Most common (>=5%) Somnolence or sedation, pyrexia, upper respiratory tract infection, lethargy, drooling, aggression, vomiting, irritability, insomnia, fatigue, cough
Serious Serious dermatological reactions, DRESS/multiorgan hypersensitivity, respiratory depression with opioids, dependence and withdrawal reactions, suicidal behavior and ideation, neonatal sedation and withdrawal syndrome
Postmarketing Anemia, eosinophilia, leukopenia, thrombocytopenia, diplopia, blurred vision, abdominal distention, hypothermia, elevated hepatic enzymes, muscle spasms, agitation, anxiety, confusional state, depression, hallucination, urinary retention, respiratory depression, rash, urticaria, angioedema