"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Kadian Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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. 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.
Physicians will individualize treatment with Kadian using a progressive plan of pain management. 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. 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 breast-feeding. Do not stop taking Kadian (morphine) suddenly, or you could have withdrawal symptoms.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kadian in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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.
Read the entire detailed patient monograph for Kadian (Morphine Sulfate Extended-Release)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Kadian Overview - Patient Information: Side Effects
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.
Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Kadian (Morphine Sulfate Extended-Release)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kadian FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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 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.
|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|
|BODY AS A WHOLE||16|
|SKIN & APPENDAGES||3|
|METABOLIC & NUTRITIONAL||3|
|HEMIC & LYMPHATIC||4|
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.
Anaphylaxis has been reported with ingredients contained in KADIAN. Advise patients how to recognize such a reaction and when to seek medical attention.
Read the entire FDA prescribing information for Kadian (Morphine Sulfate Extended-Release)
Additional Kadian Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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