Because clinical trials 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 trials of another drug and may not reflect the rates observed in clinical practice.
Serious adverse reactions associated with DILAUDID INJECTION and DILAUDID-HP INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The following serious adverse reactions described elsewhere in the labeling include:
- Respiratory depression and secondary effects on intracranial pressure [see WARNINGS AND PRECAUTIONS]
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal effects and effects in sphincter of Oddi [see WARNINGS AND PRECAUTIONS]
- Drug abuse, addiction, and dependence [see Drug Abuse And Dependence]
- Effects on the ability to drive and operate machinery [see WARNINGS AND PRECAUTIONS]
The most common 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
Cardiac disorders: tachycardia, bradycardia, palpitations
Eye disorders: vision blurred, diplopia, miosis, visual impairment
Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain
General disorders and administration site conditions: weakness, feeling abnormal, chills, injection site urticaria
Hepatobiliary disorders: biliary colic
Metabolism and nutrition disorders: decreased appetite
Musculoskeletal and connective tissue disorders: muscle rigidity
Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope
Psychiatric disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams
Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects
Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm
Skin and subcutaneous tissue disorders: injection site pain, urticaria, rash, hyperhidrosis
Vascular disorders: flushing, hypotension, hypertension
The following adverse reactions have been identified during post-approval use of hydromorphone. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylactic reactions, confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, injection site reactions, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.