Kadian Side Effects Center

Last updated on RxList: 8/5/2021
Kadian Side Effects Center

What Is Kadian?

Kadian (morphine sulfate) is a narcotic pain reliever used to treat moderate to severe pain. Short-acting morphine is taken as needed for pain. Extended-release morphine is for use when around-the-clock pain relief is needed. Kadian is available in generic form.

What Are Side Effects of Kadian?

Common side effects of Kadian include:

  • nausea,
  • vomiting,
  • stomach pain,
  • loss of appetite,
  • constipation,
  • diarrhea,
  • lightheadedness,
  • headache,
  • dizziness,
  • spinning sensation,
  • drowsiness,
  • weight loss,
  • flushing (warmth, redness, or tingly feeling),
  • memory problems,
  • sleep problems (insomnia), or
  • strange dreams.

Tell your doctor if you have serious side effects of Kadian including:

Dosage for Kadian

Physicians will individualize treatment with Kadian using a progressive plan of pain management.

What Drugs, Substances, or Supplements Interact with Kadian?

Kadian may interact with MAO inhibitors, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, other medicines that can make you sleepy or slow your breathing, pentazocine, nalbuphine, butorphanol, or buprenorphine. Tell your doctor all medications you are taking.

Kadian During Pregnancy or Breastfeeding

During pregnancy, Kadian should be used only when prescribed. Using it near the expected delivery date is not recommended because of potential harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Do not stop taking Kadian (morphine) suddenly, or you could have withdrawal symptoms.

Additional Information

Our Kadian (morphine sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Kadian Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • slow heart rate, sighing, weak or shallow breathing, breathing that stops;
  • chest pain, fast or pounding heartbeats;
  • extreme drowsiness, feeling like you might pass out;
  • serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • drowsiness, dizziness, tiredness;
  • constipation, stomach pain, nausea, vomiting;
  • sweating; or
  • feelings of extreme happiness or sadness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Kadian Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Risks from Concomitant Use with Benzodiazepine or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Risks of Use in Patients with Gastrointestinal Conditions [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Seizures in Patients with Seizure Disorders [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the randomized study, the most common adverse reactions with KADIAN therapy were drowsiness, constipation, nausea, dizziness, and anxiety. The most common adverse reactions leading to study discontinuation were nausea, constipation (may be severe), vomiting, fatigue, dizziness, pruritus, and somnolence.

Clinical trial patients with chronic cancer pain (n=227)
(AE by Body System as seen in 2% or more of patients)
Percentage %
CENTRAL NERVOUS SYSTEM 28
  Drowsiness 9
  Dizziness 6
  Anxiety 5
  Confusion 4
  Dry mouth 3
  Tremor 2
GASTROINTESTINAL 26
  Constipation 9
  Nausea 7
  Diarrhea 3
  Anorexia 3
  Abdominal pain 3
  Vomiting 2
BODY AS A WHOLE 16
  Pain 3
  Disease progression 3
  Chest pain 2
  Diaphoresis 2
  Fever 2
  Asthenia 2
  Accidental injury 2
RESPIRATORY 3
  Dyspnea 3
SKIN & APPENDAGES 3
  Rash 3
METABOLIC & NUTRITIONAL 3
  Peripheral edema 3
HEMIC & LYMPHATIC 4
  Anemia 2
  Leukopenia 2

In clinical trials 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 2% of patients in the clinical trials were:

  • Body as a Whole: Headache, chills, flu syndrome, back pain, malaise, withdrawal syndrome
  • Cardiovascular: Tachycardia, atrial fibrillation, hypotension, hypertension, pallor, facial flushing, palpitations, bradycardia, syncope
  • Central Nervous System: Confusion, anxiety, abnormal thinking, abnormal dreams, lethargy, depression, 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: Dysphagia, dyspepsia, stomach atony disorder, gastro-esophageal reflux, delayed gastric emptying, biliary colic
  • Hemic and Lymphatic: Thrombocytopenia
  • Metabolic and Nutritional: Hyponatremia, edema
  • Musculoskeletal: Back pain, bone pain, arthralgia
  • Respiratory: Hiccup, rhinitis, atelectasis, asthma, hypoxia, respiratory insufficiency, voice alteration, depressed cough reflex, non-cardiogenic pulmonary edema
  • Skin and Appendages: 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
Four-Week Open-Label Safety Study

In the open-label, 4-week safety study, 1418 patients ages 18 to 85 with chronic, non-malignant pain (e.g., back pain, osteoarthritis, neuropathic pain) were enrolled. 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.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of morphine. Because these reactions are 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.

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 KADIAN.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with KADIAN.

Table 1: Clinically Significant Drug Interactions with KADIAN

Alcohol
Clinical Impact: Concomitant use of alcohol with KADIAN can result in an increase of morphine plasma levels and potentially fatal overdose of morphine.
Intervention: Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on KADIAN therapy [see WARNINGS AND PRECAUTIONS].
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.
Serotonergic Drugs
Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue KADIAN if serotonin syndrome is suspected.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see WARNINGS AND PRECAUTIONS].
Intervention: Do not use KADIAN in patients taking MAOIs or within 14 days of stopping such treatment.
Examples: phenelzine, tranylcypromine, linezolid
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Clinical Impact: May reduce the analgesic effect of KADIAN and/or precipitate withdrawal symptoms.
Intervention: Avoid concomitant use.
Examples: butorphanol, nalbuphine, pentazocine, buprenorphine
Muscle Relaxants
Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of KADIAN and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS]
Examples: cyclobenzaprine, metaxalone
Cimetidine
Clinical Impact: The concomitant use of cimetidine can potentiate morphine effects and increase risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of KADIAN and/or cimetidine as necessary.
Diuretics
Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when KADIAN is used concomitantly with anticholinergic drugs.
P-Glycoprotein (PGP-Inhibitors)
Clinical Impact: The concomitant use of PGP-inhibitors can increase the exposure to morphine by about two-fold and can increase risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of KADIAN and/or the PGP-inhibitor as necessary.

Read the entire FDA prescribing information for Kadian (Morphine Sulfate Extended-Release)

© Kadian Patient Information is supplied by Cerner Multum, Inc. and Kadian Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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