"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.
Duramorph Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Duramorph (morphine injection) is a narcotic pain reliever (opiate-type) used to treat severe pain. Duramorph is available in generic form. Common side effects of Duramorph include nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, urinary retention, headache, or dry mouth. If Duramorph is injected, pain, redness, itching, or swelling at the injection site may occur.
The initial adult dose of Duramorph is 2 mg to 10 mg/70 kg of body weight. Duramorph may interact with naltrexone, cimetidine, rifampin, certain medications for pain, alcohol, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, other narcotic pain relievers, and psychiatric medicines. Check labels on all medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Tell your doctor about all medications you are taking. During pregnancy, Duramorph should be used only when prescribed. Infants born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor if you notice these symptoms in your newborn. This drug passes into breast milk and the effect on a nursing infant is not known. Consult your doctor before breast-feeding. Duramorph may cause withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) if you suddenly stop using it.
Our Duramorph (morphine injection) 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 Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Duramorph Overview - Patient Information: Side Effects
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
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, hallucinations, confusion), difficulty urinating, vision changes, slow/fast heartbeat, severe stomach/abdominal pain, change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Duramorph (Morphine Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Duramorph FDA Prescribing Information: Side Effects
The most serious adverse experience encountered during administration of DURAMORPH (morphine injection) is respiratory depression and/or respiratory arrest. This depression and/or respiratory arrest may be severe and could require intervention. (See WARNINGS and OVERDOSAGE.) Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid administration may result in overdosing. Single-dose neuraxial administration may result in acute or delayed respiratory depression for periods at least as long as 24 hours.
Tolerance and Myoclonus
See WARNINGS for discussion of these and related hazards.
While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines. Excitation of the central nervous system, resulting in convulsions, may accompany high doses of morphine given intravenously. Dysphoric reactions may occur after any size dose and toxic psychoses have been reported.
Single-dose epidural or intrathecal administration is accompanied by a high incidence of pruritus that is dose-related but not confined to the site of administration. Pruritus, following continuous infusion of epidural or intrathecal morphine, is occasionally reported in the literature; these reactions are poorly understood as to their cause.
Urinary retention, which may persist 10 to 20 hours following single epidural or intrathecal administration, is a frequent side effect and must be anticipated primarily in male patients, with a somewhat lower incidence in females. Also frequently reported in the literature is the occurrence of urinary retention during the first several days of hospitalization for the initiation of continuous intrathecal or epidural morphine therapy. Patients who develop urinary retention have responded to cholinomimetic treatment and/or judicious use of catheters (see PRECAUTIONS).
Constipation is frequently encountered during continuous infusion of morphine; this can usually be managed by conventional therapy.
Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation; this, generally, responds to bed rest and/or other conventional therapy.
Other adverse experiences reported following morphine therapy include-Dizziness, euphoria, anxiety, hypotension, confusion, reduced male potency, decreased libido in men and women, and menstrual irregularities including amenorrhea, depression of cough reflex, interference with thermal regulation and oliguria. Evidence of histamine release such as urticaria, wheals and/or local tissue irritation may occur. Nausea and vomiting are frequently seen in patients following morphine administration.
Pruritus, nausea/vomiting and urinary retention, if associated with continuous infusion therapy, may respond to intravenous administration of a low dose of naloxone (0.2 mg). The risks of using narcotic antagonists in patients chronically receiving narcotic therapy should be considered.
In general, side effects are amenable to reversal by narcotic antagonists.
NALOXONE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE EFFECTS AND WHENEVER DURAMORPH (morphine injection) THERAPY IS BEING INITIATED.
Drug Abuse And Dependence
Morphine sulfate is a Schedule II narcotic under the United States Controlled Substance Act (21 U.S.C. 801-886).
Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability. A patient may be at risk for developing a dependence to morphine if used improperly or for overly long periods of time. As with all potent opioids which are µ-agonists, tolerance as well as psychological and physical dependence to morphine may develop irrespective of the route of administration (intravenous, intramuscular, intrathecal, epidural or oral). Individuals with a prior history of opioid or other substance abuse or dependence, being more apt to respond to the euphorogenic and reinforcing properties of morphine, would be considered to be at greater risk.
Care must be taken to avert withdrawal in patients who have been maintained on parenteral/oral narcotics when epidural or intrathecal administration is considered. Withdrawal symptoms may occur when morphine is discontinued abruptly or upon administration of a narcotic antagonist.
Read the entire FDA prescribing information for Duramorph (Morphine Injection)
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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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