ADVERSE REACTIONS
The major hazards of DILAUDID-HP include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.
The most frequently observed adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.
Less Frequently Observed Adverse Reactions
General and CNS
Weakness, headache, agitation, tremor, uncoordinated muscle movements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure
Cardiovascular
Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension
Respiratory
Bronchospasm and laryngospasm
Gastrointestinal
Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alterations
Genitourinary
Urinary retention or hesitancy, antidiuretic effects
Dermatologic
Urticaria, other skin rashes, wheal and flare over the vein with intravenous injection, diaphoresis
Other
In clinical trials, neither local tissue irritation nor induration was observed at the site of subcutaneous injection of DILAUDID-HP; pain at the injection site was rarely observed. However, local irritation and induration have been seen following parenteral injection of other opioid drug products.
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