The following adverse reactions were reported after administration of Buprenorphine (Transtec) in clinical studies and from postmarketing surveillance.
The frequencies are given as follows: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (≥1/10,000); Not known (cannot be estimated from the available data).
The most commonly reported systemic adverse reactions were nausea and vomiting.
The most commonly reported local adverse reactions were erythema and pruritus.
Immune system disorders:
Very rare: serious allergic reactions*.
Metabolism and nutrition disorders:
Rare: appetite lost.
Uncommon: confusion, sleep disorder, restlessness.
Rare: psychotomimetic effects (e.g. hallucinations, anxiety, nightmares), decreased libido.
Very rare: dependence, mood swings.
Nervous system disorders:
Common: dizziness, headache. Uncommon: sedation, somnolence. Rare: concentration impaired, speech disorder, numbness, dysequilibrium, paraesthesia (e.g. pricking or burning skin sensation). Very rare: muscle fasciculation, parageusia.
Rare: visual disturbance, blurring of vision, eyelid edema. Very rare: miosis.
Ear and labyrinth disorders:
Very rare: ear pain.
Uncommon: circulatory disorders (such as hypotension or, rarely, even circulatory collapse). Rare: hot flushes.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnea. Rare: respiratory depression. Very rare: hyperventilation, hiccups.
Very common: nausea. Common: vomiting, constipation. Uncommon: dry mouth. Rare: pyrosis. Very rare: retching.
Skin and subcutaneous tissue disorders:
Very common: erythema, pruritus. Common: exanthema, diaphoresis. Uncommon: rash. Rare: urticaria. Very rare: pustules, vesicles.
Renal and urinary disorders:
Uncommon: urinary retention, micturition disorders.
Reproductive system and breast disorders:
Rare: decreased erection.
General disorders and administration site conditions:
Common: edema, tiredness. Uncommon: weariness. Rare: withdrawal symptoms*, administration site reactions. Very rare: thoracic pain.
*In some cases, delayed allergic reactions occurred with marked signs of inflammation. In such cases, treatment with Buprenorphine (Transtec) should be terminated.
Buprenorphine has a low risk of dependence. After discontinuation of Buprenorphine (Transtec), withdrawal symptoms are unlikely. This is due to the very slow dissociation of buprenorphine from the opiate receptors and to the gradual decrease of buprenorphine serum concentrations (usually over a period of 30 hours after removal of the last transdermal patch). However, after long-term use of Buprenorphine (Transtec), withdrawal symptoms, similar to those occurring during opiate withdrawal, cannot be entirely excluded. These symptoms include: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.