Sublocade 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 Sublocade.
Applies to buprenorphine: transdermal patch extended release. Other dosage forms:
Warning
Transdermal route (Patch, Extended Release)
Addiction, Abuse, and MisuseBuprenorphine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing buprenorphine, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of buprenorphine. Monitor for respiratory depression, especially during initiation of buprenorphine or following a dose increase. Misuse or abuse of buprenorphine by chewing, swallowing, snorting, or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.Accidental ExposureAccidental exposure to even one dose of buprenorphine, especially in children, can result in a fatal overdose of buprenorphine.Neonatal Opioid Withdrawal SyndromeProlonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of buprenorphine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Follow patients for signs and symptoms of respiratory depression and sedation
Serious side effects of Sublocade
Along with its needed effects, buprenorphine (the active ingredient contained in Sublocade) 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:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- swelling, burn, or blisters at the patch site
- tingling of the hands or feet
- unusual weight loss
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- cough producing mucus
- diarrhea
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with moving
- dizziness
- ear congestion
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- increased sweating
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- muscle stiffness
- nasal congestion
- nausea
- nervousness
- pain
- pain in the arms or legs
- pounding in the ears
- runny nose
- shakiness in the legs, arms, hands, or feet
- shivering
- slow or fast heartbeat
- sneezing
- sore throat
- sweating
- trembling or shaking of the hands or feet
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Rare
- Arm, back, or jaw pain
- blistering, burning, crusting, dryness, or flaking of the skin
- blue lips, fingernails, or skin
- chest heaviness
- confusion
- decreased urination
- deep or fast breathing with dizziness
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- extremely shallow or slow breathing
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- increase in heart rate
- irregular, fast or slow, or shallow breathing
- itching, scaling, severe redness, soreness, or swelling of the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of bladder control
- loss of consciousness
- numbness of the feet, hands, and around the mouth
- rapid breathing
- slow or irregular heartbeat
- stomach pain or tenderness
- sunken eyes
- swelling or puffiness of the face
- thirst
- trouble with walking
- wrinkled skin
Incidence not known
- Agitation
- darkening of the skin
- skin rash
- mental depression
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- restlessness
- talking or acting with excitement you cannot control
- twitching
Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine:
Symptoms of overdose
- Blurred vision
- confusion
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint (small) pupils in the eyes
- relaxed and calm
- sleepiness or unusual drowsiness
- sweating
- unusual tiredness or weakness
Other side effects of Sublocade
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
- Constipation
- itching, redness, or rash at the patch site
Less common
- Acid or sour stomach
- anxiety
- back pain
- belching
- depression
- headache, severe and throbbing
- heartburn
- indigestion
- irritation at the patch site
- itching skin or rash
- lack or loss of strength
- muscle spasms
- neck pain
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, or pain
- swelling of the joints
- upper abdominal or stomach pain
- weight loss
Rare
- Being forgetful
- blurred or loss of vision
- change in taste
- changes in patterns and rhythms of speech
- clumsiness or unsteadiness
- confusion about identity, place, and time
- cramps
- decreased interest in sexual intercourse
- decreased weight
- disturbed color perception
- double vision
- dry eyes or skin
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- feeling of unreality
- full feeling
- general feeling of discomfort or illness
- halos around lights
- heavy bleeding
- inability to have or keep an erection
- lack of feeling or emotion
- loss in sexual ability, desire, drive, or performance
- loss of taste
- muscle weakness
- night blindness
- nightmares
- overbright appearance of lights
- passing gas
- pressure in the stomach
- relaxed and calm
- restlessness
- sensation of spinning
- sense of detachment from self or body
- sleepiness
- slurred speech
- swelling of the stomach area
- trouble with speaking
- tunnel vision
- uncaring
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
QT prolongation has been observed. In clinical trials of buprenorphine (the active ingredient contained in Sublocade) 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]
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
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]
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
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]
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]
Frequently asked questions
- What are the different brands of buprenorphine?
- What is the difference between Sublocade and Brixadi?
- How and where is the Sublocade injection given?
- Is Sublocade covered by Medicaid?
- Is Probuphine better than Sublocade?
- Who makes Sublocade in the U.S?
- Is Sublocade a controlled substance?
- How is Sublocade administered?
- Sublocade vs Suboxone - What's the difference between them?
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References
1. Product Information. Subutex (buprenorphine). Reckitt and Colman Pharmaceuticals Inc. 2002.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
4. Product Information. Butrans (buprenorphine). Purdue Pharma LP. 2010.
5. Product Information. Sublocade (buprenorphine). Reckitt Benckiser Pharmaceuticals Inc. 2018.
6. Product Information. Buprenex (buprenorphine). Reckitt and Colman Pharmaceuticals Inc. 2001;PROD.
7. Product Information. Probuphine (buprenorphine). Braeburn Pharmaceuticals. 2016.
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.