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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REPORTS OF SUSPECTED DILAUDID-HP SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Dilaudid-HP. The information is not vetted and should not be considered as verified clinical evidence.
Possible Dilaudid-HP side effects / adverse reactions in 58 year old female
Reported by a consumer/non-health professional from United States on 2011-12-22
Patient: 58 year old female
Reactions: Cardiac Discomfort
Suspect drug(s):
Dilaudid-HP
Possible Dilaudid-HP side effects / adverse reactions in 64 year old female
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: 64 year old female
Reactions: Drug Hypersensitivity, Amnesia
Adverse event resulted in: disablity
Suspect drug(s):
Dilaudid-HP
Possible Dilaudid-HP side effects / adverse reactions in 49 year old male
Reported by a physician from United States on 2012-07-16
Patient: 49 year old male
Reactions: Burning Sensation, Back Pain, Drug Tolerance, Pain, Intervertebral Disc Degeneration, Gait Disturbance, Abscess, Muscle Spasms
Adverse event resulted in: hospitalization
Suspect drug(s):
Dilaudid-HP
Dosage: 1 mg, prn
Indication: Back Pain
Dilaudid-HP
Dosage: 0.4 mg/hr, unk
Lyrica
Dosage: 150 mg, see text
Indication: Product Used FOR Unknown Indication
Start date: 2010-07-01
Oxycodone HCL
Dosage: 20 mg, q4h
Administration route: Oral
Indication: Back Pain
Oxycodone HCL
Dosage: 30 mg, q4h
Administration route: Oral
Oxycontin
Dosage: 160 mg, tid
Administration route: Oral
Indication: Back Pain
Start date: 2010-06-30
Oxycontin
Dosage: 80 mg, see text
Administration route: Oral
Start date: 2010-07-01
Oxycontin
Dosage: 60 mg, see text
Start date: 2010-07-01
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