The following serious adverse reactions are described, or described in greater detail, in other sections:
The following adverse reactions associated with the use of hydromorphone were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.
The most common adverse effects are light-headedness, 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
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Hydromorphone Hydrochloride Injection.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
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