Buy Opana ER (Oxymorphone Extended-Release) Overnight the Safe Way
- What Opana ER (oxymorphone extended-release) was and how it was classified
- How oxymorphone works in the body
- FDA-approved uses and controlled substance schedule
- Dosage forms, strengths, and typical dosing
- Common and serious side effects
- Drug interactions and contraindications
- Abuse-deterrent reformulation history and FDA withdrawal
- Personalized medical advice or treatment recommendations
- Specific dosing for your individual condition
- Information about purchasing medications
- Alternatives to prescribed treatments (consult your provider)
Opana ER was withdrawn from the US market in June 2017 at the request of the FDA. It is no longer commercially available. If you were previously taking Opana ER, your healthcare provider should have transitioned you to an alternative pain medication. Never use Opana ER obtained from unofficial sources, as it may be counterfeit and contain dangerous substances. Immediate-release oxymorphone (Opana IR) remains available.
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What Is Opana ER?
Opana ER was the brand name for oxymorphone extended-release, a potent, extended-release opioid analgesic. Oxymorphone is a semi-synthetic opioid derived from thebaine and is one of the more potent opioids available, approximately 3 to 7 times more potent than morphine on a milligram basis.
The extended-release formulation was designed to provide around-the-clock pain relief for patients with chronic pain requiring continuous opioid therapy. It was specifically indicated for use in opioid-tolerant patients — those who have been taking opioids and have developed tolerance.
Opana ER was designated as a Schedule II controlled substance. In 2012, it was reformulated with abuse-deterrent properties. However, despite this reformulation, the FDA requested its withdrawal from the US market in June 2017 due to ongoing concerns about abuse, particularly intravenous abuse.
How Oxymorphone Works
Oxymorphone works by binding to mu-opioid receptors in the central nervous system, producing potent analgesia. It is one of the most potent opioids available.
The extended-release formulation was designed to release oxymorphone gradually over 12 hours, providing consistent pain relief throughout the day. The tablet contained a non-deformable polymer matrix that was designed to resist crushing, chewing, or dissolution — intended to deter abuse.
Oxymorphone has an oral bioavailability of approximately 10% due to extensive first-pass hepatic metabolism. Its active metabolite, oxymorphone-3-glucuronide, has analgesic activity.
FDA Schedule & Classification
| Drug Name | Opana ER (oxymorphone extended-release) |
|---|---|
| Drug Class | Opioid Agonist |
| DEA Schedule | Schedule II (C-II) |
| Controlled Substance Act | High potential for abuse; severe psychological or physical dependence |
| Prescription Required | Yes (when it was available) |
| Potency | Approximately 3—7 times morphine equivalent |
| Market Status | Withdrawn from US market (June 2017) |
FDA-Approved Uses
When it was available, Opana ER was FDA-approved for:
- Chronic pain management: For use in opioid-tolerant patients requiring around-the-clock opioid analgesia for an extended period
- Not for use as an as-needed (PRN) analgesic
- Not for use in opioid-naive patients (patients not already taking opioids)
Opana ER was reserved for severe chronic pain that could not be managed with other opioid analgesics, due to its high potency and abuse potential.
Dosage Forms & Strengths
Extended-Release Tablets (Withdrawn)
| Strength | Color/Description | Typical Dose Range |
|---|---|---|
| 5 mg | Blue, round | 5 mg every 12 hours |
| 10 mg | White, round | 10 mg every 12 hours |
| 15 mg | Light orange, round | 15 mg every 12 hours |
| 20 mg | Pink, round | 20 mg every 12 hours |
| 30 mg | Lavender, round | 30 mg every 12 hours |
| 40 mg | Green, round | 40 mg every 12 hours |
The usual starting dose was 5 mg every 12 hours for opioid-tolerant patients. Dose increases were made in increments of 5 to 10 mg no more frequently than every 3 to 7 days. The maximum recommended daily dose was 80 mg.
Immediate-Release (Opana IR) — Still Available
Immediate-release oxymorphone (Opana IR) is not affected by the withdrawal and remains available as a Schedule II controlled substance for the management of acute pain:
| Strength | Typical Starting Dose |
|---|---|
| 5 mg | 5 to 10 mg every 4 to 6 hours |
| 10 mg | 10 to 20 mg every 4 to 6 hours |
| 20 mg | 20 to 40 mg every 4 to 6 hours |
| 40 mg | Individualized |
Side Effects
Common Side Effects
- Constipation
- Nausea and vomiting
- Headache
- Sedation and drowsiness
- Dizziness
- Pruritus (itching)
- Insomnia
- Dry mouth
- Excessive sweating
Serious Side Effects
Contact your healthcare provider or seek emergency medical attention if you experience:
- Respiratory depression — the primary cause of opioid-related death
- Severe allergic reaction (anaphylaxis)
- Severe hypotension
- Adrenal insufficiency
- QT prolongation
- Serotonin syndrome
Drug Interactions
Major Interactions (Avoid or Use Extreme Caution)
- Other opioids — concurrent use increases risk of respiratory depression
- Benzodiazepines — profound sedation, respiratory depression, coma, and death; FDA black box warning
- Alcohol — significantly increases sedation and respiratory depression
- MAO inhibitors — potentially fatal interaction
- Serotonergic drugs — risk of serotonin syndrome
- CYP3A4 inhibitors — may increase oxymorphone levels
Moderate Interactions (Monitor Closely)
- Anticholinergic drugs — additive constipation and urinary retention
- Mixed agonist-antagonist opioids (buprenorphine, nalbuphine) — may reduce analgesic effect
- CYP inducers (rifampin, phenytoin) — may decrease oxymorphone effectiveness
Reformulation & FDA Withdrawal
Original Formulation (2006—2012)
Opana ER was originally approved in 2006 as a standard extended-release tablet. It quickly became a drug of abuse, with users discovering they could crush and dissolve the tablets for intranasal or intravenous use.
Abuse-Deterrent Reformulation (2012)
In 2012, Endo Pharmaceuticals reformulated Opana ER with abuse-deterrent properties. The new formulation used an Enzymatic Coating Technology designed to resist crushing and dissolve slowly in liquid. The reformulation was intended to deter snorting and injection.
However, the reformulation was not effective at preventing abuse. Users discovered that dissolving the tablets in water and then injecting the solution could still deliver the drug intravenously. This led to outbreaks of:
- HIV infections in Indiana (2015)
- Hepatitis C infections in multiple states
- These outbreaks were directly linked to IV abuse of reformulated Opana ER
FDA Withdrawal Request (June 2017)
In June 2017, the FDA requested that Endo Pharmaceuticals voluntarily withdraw Opana ER from the US market. The FDA concluded that the benefits of the reformulated product no longer outweighed its risks, based on:
- Continued significant abuse, particularly IV abuse
- Outbreaks of HIV and hepatitis C associated with Opana ER injection
- The failure of the abuse-deterrent reformulation to meaningfully reduce abuse
This was one of the first times the FDA requested the withdrawal of an already-marketed drug product for reasons of public health safety.
When to Contact a Clinician
- You were previously taking Opana ER and have not been transitioned to an alternative medication
- You are experiencing uncontrolled chronic pain that is not being adequately managed
- You are considering using any form of oxymorphone without a prescription
- You are experiencing new or worsening side effects from any pain medication
- You are experiencing mood changes, depression, or thoughts of self-harm
- You have questions about opioid pain management options
Seek emergency care immediately if you experience difficulty breathing, severe allergic reaction, loss of consciousness, or symptoms of overdose.
References
- FDA — Requesting Withdrawal of All Opana ER Products
- MedlinePlus — Oxymorphone (National Library of Medicine)
- PubChem — Oxymorphone (National Institutes of Health)
- DEA — Controlled Substance Schedules
- CDC — Notes from the Field: HIV Infection Outbreak — Indiana, 2015
- FDA — Abuse-Deterrent Opioid Drugs Guidance