Suboxone Side Effects
Please note - some side effects for Suboxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Suboxone - for the Consumer
Suboxone
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Suboxone:
Seek medical attention right away if any of these SEVERE side effects occur when using Suboxone:Chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; sleeplessness; stomach pain; sweating; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; blurred vision; confusion; dark urine; decreased attention; fainting; irregular heartbeat; loss of appetite; loss of coordination; mental or mood changes (eg, depression); pale stools; persistent trouble sleeping; severe or persistent dizziness or drowsiness; severe or persistent stomach pain or constipation; slow or shallow breathing; slowed reflexes; slurred speech; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Suboxone Film
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Suboxone Film:
Seek medical attention right away if any of these SEVERE side effects occur when using Suboxone Film:Back pain; burning, numbness, pain, redness, or tingling of the mouth or tongue; chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; stomach pain; sweating; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; blurred vision; confusion; dark urine; decreased attention; fainting; irregular heartbeat; loss of appetite; loss of coordination; mental or mood changes (eg, depression); pale stools; persistent trouble sleeping; severe or persistent dizziness or drowsiness; severe or persistent stomach pain; slow or shallow breathing; slowed reflexes; slurred speech; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopSuboxone Side Effects - for the Professional
Suboxone
The safety of Suboxone has been evaluated in 497 opioid-dependent subjects. The prospective evaluation of Suboxone was supported by clinical trials using SUBUTEX (buprenorphine tablets without naloxone) and other trials using buprenorphine sublingual solutions. In total, safety data are available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.
Few differences in adverse event profile were noted between Suboxone and SUBUTEX or buprenorphine administered as a sublingual solution.
In a comparative study, adverse event profiles were similar for subjects treated with 16 mg Suboxone or 16mg SUBUTEX. The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 3).
| N(%) | N(%) | N(%) | |
|---|---|---|---|
| Body System / Adverse Event (COSTART Terminology) | Suboxone 16mg/day N=107 |
SUBUTEX 16mg/day N=103 | Placebo N=107 |
| Body as a Whole | |||
| Asthenia | 7 (6.5%) | 5 (4.9%) | 7 (6.5%) |
| Chills | 8 (7.5%) | 8 (7.8%) | 8 (7.5%) |
| Headache | 39 (36.4%) | 30(29.1%) | 24 (22.4%) |
| Infection | 6 (5.6%) | 12(11.7%) | 7 (6.5%) |
| Pain | 24 (22.4%) | 19(18.4%) | 20(18.7%) |
| Pain Abdomen | 12(11.2%) | 12(11.7%) | 7 (6.5%) |
| Pain Back | 4 (3.7%) | 8 (7.8%) | 12(11.2%) |
| Withdrawal Syndrome | 27 (25.2%) | 19(18.4%) | 40 (37.4%) |
| Cardiovascular System | |||
| Vasodilation | 10(9.3%) | 4 (3.9%) | 7 (6.5%) |
| Digestive System | |||
| Constipation | 13(12.1%) | 8 (7.8%) | 3 (2.8%) |
| Diarrhea | 4 (3.7%) | 5 (4.9%) | 16(15.0%) |
| Nausea | 16(15.0%) | 14(13.6%) | 12(11.2%) |
| Vomiting | 8 (7.5%) | 8 (7.8%) | 5 (4.7%) |
| Nervous System | |||
| Insomnia | 15(14.0%) | 22(21.4%) | 17(15.9%) |
| Respiratory System | |||
| Rhinitis | 5 (4.7%) | 10(9.7%) | 14(13.1%) |
| Skin And Appendages | |||
| Sweating | 15(14.0%) | 13(12.6%) | 11 (10.3%) |
The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 4 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.
| Body System /Adverse Event (COSTART Terminology) | Buprenorphine Dose* | ||||
| Very Low* (N=184) | Low* (N=180) | Moderate* (N=186) | High* (N=181) | Total* (N=731) | |
| N (%) | N (%) | N (%) | N (%) | N (%) | |
|
*Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes: |
|||||
| Body as a Whole | |||||
| Abscess | 9 (5%) | 2(1%) | 3 (2%) | 2(1%) | 16(2%) |
| Asthenia | 26(14%) | 28(16%) | 26(14%) | 24(13%) | 104(14%) |
| Chills | 11 (6%) | 12(7%) | 9 (5%) | 10(6%) | 42 (6%) |
| Fever | 7 (4%) | 2(1%) | 2(1%) | 10(6%) | 21 (3%) |
| Flu Syndrome. | 4 (2%) | 13(7%) | 19(10%) | 8 (4%) | 44 (6%) |
| Headache | 51 (28%) | 62 (34%) | 54 (29%) | 53 (29%) | 220 (30%) |
| Infection | 32(17%) | 39 (22%) | 38 (20%) | 40 (22%) | 149 (20%) |
| Injury Accidental | 5 (3%) | 10(6%) | 5 (3%) | 5 (3%) | 25 (3%) |
| Pain | 47 (26%) | 37(21%) | 49 (26%) | 44 (24%) | 177 (24%) |
| Pain Back | 18(10%) | 29(16%) | 28(15%) | 27 (15%) | 102(14%) |
| Withdrawal Syndrome | 45 (24%) | 40 (22%) | 41 (22%) | 36 (20%) | 162(22%) |
| Digestive System | |||||
| Constipation | 10(5%) | 23(13%) | 23(12%) | 26(14%) | 82(11%) |
| Diarrhea | 19(10%) | 8 (4%) | 9 (5%) | 4 (2%) | 40 (5%) |
| Dyspepsia | 6 (3%) | 10(6%) | 4 (2%) | 4 (2%) | 24 (3%) |
| Nausea | 12 (7%) | 22(12%) | 23(12%) | 18(10%) | 75(10%) |
| Vomiting | 8 (4%) | 6 (3%) | 10(5%) | 14 (8%) | 38 (5%) |
| Nervous System | |||||
| Anxiety | 22(12%) | 24(13%) | 20(11%) | 25(14%) | 91 (12%) |
| Depression | 24(13%) | 16(9%) | 25(13%) | 18(10%) | 83(11%) |
| Dizziness | 4 (2%) | 9 (5%) | 7 (4%) | 11 (6%) | 31 (4%) |
| Insomnia | 42 (23%) | 50 (28%) | 43 (23%) | 51 (28%) | 186(25%) |
| Nervousness | 12 (7%) | 11 (6%) | 10(5%) | 13 (7%) | 46 (6%) |
| Somnolence | 5 (3%) | 13(7%) | 9 (5%) | 11 (6%) | 38 (5%) |
| Respiratory System | |||||
| Cough Increase | 5 (3%) | 11 (6%) | 6 (3%) | 4 (2%) | 26 (4%) |
| Pharyngitis | 6 (3%) | 7 (4%) | 6 (3%) | 9 (5%) | 28 (4%) |
| Rhinitis | 27(15%) | 16(9%) | 1 5 (8%) | 21 (12%) | 79(11%) |
| Skin And Appendages | |||||
| Sweat | 23 (13%) | 21 (12%) | 20(11%) | 23(13%) | 87(12%) |
| Special Senses | |||||
| Runny Eyes | 13(7%) | 9 (5%) | 6 (3%) | 6 (3%) | 34 (5%) |
Side Effects by Body System - for Healthcare Professionals
General
Side effects affecting the body as a whole in opioid dependent patients have included asthenia (6.5% vs 6.5% with placebo), chills (7.5% vs 7.5% with placebo), headache (36.4% vs 22.4% with placebo), infection (5.6% vs 6.5% with placebo), pain (22.4% vs 18.7% with placebo), abdominal pain (11.2% vs 6.5% with placebo), back pain (3.7% vs 11.2% with placebo), and withdrawal syndrome (25.2% vs 37.4% with placebo).
Chronic administration of buprenorphine may result in dependence and withdrawal symptoms may occur upon abrupt withdrawal. The naloxone component may produce severe withdrawal symptoms if buprenorphine-naloxone is injected by opioid-dependent individuals. Sublingual buprenorphine-naloxone may also cause withdrawal symptoms if taken before the opioid agonist effects have subsided.
Other
Neonatal withdrawal has been reported in infants of women who took buprenorphine during pregnancy.
Nervous system
Nervous system side effects in opioid dependent patients have included insomnia (14% vs 15.9% with placebo). Increased CNS depression may occur in patients receiving concurrent CNS depressants (e.g., narcotic analgesics, general anesthetics, benzodiazepines, phenothiazines, tranquilizers, sedative/hypnotics, or alcohol). Buprenorphine may elevate cerebrospinal fluid pressure. Side effects associated with buprenorphine alone have included anxiety, depression, dizziness, insomnia, nervousness, and somnolence.
Respiratory
Respiratory system side effects in opioid dependent patients have included rhinitis (4.7% vs 13.1% with placebo).
Respiratory depression has been associated with buprenorphine, particularly after intravenous administration. Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants.
Gastrointestinal
Gastrointestinal side effects in opioid dependent patients have included constipation (12.1% vs 2.8% with placebo), diarrhea (3.7% vs 15% with placebo), nausea (15% vs 11.2% with placebo), and vomiting (7.5% vs 4.7% with placebo). Buprenorphine may increase intracholedochal pressure.
Endocrine
Endocrine effects in opioid dependent patients have included sweating (14% vs 10.3% with placebo).
Hypersensitivity
Hypersensitivity reactions associated with buprenorphine have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.
Cardiovascular
Misuse of crushed buprenorphine tablets by inhalation has been associated with chest pain and acute anterior myocardial infarction in a 22-year-old male.
Cardiovascular side effects in opioid dependent patients have included vasodilation (9.3% vs 6.5% with placebo). Buprenorphine may cause orthostatic hypotension.
Ocular
Ocular side effects associated with buprenorphine may include miosis.
Hepatic
Hepatic side effects associated with sublingual buprenorphine have included cytolytic hepatitis and hepatitis with jaundice in opioid addicts. Preexisting liver dysfunction, hepatitis B or C virus infection, injectable drug use, or concomitant hepatotoxic drugs may have had contributory roles. Baseline and periodic monitoring of liver function tests is recommended during therapy. Close monitoring or careful discontinuation is recommended if a hepatic adverse reaction is suspected.
Psychiatric
Auditory and visual hallucinations have been associated with parenteral and sublingual buprenorphine.
TopMore Suboxone resources
- Suboxone Prescribing Information (FDA)
- Suboxone Advanced Consumer (Micromedex) - Includes Dosage Information
- Suboxone MedFacts Consumer Leaflet (Wolters Kluwer)
- Suboxone Consumer Overview
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