01% to 0.1%): Diverticulitis, dysphagia, ileus, pyrosis/heartburn
• Very rare (less than 0.01%): Retching
• Frequency not reported: Abdominal discomfort, abdominal distention
• Postmarketing reports: Dental decay, nausea, vomiting

According to some authorities, females reported nausea and vomiting 10% to 15% more frequently than males.

Dental decay included caries, tooth fracture, and tooth loss.

Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported after the use of transmucosal buprenorphine-containing products. Reported events included cavities, tooth decay, dental abscesses/infection, rampant caries, tooth erosion, fillings falling out, and, in some cases, total tooth loss.

Genitourinary

• Common (1% to 10%): Dysmenorrhea, erectile dysfunction, urinary aberration, urinary retention, urinary tract infection
• Uncommon (0.1% to 1%): Albuminuria, amenorrhea, dysuria, ejaculation disorder, hematuria, intermenstrual bleeding, menorrhagia, micturition disorders, urinary hesitation, urinary incontinence, vaginal infection
• Rare (0.01% to 0.1%): Decreased erection, sexual dysfunction
• Postmarketing reports: Urinary retention

Hematologic

• Common (1% to 10%): Anemia, lymphadenopathy
• Uncommon (0.1% to 1%): Leukocytosis, leukopenia, thrombocytopenia

Hepatic

• Very common (10% or more): Increased ALT (12.4%), increased AST (up to 11.4%)
• Common (1% to 10%): Abnormal liver enzymes, abnormal liver function tests, increased GGT, increased hepatic enzymes
• Uncommon (0.1% to 1%): Hepatic necrosis, hepatitis
• Rare (0.01% to 0.1%): Biliary colic
• Frequency not reported: Abnormal hepatic function, abnormal liver function test, acute hepatitis, cholecystitis, cytolytic hepatitis, hepatic abnormalities, hepatitis with jaundice, hepatorenal syndrome, increased intracholedochal pressure, increased transaminases, jaundice
• Postmarketing reports: Elevated hepatic transaminases, hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatitis, hepatorenal syndrome, jaundice

Increased ALT (greater than 3 times the upper limit of normal [3 x ULN]) and increased AST (greater than 3 x ULN) have been reported in up to 12.4% and up to 11.4% of patients, respectively.

Increased hepatic enzymes included increased hepatic enzymes, abnormal liver function test, and elevated ALT, AST, GGT, alkaline phosphatase, and/or bilirubin.

The spectrum of hepatic abnormalities ranged from transient asymptomatic elevations in hepatic transaminases to case reports of death, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy.

Hypersensitivity

• Common (1% to 10%): Hypersensitivity
• Uncommon (0.1% to 1%): Allergic reaction
• Rare (0.01% to 0.1%): Anaphylactic reaction
• Very rare (less than 0.01%): Serious allergic reactions
• Frequency not reported: Anaphylactic shock, anaphylactoid reaction, drug hypersensitivity
• Postmarketing reports: Anaphylactic shock, anaphylaxis

Cases of acute and chronic hypersensitivity to this drug have been reported in clinical trials and during postmarketing experience. The most common signs/symptoms included rashes, hives, and pruritus; cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported.

Allergic reaction included oropharyngeal swelling and swollen tongue.

Serious allergic reactions have been reported; in some cases, delayed allergic reactions occurred with marked signs of inflammation.

Local

• Very common (10% or more): Administration site reactions (up to 20.7%), application site pruritus (up to 15%), implant site pain (up to 13%), implant site pruritus (up to 12%), implant site erythema (10.4%), application site erythema, application site reaction, application site skin reactions
• Common (1% to 10%): Application site irritation, application site rash, implant site edema, implant site hematoma, implant site hemorrhage, injection site bruising, injection site erythema, injection site induration, injection site inflammation, injection site mass, injection site pain, injection site pruritus, injection site reaction, injection site swelling, injection site ulcer
• Uncommon (0.1% to 1%): Injection site cellulitis, injection site discomfort, injection site edema, injection site infection, injection site urticaria, local swelling
• Rare (0.01% to 0.1%): Administration site reactions
• Frequency not reported: Application site dermatitis, application site skin discoloration
• Postmarketing reports: Injection site abscess, injection site mass, injection site necrosis, injection site ulceration

Application site reaction included erythema, edema, pruritus, or rash at the application site.

Application site skin reactions included common signs/symptoms of contact dermatitis (irritative/allergic), erythema, edema, pruritus, rash, vesicles, and pain/burning sensation at the application site. In some cases, late-onset local allergic reactions (allergic contact dermatitis) occurred with marked signs of inflammation.

In rare cases, severe application site skin reactions with signs of marked inflammation (including burn, discharge, and vesicles) have occurred.

Cases of injection site abscess, ulceration, and necrosis have been reported after treatment initiation. Some cases required debridement and antibiotic treatment.

Metabolic

• Common (1% to 10%): Anorexia, decreased appetite/appetite loss, increased blood glucose
• Uncommon (0.1% to 1%): Dehydration, hyperglycemia, hyperlipidemia, hypoglycemia

Opioids:

• Postmarketing reports: Hypoglycemia

Cases of hypoglycemia have been reported in patients taking opioids; most reports were in those with at least 1 predisposing risk factor (e.g., diabetes).

Musculoskeletal

• Very common (10% or more): Back pain (up to 16%)
• Common (1% to 10%): Arthralgia, bone pain, increased blood creatine phosphokinase, joint swelling, leg cramps, ligament sprain, muscle spasms, muscle twitching, muscular weakness, musculoskeletal pain, myalgia, neck pain, pain in extremity
• Uncommon (0.1% to 1%): Arthritis, muscle cramps, muscle strain
• Frequency not reported: Ankle fracture, muscle aches, muscle weakness, osteoarthritis

Nervous system

• Very common (10% or more): Headache (up to 34%), dizziness (up to 15%), somnolence (up to 13%), drowsiness, sedation, sleep, vertigo
• Common (1% to 10%): Dysgeusia/taste disturbance, hypertonia, hypoesthesia, lethargy, migraine, paresthesia, speech disorders, syncope, tremor
• Uncommon (0.1% to 1%): Abnormal coordination, amnesia, coma, concentration impairment, disturbance in attention, dysarthria, dysgeusia/parageusia, exhaustion, hyperkinesia, impaired speech, lack of muscle coordination, memory impairment, paresthesia (e.g., pricking/burning skin sensation), procedural dizziness, seizure, slurred speech, tinnitus
• Rare (0.01% to 0.1%): Balance disorder, convulsions, disequilibrium, impaired concentration, numbness, seizures, speech disorder
• Very rare (less than 0.01%): Involuntary muscle contractions, muscle fasciculation
• Frequency not reported: Cerebrovascular accident, depressed level of consciousness, dysgeusia, gait disturbance, hyperalgesia, loss of consciousness, mental impairment, postural dizziness, sleep apnea syndrome, sleepiness, transient ischemic attack
• Postmarketing reports: Coma, convulsions, dizziness, headache, neonatal tremor, somnolence, vertigo

Opioids:

• Postmarketing reports: Serotonin syndrome, hyperalgesia, allodynia

According to some authorities, females reported dizziness and headache 10% to 15% more frequently than males.

In clinical studies involving 1133 patients, sedation occurred in about two-thirds of the patients.

Serotonin syndrome (a potentially life-threatening condition) has been reported during concomitant use of opioids with serotonergic drugs.

Hyperalgesia and allodynia have been reported with opioid therapy of any duration.

Ocular

• Common (1% to 10%): Amblyopia, lacrimal disorder, lacrimation disorders, miosis, mydriasis, runny eyes, tears disturbance
• Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, diplopia, dry eye, visual impairment
• Rare (0.01% to 0.1%): Eyelid edema, visual disturbance
• Frequency not reported: Visual abnormalities
• Postmarketing reports: Miosis

Other

• Very common (10% or more): Pain (up to 26%), withdrawal syndrome (up to 24%), infection (up to 22%), asthenia (up to 16%), drug withdrawal syndrome, tiredness
• Common (1% to 10%): Abscess, accidental injury, accidental overdose, asthenic conditions, chest pain, chills, contusion, decreased weight, ear pain, edema, fall, fatigue, fever, increased weight, injury, limb injury, malaise, neonatal drug withdrawal syndrome, peripheral edema, pyrexia, road traffic accident, viral infection, weight loss
• Uncommon (0.1% to 1%): Accidental injury (including fall), chills/cold, face edema, feeling cold, hypothermia, influenza-like illness, noncardiac chest pain, rigors, warmth, weariness
• Rare (0.01% to 0.1%): Withdrawal symptoms
• Very rare (less than 0.01%): Thoracic pain
• Frequency not reported: Drug ineffective, drug interactions, drug tolerance, weakness
• Postmarketing reports: Deaths, decreased weight, drug ineffective, drug interaction, drug misuse, drug withdrawal reactions, drug withdrawal syndrome, fatigue, fetal disorders, IV/intentional misuse, neonatal withdrawal syndrome, peripheral edema

Buprenorphine-naloxone sublingual tablets:

• Postmarketing reports: Peripheral edema

The most common adverse events reported were those related to withdrawal symptoms (e.g., abdominal pain, headache, pain, diarrhea, nausea, muscle aches, anxiety, sweating).

Asthenic conditions included muscle weakness, lethargy, fatigue, and malaise.

Accidental injury included fall.

Withdrawal symptoms included agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor, and gastrointestinal disorders.

During treatment of opioid use disorder, cases of drug withdrawal reactions consistent with insufficient drug dosing have been reported; cases often occurred at or after 2 weeks of treatment initiation and resolved upon dose increase.

In cases of IV or intentional misuse, local reactions (e.g., cellulitis, abscess) that were sometimes septic, potentially serious acute hepatitis, pneumonia, endocarditis, and other serious infections have been reported.

Psychiatric

• Very common (10% or more): Insomnia (up to 28%), anxiety (up to 14%), depression (up to 13%)
• Common (1% to 10%): Abnormal thinking, agitation, confusion, decreased libido, hallucinations, hostility, medical dependence, nervousness, paranoia
• Uncommon (0.1% to 1%): Abnormal dreaming, affect lability, aggression, apathy, confusional state, depersonalization, disorientation, dreaming, euphoria/euphoric mood, euphoric mood, euphoric mood/euphoria, nightmare, psychosis, psychotic disorder, restlessness, sleep disorder
• Rare (0.01% to 0.1%): Dysphoria, psychomimetic effects (e.g., hallucinations, anxiety, nightmares)
• Very rare (less than 0.01%): Dependence, mood swings
• Frequency not reported: Confusional state/confusion, depressed mood, drug dependence, mental status changes, psychotic disorder/psychosis
• Postmarketing reports: Confusional state, drug abuse, drug dependence, hallucinations, neonatal feeding disorder

Renal

• Uncommon (0.1% to 1%): Increased blood creatinine, nephrolithiasis

Respiratory

• Very common (10% or more): Rhinitis (up to 15%), influenza syndrome (up to 10.2%)
• Common (1% to 10%): Asthma, bronchitis, cough, dyspnea, hypoventilation, increased cough, influenza, nasal congestion, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngolaryngeal pain, pneumonia, sinus congestion, sinusitis, upper respiratory tract infection, yawning
• Uncommon (0.1% to 1%): Apnea, asthma aggravated, hiccups, hyperventilation, hypoxia, respiratory depression, wheezing
• Rare (0.01% to 0.1%): Respiratory failure
• Frequency not reported: Abnormal respiration, acute sinusitis, bronchospasm, respiratory distress, rhinorrhea
• Postmarketing reports: Asphyxia, bronchospasm, hypoventilation, respiratory depression

Opioids:

• Frequency not reported: Respiratory depression, sleep-related breathing disorders (including central sleep apnea, sleep-related hypoxemia)

Serious, life-threatening, or fatal respiratory depression has been reported with opioid use, even when used as recommended.

Frequently asked questions

• Can you take Subutex with opioids in your system?
• Subutex vs Suboxone: What's the difference between them?
• How long does Subutex stay in your system?
• What are the different brands of buprenorphine?
• Why was Subutex discontinued?
• What happens if you swallow Subutex?
• How long do you keep Subutex under your tongue?
• Does it make you sleepy?
• Round white pill with 8 on one side and an arrow on the other side. Is it Subutex 8 mg?

Further information

Subutex side effects can vary depending on the individual. 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.

Medical Disclaimer