ADVERSE REACTIONS
NOTE: THE SUSTAINED RELEASE OF MORPHINE FROM ORAMORPH SR SHOULD BE TAKEN INTO CONSIDERATION IN THE EVENT OF OCCURRING ADVERSE REACTIONS. |
Adverse reactions caused by morphine are essentially those observed with other opioid analgesics. They include the following major hazards: respiratory depression, and less frequently, circulatory depression, apnea, shock and cardiac arrest secondary to respiratory and/or circulatory depression.
Most Frequently Observed Reactions:
Constipation, nausea, vomiting, lightheadedness, dizziness, sedation, dysphoria, euphoria, and sweating. Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Some adverse reactions in ambulatory patients may be alleviated if the patient is in a supine position.
Less Frequently Observed Reactions:
Body as a Whole: Edema, antidiuretic effect, chills, muscle tremor, muscle rigidity.
Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.
Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alterations.
Genitourinary: Urine retention or hesitance, reduced libido and/or potency.
Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, paresthesia, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, transient hallucination and disorientation, visual disturbances, insomnia, increased intracranial pressure.
Skin: Pruritus, urticaria and other skin rashes.
Special Senses: Blurred vision, nystagmus, diplopia, miosis.
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REPORTS OF SUSPECTED ORAMORPH SR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Oramorph SR. The information is not vetted and should not be considered as verified clinical evidence.
Possible Oramorph SR side effects / adverse reactions in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-10-10
Patient: 70 year old female
Reactions: Acute Generalised Exanthematous Pustulosis, Toxic Epidermal Necrolysis, Pyrexia
Adverse event resulted in: hospitalization
Suspect drug(s):
Oramorph SR
Other drugs received by patient: Corticosteroids
Possible Oramorph SR side effects / adverse reactions in 65 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-17
Patient: 65 year old male weighing 51.0 kg (112.2 pounds)
Reactions: Abdominal Pain, Cardio-Respiratory Arrest
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Oramorph SR
Dosage: 10 mg, 3x/day
Oramorph SR
Dosage: 15 mg, 3x/day
Naloxone/oxycodone
Dosage: 5 mg, 3x/day
Lyrica
Dosage: 150 mg, 2x/day
Indication: Abdominal Pain
Start date: 2008-01-01
Lyrica
Dosage: 300 mg, 2x/day
Fentanyl-100
Dosage: 25ug, once every 3 days
Acetaminophen
Dosage: 1 g, 3x/day
Tramadol HCL
Dosage: 100 mg, 3x/day
Possible Oramorph SR side effects / adverse reactions in 65 year old male
Reported by a physician from United Kingdom on 2011-11-18
Patient: 65 year old male weighing 51.0 kg (112.2 pounds)
Reactions: Abdominal Pain, Cardio-Respiratory Arrest
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Oramorph SR
Fentanyl-100
Dosage: patch changed every 3 days
Oramorph SR
Acetaminophen
Lyrica
Indication: Abdominal Pain
Start date: 2008-01-01
Lyrica
Tramadol HCL
Naloxone HCL
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