"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.
Numorphan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
- increased sweating
- blurred vision
- trouble sleeping
- loss of appetite
- slowed breathing
- difficulty urinating
- injection site reactions, or
- allergic reactions (skin rash, hives, or itching or swelling of the face)
The dosage of Numorphan is determined by the patient's age, condition, type and severity of the pain, and other factors. Numorphan may interact with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medications that can make you sleepy or slow your breathing. Tell your doctor all medications and supplements you take. If you are pregnant, only take Numorphan if the potential benefit outweighs the potential risk to the fetus. It is not known whether Numorphan passes into breast milk. Consult your doctor before breastfeeding. Stopping this medication abruptly may cause withdrawal symptoms.
Our Numorphan (oxymorphone hydrochloride) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Numorphan FDA Prescribing Information: Side Effects
As with all potent opioid analgesics, possible side effects when using NUMORPHAN (oxymorphone) include:
Central Nervous System
Drowsiness, sedation, lightheadedness, unusual tiredness or weakness, headache, dysphoria, euphoria, miosis, diplopia, blurred vision, nervousness, restlessness, confusion, mental clouding, trouble sleeping, paradoxical CNS stimulation, hallucinations, mental depression.
Ureteral spasm, urinary hesitancy or retention, antidiuretic effect.
Drug Abuse And Dependence
NUMORPHAN (oxymorphone) is a Schedule II opioid and is subject to the Federal Controlled Substances Act.
NUMORPHAN (oxymorphone) , as with other opioid drugs, can produce tolerance, psychological dependence, and physical dependence and has the potential for being abused. The addiction potential of the drug appears to be about the same as for morphine.
Withdrawal symptoms may occur when opioids are abruptly discontinued after prolonged use. Withdrawal symptoms may be characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, gooseflesh, restless sleep, and mydriasis during the first 24 hours. These symptoms often increase in severity and over the next 72 hours may be accompanied by increasing irritability, anxiety, weakness, twitching, and spasms of muscles; kicking movements; severe backaches; abdominal and leg pains; abdominal and muscle cramps; hot and cold flashes; insomnia; nausea, anorexia, vomiting, intestinal spasm, diarrhea, coryza, and repetitive sneezing; increase in body temperature, blood pressure, respiratory rate and heart rate. Because of excessive loss of fluids through sweating, vomiting and diarrhea, there is usually marked weight loss, dehydration, ketosis, and disturbances in acid-base balance. Cardiovascular collapse can occur. Without treatment most observable symptoms disappear in 5-14 days; however, there appears to be a phase of secondary or chronic abstinence which may last for 2-6 months characterized by decreasing insomnia, irritability, and muscular aches. In addition, the patient may have miosis and a slight lowering of blood pressure, pulse rate, and body temperature;respiratory centers exhibit a decreased response to the stimulatory effects of carbon dioxide.
The dose of NUMORPHAN (oxymorphone) should be gradually reduced before discontinuation in those patients who require treatment for physical dependence.
Read the entire FDA prescribing information for Numorphan (Oxymorphone)
Additional Numorphan Information
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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