Subutex Side Effects
Generic name: buprenorphine
Note: This document contains side effect information about buprenorphine. Some dosage forms listed on this page may not apply to the brand name Subutex.
Applies to buprenorphine: intradermal implant. Other dosage forms:
Warning
Intradermal route (Implant)
Insertion and removal of the buprenorphine implant are associated with the risk of implant migration, protrusion, and expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. Because of the risks associated with insertion and removal, the buprenorphine implant is available only through a restricted program called the PROBUPHINE REMS Program. All healthcare providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing buprenorphine implants.
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:
Less common
- Chest pain
- dizziness
- headache, severe and throbbing
- lack or loss of strength
- sleepiness or unusual drowsiness
Incidence not known
- Agitation
- bleeding, itching, pain, redness, scarring, or swelling at the incision
- chest tightness
- confusion
- cough
- dark urine
- darkening of the skin
- diarrhea
- difficult or trouble breathing
- difficulty with swallowing
- fainting
- fast heartbeat
- fever
- general tiredness and weakness
- hives, itching, or skin rash
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- mental depression
- noisy breathing
- overactive reflexes
- pale or blue lips, fingernails, or skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine:
Symptoms of overdose
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm
- sleepiness
- sweating
- unusual tiredness or weakness
Other 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:
More common
- Back pain
- depression
- difficulty having a bowel movement (stool)
- headache
- mouth pain
- nausea
- sneezing
- stuffy or runny nose
- toothache
- vomiting
Less common
- Bloated
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- excess air or gas in stomach or intestines
- full feeling
- pain in the arms or legs
- passing gas
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%): 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]
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]
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]
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]
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]
Hematologic
Common (1% to 10%): Lymphadenopathy
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]
Hypersensitivity
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]
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]
Metabolic
Common (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Dehydration, loss of appetite, weight decreased
Postmarketing reports: Neonatal feeding disorder[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]
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]
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]
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]
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]
Frequently asked questions
- Can you take Subutex with opioids in your system?
- How long does Subutex stay in your system?
- Subutex vs Suboxone: What's the difference between them?
- 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?
More about Subutex (buprenorphine)
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References
1. (2001) "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc
2. (2002) "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
5. (2010) "Product Information. Butrans (buprenorphine)." Purdue Pharma LP
6. (2016) "Product Information. Probuphine (buprenorphine)." Braeburn Pharmaceuticals
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.