Kadian Side Effects

Generic Name: morphine,morphine sulfate

Please note - some side effects for Kadian may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Kadian - for the Consumer

Kadian Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kadian Extended-Release Capsules:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; restless mood; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Kadian Extended-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); confusion; disorientation; fainting; fast, slow, or irregular heartbeat; hallucination; mental or mood changes (eg, agitation, exaggerated sense of well-being); seizures; severe or persistent constipation or stomach pain; severe or persistent drowsiness, dizziness, or headache; shortness of breath; slow or shallow breathing; sudden chest pain; swelling of the hands, ankles, or feet; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Kadian Side Effects - for the Professional

Kadian

Serious adverse reactions that may be associated with Kadian® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, apnea, circulatory depression, cardiac arrest, hypotension, and/or shock.

The less severe adverse events seen on initiation of therapy with Kadian® are also typical opioid side effects.  These events are dose dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual.  They should be expected and managed as a part of opioid analgesia.  The most frequent of these include drowsiness, dizziness, constipation and nausea.  In many cases, the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large rapid swings in plasma concentrations of the opioid.  Many of these adverse events, will cease or decrease as Kadian® therapy is continued and some degree of tolerance is developed, but others may be expected to remain troublesome throughout therapy.

Management of Excessive Drowsiness

Most patients receiving Kadian® will experience initial drowsiness.  This usually disappears within 3-5 days and is not a cause of concern unless it is excessive, or accompanied by unsteadiness or confusion.  Dizziness and unsteadiness may be associated with postural hypotension, particularly in elderly or debilitated patients, and has been associated with syncope and falls in non-tolerant patients started on opioids.

Excessive or persistent sedation should be investigated.  Factors to be considered should include: concurrent sedative medications, the presence of hepatic or renal insufficiency, hypoxia or hypercapnia due to exacerbated respiratory failure, intolerance to the dose used (especially in older patients), disease severity and the patient's general condition.

The dosage should be adjusted according to individual needs, but additional care should be used in the selection of initial doses for the elderly patient, the cachectic or gravely ill patient, or in patients not already familiar with opioid analgesic medications to prevent excessive sedation at the onset of treatment.

Management of Nausea and Vomiting

Nausea and vomiting are common after single doses of Kadian® or as an early undesirable effect of chronic opioid therapy.  The prescription of a suitable antiemetic should be considered, with the awareness that sedation may result. The frequency of nausea and vomiting usually decreases within a week or so but may persist due to opioid-induced gastric stasis. Metoclopramide is often useful in such patients.

Management of Constipation

Virtually all patients suffer from constipation while taking opioids, such as Kadian®, on a chronic basis.  Some patients, particularly elderly, debilitated or bedridden patients may become impacted.  Tolerance does not usually develop for the constipating effects of opioids.  Patients must be cautioned accordingly and laxatives, softeners and other appropriate treatments should be used prophylactically from the beginning of opioid therapy.

Adverse Events Probably Related to Kadian® Administration

In clinical studies in patients with chronic cancer pain the most common adverse events reported by patients at least once during therapy were drowsiness (9%), constipation (9%), nausea (7%), dizziness (6%), and anxiety (6%).  Other less common side effects expected from Kadian® or seen in less than 3% of patients in the clinical studies were:

Body as a Whole:  Asthenia, accidental injury, fever, pain, chest pain, headache, diaphoresis, chills, flu syndrome, back pain, malaise, withdrawal syndrome

Cardiovascular:  Tachycardia, atrial fibrillation, hypotension, hypertension, pallor, facial flushing, palpitations, bradycardia, syncope

Central Nervous System:  Confusion, dry mouth, anxiety, abnormal thinking, abnormal dreams, lethargy, depression, tremor, loss of concentration, insomnia, amnesia, paresthesia, agitation, vertigo, foot drop, ataxia, hypesthesia, slurred speech, hallucinations, vasodilation, euphoria, apathy, seizures, myoclonus

Endocrine:  Hyponatremia due to inappropriate ADH secretion, gynecomastia

Gastrointestinal:  Vomiting, anorexia, dysphagia, dyspepsia, diarrhea, abdominal pain, stomach atony disorder, gastro-esophageal reflux, delayed gastric emptying, biliary colic

Hemic & Lymphatic:  Anemia, leukopenia, thrombocytopenia

Metabolic & Nutritional:  Peripheral edema, hyponatremia, edema

Musculoskeletal:  Back pain, bone pain, arthralgia

Respiratory:  Hiccup, rhinitis, atelectasis, asthma, hypoxia, dyspnea, respiratory insufficiency, voice alteration, depressed cough reflex, non-cardiogenic pulmonary edema

Skin and Appendages:  Rash, decubitus ulcer, pruritus, skin flush

Special Senses:  Amblyopia, conjunctivitis, miosis, blurred vision, nystagmus, diplopia

Urogenital:  Urinary abnormality, amenorrhea, urinary retention, urinary hesitancy, reduced libido, reduced potency, prolonged labor

Post-marketing Adverse Events Probably Related to Kadian®

The safety of Kadian® has been evaluated in a randomized, prospective, open-label, 4-week treatment period, post-marketing study consisting of 1418 patients ages 18-85 with chronic, non-malignant pain (e.g., back pain, osteoarthritis, neuropathic pain).  No control arm was included in this study.  The most common adverse events reported at least once during therapy were constipation (12%), nausea (9%) and somnolence (3%).  Other less common side effects occurring in less than 3% of patients were vomiting, pruritus, dizziness, sedation, dry mouth, headache, fatigue and rash.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Central nervous system side effects may be either depressant or excitatory. Excitatory symptoms are sometimes ignored as possible side effects of morphine. Severe adverse effects such as respiratory depression can be treated with the opiate 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.

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 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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