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Suboxone

Last reviewed on RxList: 2/12/2018
Suboxone Side Effects Center
Prescription Drug Abuse: Statistics, Facts, and Symptoms

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/12/2018

Suboxone (buprenorphine and naloxone) is a combination of two opioid receptor antagonists used in the maintenance treatment of opioid addiction. Side effects of Suboxone include:

  • mouth numbness,
  • mouth redness,
  • mouth pain,
  • headache,
  • dizziness,
  • numbness or tingling,
  • drowsiness,
  • sleep problems (insomnia),
  • stomach pain,
  • vomiting,
  • constipation,
  • feeling drunk, or
  • trouble concentrating.

Get medical help right away if you have serious side effects of Suboxone including:

  • fainting,
  • fast or irregular heartbeat,
  • severe dizziness,
  • mental/mood changes (such as agitation, confusion, hallucinations),
  • slow or shallow breathing,
  • unusual drowsiness, or
  • difficulty waking up.

It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Suboxone may interact with other drugs including benzodiazepines, erythromycin, rifampin, and HIV protease inhibitors. Buprenorphine and naloxone may dangerously increase the effects of other drugs that cause drowsiness. Neonatal withdrawal has been reported in the infants of women treated with buprenorphine during pregnancy. Breastfeeding is not advised in mothers treated with buprenorphine products as it is known to pass into breast milk.

Our Suboxone Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Suboxone Consumer Information
Prescription Drug Abuse: Statistics, Facts, and Symptoms

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once or seek emergency medical attention if you have:

  • extreme drowsiness;
  • loss of coordination, weakness or limp feeling;
  • blurred vision, slurred speech, thinking problems;
  • weak or shallow breathing;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pounding heartbeats or fluttering in your chest; or
  • withdrawal symptoms--diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

Common side effects may include:

  • headache, mild dizziness;
  • numbness or tingling;
  • drowsiness, or sleep problems (insomnia);
  • stomach pain, vomiting, constipation;
  • redness, pain, or numbness in your mouth;
  • feeling drunk; or
  • trouble concentrating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Suboxone (Buprenorphine HCl and naloxone HCl)

Suboxone Professional Information
Prescription Drug Abuse: Statistics, Facts, and Symptoms

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUBOXONE sublingual tablet was evaluated in 497 opioid-dependent subjects. The prospective evaluation of SUBOXONE sublingual tablet was supported by clinical trials using SUBUTEX (buprenorphine tablets without naloxone) and other trials using buprenorphine sublingual solutions. In total, safety data were 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.

The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1).

Table 1: Adverse Events ≥ 5% by Body System and Treatment Group in a 4-week Study

Body System / Adverse Event (COSTART Terminology) N (%) SUBOXONE sublingual tablets 16 mg/day
N=107
N (%) Placebo
N=107
Body as a Whole
Asthenia 7 (6.5%) 7 (6.5%)
Chills 8 (7.5%) 8 (7.5%)
Headache 39 (36.4%) 24 (22.4%)
Infection 6 (5.6%) 7 (6.5%)
Pain 24 (22.4%) 20 (18.7%)
Pain Abdomen 12 (11.2%) 7 (6.5%)
Pain Back 4 (3.7%) 12 (11.2%)
Withdrawal Syndrome 27 (25.2%) 40 (37.4%)
Cardiovascular System
Vasodilation 10 (9.3%) 7 (6.5%)
Digestive System
Constipation 13(12.1%) 3 (2.8%)
Diarrhea 4 (3.7%) 16 (15.0%)
Nausea 16 (15.0%) 12 (11.2%)
Vomiting 8 (7.5%) 5 (4.7%)
Nervous System
Insomnia 15 (14.0%) 17 (15.9%)
Respiratory System
Rhinitis 5 (4.7%) 14 (13.1%)
Skin and Appendages
Sweating 15 (14.0%) 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 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 2: Adverse Events (≥ 5%) by Body System and Treatment Group in a 16-week Study

Body System /Adverse Event (COSTART Terminology) Buprenorphine Dose*
Very Low*
(N=184) N (%)
Low*
(N=180) N (%)
Moderate*
(N=186) N (%)
High*
(N=181) N (%)
Total*
(N=731) N (%)
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%) 15 (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%)
*Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes:
“Very low” dose (1 mg solution) would be less than a tablet dose of 2 mg
“Low” dose (4 mg solution) approximates a 6 mg tablet dose
“Moderate” dose (8 mg solution) approximates a 12 mg tablet dose
“High” dose (16 mg solution) approximates a 24 mg tablet dose

Post-marketing Experience

The following adverse reactions have been identified during post approval use of buprenorphine/naloxone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported post-marketing adverse event not observed in clinical trials was peripheral edema.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in SUBOXONE sublingual tablet.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Local Reactions

Glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis.

Read the entire FDA prescribing information for Suboxone (Buprenorphine HCl and naloxone HCl)

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© Suboxone Patient Information is supplied by Cerner Multum, Inc. and Suboxone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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