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Buprenorphine (Buprenorphine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The safety of buprenorphine sublingual tablets has been evaluated in clinical trials using buprenorphine HCl sublingual tablets or buprenorphine sublingual solutions, and supported by other trials in 497 opioid-dependent subjects treated by buprenorphine and naloxone sublingual tablets. 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 buprenorphine and naloxone sublingual tablets and buprenorphine HCl sublingual tablets or buprenorphine administered as a sublingual solution.

In a comparative study, adverse event profiles were similar for subjects treated with 16 mg buprenorphine and naloxone sublingual tablets or 16 mg buprenorphine HCl sublingual tablets. 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) buprenorphine and naloxone sublingual tablets
16 mg/day
N=107
Buprenorphine HCl sublingual tablets
16 mg/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.

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 (%)
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:]

 



REPORTS OF SUSPECTED BUPRENORPHINE SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Buprenorphine side effects / adverse reactions in 88 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-04

Patient: 88 year old female

Reactions: Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Buprenorphine
    Dosage: unknown exact dosing details

Diazepam
    Dosage: unknown dosing details- takes as necessary
    Administration route: Oral
    Indication: Insomnia

Diazepam
    Dosage: unknown dosing details- takes as necessary
    Administration route: Oral
    Indication: Anxiety

Buprenorphine
    Dosage: dosage was 1/ 1 hours
    Indication: Pain

Other drugs received by patient: Mirtazapine; Cacichew D3; Atorvastatin; Omeprazole; Perindopril Erbumine; Prednisolone; Tolterodine Tartrate; Acetaminophen and Codeine Phosphate



Possible Buprenorphine side effects / adverse reactions in 22 year old female

Reported by a consumer/non-health professional from Sweden on 2011-10-05

Patient: 22 year old female

Reactions: Drug Interaction, Respiratory Arrest

Adverse event resulted in: death

Suspect drug(s):
Buprenorphine

Other drugs received by patient possibly interacting with the suspect drug:
Benzodiazepine Derivatives
    Indication: Product Used FOR Unknown Indication



Possible Buprenorphine side effects / adverse reactions in 37 year old female

Reported by a pharmacist from United Kingdom on 2011-10-05

Patient: 37 year old female

Reactions: Drug Ineffective, Maternal Exposure During Pregnancy, Stillbirth

Suspect drug(s):
Feverall
    Dosage: 1 gm
    Indication: Symphysiolysis

Buprenorphine
    Dosage: 10 mcg;qg;tder
    Indication: Symphysiolysis
    Start date: 2010-12-15
    End date: 2010-12-29

Acetaminophen W/ Codeine
    Dosage: po
    Administration route: Oral
    Indication: Symphysiolysis

MS Contin
    Dosage: 5 mg;bid;po
    Administration route: Oral
    Indication: Symphysiolysis
    Start date: 2010-09-22

Other drugs received by patient: Citalopram



See index of all Buprenorphine side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-24

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