Oxymorphone — uses, dosing, side effects & the brands that sell it · pharmaranks
Oxymorphone: uses, dosing, side effects & brands
Oxymorphone is an opioid agonist sold in the U.S. under 3 brand and generic names, for pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Opana ER (application NDA021610). Other oxymorphone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Oxymorphone hydrochloride should be taken on an empty stomach, at least one hour prior to or two hours after eating. ( 2.1 ) • Oxymorphone hydrochloride should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Oxymorphone hydrochloride for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1 , 5 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with oxymorphone hydrochloride. Consider this risk when…
Oxymorphone 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 ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] • Opioid-induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.6 )] • Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.9 )] • Severe Hypotension [see Warnings and Precautions ( 5.10 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.12 )] • Seizures [see Warnings and Precautions ( 5.13 )] • Withdrawal [see Warnings and Precautions ( 5.14 )] Adverse Reactions (≥ 2% of patients): Nausea, pyrexia, somnolence, vomiting, pruritus, headache, dizziness, constipation, and confusion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Adult Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the…
Every oxymorphone product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Oxymorphone pill imprints
Imprint
Strength
Colour
Shape
Maker
K;71
10 mg
red
round
—
K;70
5 mg
blue
round
—
G71
5 mg
purple
round
—
G75
7.5 mg
gray
round
—
G72
10 mg
orange
round
—
G76
15 mg
white
Frequently asked questions
What is oxymorphone?
Oxymorphone Hydrochloride Tablets, USP are an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride USP is (5α)-4,5-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80. The molecular formula is C 17 H 19 NO 4 • HCl and it has the following chemical structure. Oxymorphone hydrochloride, USP is white to off-white powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The inactive ingredients in Oxymorphone Hydrochloride Tablets, USP include: magnesium stearate, microcrystalline cellulose and pregelatinized starch. Each tablet meets the requirement of the Test 2 Dissolution in the USP monograph for Oxymorphone Hydrochloride Tablets, USP. chem.jpg
What kind of drug is oxymorphone?
The FDA classifies oxymorphone as an opioid agonist. Opioid agonists bind opioid receptors (mainly mu receptors) on nerves in the brain and spinal cord, dampening the release of pain-signaling chemicals so fewer pain messages reach the brain, which relieves moderate to severe pain. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take oxymorphone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run oxymorphone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is oxymorphone sold under?
We track 3 oxymorphone-containing products in the U.S.: Numorphan, Opana and Opana ER. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does oxymorphone come in?
Across the brands we track, oxymorphone is currently marketed as suppository, tablet, injectable and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take oxymorphone
Oxymorphone hydrochloride is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions ( 5.2 )] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.7 )] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.12 )] • Hypersensitivity to oxymorphone (e.g., anaphylaxis, angioedema) or [see Warnings and Precautions ( 5.8 ), Adverse Reactions ( 6 )] • Moderate or severe hepatic impairment [see Warnings and Precautions ( 5.16 )] . • Significant respiratory depression ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) • Known hypersensitivity to oxymorphone, any other ingredients in oxymorphone hydrochloride ( 4 ) • Moderate or severe hepatic impairment ( 4 )
Oxymorphone drug interactions
Table 2 includes clinically significant drug interactions with oxymorphone hydrochloride. Table 2: Clinically Significant Drug Interactions with Oxymorphone Hydrochloride Alcohol Clinical Impact: The concomitant use of alcohol with oxymorphone hydrochloride can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone. Intervention: Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on oxymorphone hydrochloride therapy [see Clinical Pharmacology ( 12.3 )] . Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines and 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. Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration ( 2.2 , 2.7 ), Warnings and Precautions ( 5.1…
We do not currently list a generic-labelled oxymorphone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.