Oramorph SR Side Effects

Generic name: morphine

Note: This document contains side effect information about morphine. Some of the dosage forms listed on this page may not apply to the brand name Oramorph SR.

Some side effects of Oramorph SR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to morphine: oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking morphine (the active ingredient contained in Oramorph SR) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• shallow breathing, slow heartbeat;

• stiff muscles, seizure (convulsions);

• cold, clammy skin;

• confusion, unusual thoughts or behavior;

• severe weakness, feeling like you might pass out;

• trouble swallowing;

• urinating less than usual or not at all;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects of morphine may include:

• weight loss;

• constipation, diarrhea;

• nausea, vomiting, stomach pain, loss of appetite;

• flushing (warmth, redness, or tingly feeling);

• headache, dizziness, spinning sensation;

• memory problems; or

• sleep problems (insomnia), strange dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to morphine: compounding powder, injectable solution, injectable tablet soluble, intravenous solution, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release, rectal suppository

Nervous system

Central nervous system side effects may be either depressant or excitatory. Excitatory symptoms are sometimes ignored as possible side effects of morphine (the active ingredient contained in Oramorph SR) Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.

Patients receiving continuous infusion of morphine sulfate via indwelling intrathecal catheter should be monitored for new neurologic signs or symptoms. Further assessment or intervention should be based on the clinical condition of the individual patient.

Myoclonic spasms may occur in patients receiving high dose morphine, particularly in the setting of renal dysfunction. Hyperalgesia has also been reported with high doses.

Nervous system side effects have been frequently reported and include drowsiness and sedation. Inflammatory masses including granulomas (some of which have resulted in serous neurologic impairment including paralysis) have been reported to occur in patients receiving continuous infusion of opioid analgesics including morphine sulfate via indwelling intrathecal catheter. Delirium, seizures, tremors, dizziness, muscle twitches, malaise, and confusion have also been reported.

Respiratory

Respiratory side effects including respiratory depression have been reported frequently. Bronchospasm has been reported in patients with underlying pulmonary disease.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, dyspepsia, constipation, dry mouth, increased gastroesophageal reflux, intestinal obstruction, and increased biliary pressure have been reported.

Morphine may cause constriction of the common bile duct and spasm of the sphincter of Oddi, thereby increasing intrabiliary pressure and worsening, rather than relieving, biliary colic.

In addition, morphine may cause intense but uncoordinated duodenal contraction and decreased gastric emptying.

Other

Withdrawal symptoms have been reported to have included agitation, restlessness, anxiety, piloerection, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Other side effects include a withdrawal symptoms after either abrupt cessation or fast tapering of morphine.

Cardiovascular

Cardiovascular side effects including hypotension related to a transient decrease in systemic arterial resistance has been reported, particularly in the setting of myocardial infarction.

Psychiatric

Psychiatric side effects have included fearfulness, agitation, thinking disturbances, paranoia, psychosis, hypervigilance, and hallucinations.

Genitourinary

Genitourinary side effects including acute urinary retention have been reported.

The risk of acute urinary retention is very high when morphine is administered by epidural or intrathecal injection. Clinicians should be attentive to the increased risk of urosepsis in this setting, particularly if instrumentation of the urinary tract is necessary.

Hematologic

Hematologic side effects including immune thrombocytopenia has been rarely reported.

Endocrine

Endocrine side effects such as menstrual irregularities including amenorrhea have been reported. Reduced male potency and decreased libido in both men and women have also been reported.

Musculoskeletal

Musculoskeletal side effects including opioid-induced involuntary muscle hyperactivity has been reported with chronic, high doses.

Dermatologic

Dermatologic side effects including sweating, flushing, pruritus have been reported frequently. A case of acute generalized exanthematous pustulosis has also been reported.

Ocular

Ocular side effects include keratoconjunctivitis and allergic conjunctivitis associated with lid urticaria. Visual disturbances and miosis have also been reported. A study has reported a temporary 26% decrease in pupil diameter following the administration of IV morphine (the active ingredient contained in Oramorph SR)

Hypersensitivity

Hypersensitivity reactions including anaphylactoid reactions have been reported to occur very rarely.

General

Droperidol (2.5 mg intravenously) has been used successfully to reverse the pruritus associated with epidural morphine (the active ingredient contained in Oramorph SR) 2 or 4 mg dosages. A larger dose of droperidol (5 mg) unexplainably does not appear to reverse the pruritus.

General side effects including a sense of warmth has been frequently reported.

Hepatic

Hepatic side effects including increases in hepatic enzymes have been reported infrequently.

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