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Suboxone (Buprenorphine Hydrochloride / Naloxone Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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).

Table 3. Adverse Events (≥5%) by Body System and Treatment Group in a 4-week Study
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
Asthenia7 (6.5%)5 (4.9%)7 (6.5%)
Chills8 (7.5%)8 (7.8%)8 (7.5%)
Headache39 (36.4%)30(29.1%)24 (22.4%)
Infection6 (5.6%)12(11.7%)7 (6.5%)
Pain24 (22.4%)19(18.4%)20(18.7%)
Pain Abdomen12(11.2%)12(11.7%)7 (6.5%)
Pain Back4 (3.7%)8 (7.8%)12(11.2%)
Withdrawal Syndrome27 (25.2%)19(18.4%)40 (37.4%)
Cardiovascular System
Vasodilation10(9.3%)4 (3.9%)7 (6.5%)
Digestive System
Constipation13(12.1%)8 (7.8%)3 (2.8%)
Diarrhea4 (3.7%)5 (4.9%)16(15.0%)
Nausea16(15.0%)14(13.6%)12(11.2%)
Vomiting8 (7.5%)8 (7.8%)5 (4.7%)
Nervous System
Insomnia15(14.0%)22(21.4%)17(15.9%)
Respiratory System
Rhinitis5 (4.7%)10(9.7%)14(13.1%)
Skin And Appendages
Sweating15(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.

Table 4. 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) 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:
"Very low" dose (1 mg solution) would be less than a tablet dose of 2 mg
"Low" dose (4mg solution) approximates a 6 mg tablet dose
"Moderate" dose (8mg solution) approximates a 12 mg tablet dose
"High" dose (16mg solution) approximates a 24 mg tablet dose

Body as a Whole
Abscess9 (5%)2(1%)3 (2%)2(1%)16(2%)
Asthenia26(14%)28(16%)26(14%)24(13%)104(14%)
Chills11 (6%)12(7%)9 (5%)10(6%)42 (6%)
Fever7 (4%)2(1%)2(1%)10(6%)21 (3%)
Flu Syndrome.4 (2%)13(7%)19(10%)8 (4%)44 (6%)
Headache51 (28%)62 (34%)54 (29%)53 (29%)220 (30%)
Infection32(17%)39 (22%)38 (20%)40 (22%)149 (20%)
Injury Accidental5 (3%)10(6%)5 (3%)5 (3%)25 (3%)
Pain47 (26%)37(21%)49 (26%)44 (24%)177 (24%)
Pain Back18(10%)29(16%)28(15%)27 (15%)102(14%)
Withdrawal Syndrome45 (24%)40 (22%)41 (22%)36 (20%)162(22%)
Digestive System
Constipation10(5%)23(13%)23(12%)26(14%)82(11%)
Diarrhea19(10%)8 (4%)9 (5%)4 (2%)40 (5%)
Dyspepsia6 (3%)10(6%)4 (2%)4 (2%)24 (3%)
Nausea12 (7%)22(12%)23(12%)18(10%)75(10%)
Vomiting8 (4%)6 (3%)10(5%)14 (8%)38 (5%)
Nervous System
Anxiety22(12%)24(13%)20(11%)25(14%)91 (12%)
Depression24(13%)16(9%)25(13%)18(10%)83(11%)
Dizziness4 (2%)9 (5%)7 (4%)11 (6%)31 (4%)
Insomnia42 (23%)50 (28%)43 (23%)51 (28%)186(25%)
Nervousness12 (7%)11 (6%)10(5%)13 (7%)46 (6%)
Somnolence5 (3%)13(7%)9 (5%)11 (6%)38 (5%)
Respiratory System
Cough Increase5 (3%) 1 1 (6%)6 (3%)4 (2%)26 (4%)
Pharyngitis6 (3%)7 (4%)6 (3%)9 (5%)28 (4%)
Rhinitis27(15%)16(9%)1 5 (8%)21 (12%)79(11%)
Skin And Appendages
Sweat23 (13%)21 (12%)20(11%)23(13%)87(12%)
Special Senses
Runny Eyes13(7%)9 (5%)6 (3%)6 (3%)34 (5%)



REPORTS OF SUSPECTED SUBOXONE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Suboxone. The information is not vetted and should not be considered as verified clinical evidence.

Possible Suboxone side effects / adverse reactions in 33 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 33 year old female

Reactions: Hypersensitivity, Urinary Incontinence, Faecal Incontinence, Mental Disorder, Disturbance in Attention, Amnesia

Adverse event resulted in: hospitalization

Suspect drug(s):
Klonopin
    Dosage: unknown dosing details
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: suboxone sublingual film. dosage unknown.
    Indication: Product Used FOR Unknown Indication



Possible Suboxone side effects / adverse reactions in 61 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 61 year old male

Reactions: Hepatic Neoplasm Malignant, Feeling of Body Temperature Change, Hyperhidrosis

Suspect drug(s):
Suboxone
    Dosage: sublingual film - dosing information unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Dosage: sublingual film - dosing information unknown



Possible Suboxone side effects / adverse reactions in 27 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 27 year old female

Reactions: Diarrhoea, Memory Impairment, Asthenia, Convulsion

Suspect drug(s):
Suboxone



See index of all Suboxone side effect reports >>

Drug label data at the top of this Page last updated: 2005-12-15

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