BOXED WARNING SECTION WARNING: Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP by injection either alone or in combination with other substances. (See DRUG ABUSE AND DEPENDENCE section.)
ADVERSE REACTIONS SECTION Cardiovascular. Hypertension, hypotension, circulatory depression, tachycardia, syncope. Respiratory. Rarely, respiratory depression. Acute CNS Manifestations. Hallucinations (usually visual), disorientation, and confusion . Other CNS Effects. Grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, and depression; and rarely tremor, irritability, excitement, tinnitus. Autonomic. Sweating; infrequently flushing; and rarely chills. Gastrointestinal. Nausea, vomiting, constipation, diarrhea, anorexia, dry mouth, biliary tract spasm, and rarely abdominal distress. Allergic. Edema of the face; anaphylactic shock; dermatitis, including pruritus; flushed skin, including plethora; infrequently rash, and rarely urticaria. Ophthalmic. Visual blurring and focusing difficulty, miosis. Hematologic. Depression of white blood cells (especially granulocytes), with rare cases of agranulocytosis, which is usually reversible, moderate transient eosinophilia. Dependence and Withdrawal Symptoms. (See WARNINGS, PRECAUTIONS, and DRUG ABUSE AND DEPENDENCE Sections). Other. Urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome toxic epidermal necrolysis, and alterations in rate or strength of uterine contractions during labor.