Naldebain Adverse Reactions

Because clinical studies 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 studies of another drug and may not reflect the rates observed in practice.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials: A total of 109 subjects received single dose of 150 mg NALDEBAIN were included in the population for safety evaluation of NALDEBAIN.
Overall evaluation of the safety profile in clinical studies, the most clinically significant adverse reactions observed with NALDEBAIN 150 mg were nausea, vomiting, injection site reaction, pyrexia and dizziness. All those reactions are assessed as mild to moderate in severity. The incidence of adverse reactions is listed in Table 3. (See Table 3.)

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Most of the subjects in phase III studies with injection site reaction were recovered present at final visit (Day 7-10). In a bioavailability study, the study period after NALDEBAIN administration is 14 days. The injection site reaction is monitored until end of the study. Part of subjects recovered on Day 8, and all subjects recovered on Day 12. All the subjects felt the symptoms is tolerable and finished the study. The observation is all the injection site reaction recovered at the end of the study. That means the reaction is tolerable and reversible.
Overall evaluation of the safety profile in clinical studies, the frequency of adverse events whether drug related or not in NALDEBAIN and placebo treatment groups is summarized in Table 4. (See Table 4.)

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Postmarketing Experience: Serotonin syndrome (see Precautions); Adrenal insufficiency (see Precautions).
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids. Chronic use of opioids may influence the hypothalamic pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies concluded to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
Infertility: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.