Mild drowsiness. Sensitive patients may experience constipation and biliary dyskinesia. High doses of paracetamol may increase the activity of coumarin anticoagulant.
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
Codeine phosphate potentiates the effect of alcohol and other central depressive drugs. Other adverse reactions include allergic reaction, euphoria, dysphoria, abdominal pain and pruritus.
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 conducted 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.