Prescription medicine
Naloxegol Brand names: Movantik
Naloxegol (Movantik) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $14.61 per Movantik 25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the naloxegol FDA label on DailyMed (effective September 1, 2026, Averitas Pharma, Inc.); the NDA 204760 record on Drugs@FDA; every naloxegol label on DailyMed.
Highlights of the record
FDA label of September 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Forms and strengths
- 12.5 mg
- 25 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 16, 2014 Movantik, Averitas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 2, 2032 Movantik tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $14.61 per tablet Movantik 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,902 through July 30, 2026
What is naloxegol used for?
From the label: indications and usageMOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
FDA pharmacologic class: Opioid Antagonist.
Source: FDA drug label (MOVANTIK), Averitas Pharma, Inc., effective September 1, 2026 (SPL set 28596788-b73f-4247-85fc-3105f51fff5a), via openFDA; the full label on DailyMed
What does the patient leaflet for naloxegol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MOVANTIK?MOVANTIK may cause serious side effects, including: Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with MOVANTIK including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. If you take methadone to treat your pain, you may be more likely to have stomach pain and diarrhea than people who do not take methadone. Tell your health care provider if you have any of these symptoms. Severe stomach pain or diarrhea, or both severe stomach pain and diarrhea. Severe stomach pain and diarrhea can happen when you take MOVANTIK. These problems can happen within a few days after you start taking MOVANTIK and can lead to hospitalization. Stop taking MOVANTIK and call your healthcare provider right away if you have severe stomach pain or diarrhea, or both severe stomach pain and diarrhea. Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you have stomach pain that gets worse or does not go away, stop taking MOVANTIK and get emergency medical help right away.
From the patient leaflet: What should I avoid while taking MOVANTIK?Avoid eating grapefruit or drinking grapefruit juice during treatment with MOVANTIK.
From the patient leaflet: How should I store MOVANTIK?Store MOVANTIK at room temperature between 68°F to 77°F (20°C to 25°C). Safely throw away medicine that is out of date or that you no longer need. Keep MOVANTIK and all medicines out of the reach of children.
Source: FDA drug label (MOVANTIK), Averitas Pharma, Inc., effective September 1, 2026 (SPL set 28596788-b73f-4247-85fc-3105f51fff5a), via openFDA; the full label on DailyMed
Is there a generic for naloxegol (Movantik)?
No generic naloxegol is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Movantik tablets: the compound patent runs to April 2, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naloxegol (Movantik)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.61 per Movantik 25 mg tablet, up 5% from $13.93 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Movantik 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Movantik 12.5 mg tablet | Brand | $14.60 per tablet | $437.96 | +5% |
| Movantik 25 mg tablet | Brand | $14.61 per tablet | $438.40 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the naloxegol label say about other medicines?
The naloxegol label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name naloxegol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bevacizumab | warnings and precautions | … tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). |
| Carbamazepine | drug interactions | CYP3A4 Inducers •Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort) •Significantly decrease plasma naloxegol concentrations and may decrease the efficacy of MOVANTIK [see Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | Weak CYP3A4 inhibitors (e.g., quinidine, cimetidine) •Clinically significant increases in naloxegol concentrations are not expected. |
| Clarithromycin | contraindications | Patients concomitantly using strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms such as hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning [see Drug … |
| Diltiazem | drug interactions | Concomitant Agent: •Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil); Mechanism of Action: •Increase plasma naloxegol concentrations and may increase the risk of adverse reactions [see ].; Clinical Recommendation: •Avoid use with moderate CYP3A4 inhibitors; … |
| Erythromycin | drug interactions | Concomitant Agent: •Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil); Mechanism of Action: •Increase plasma naloxegol concentrations and may increase the risk of adverse reactions [see ].; Clinical Recommendation: •Avoid use with moderate CYP3A4 inhibitors; … |
| Itraconazole | drug interactions | Concomitant Agent: •Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin); Mechanism of Action: •Increase plasma naloxegol concentrations and may increase the risk of adverse reactions [see ].; Clinical Recommendation: •Use with strong CYP3A4 inhibitors is contraindicated [see ]. |
| Ketoconazole | contraindications | Patients concomitantly using strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms such as hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning [see Drug … |
| Methadone | warnings and precautions | In addition, patients receiving methadone as therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids [see Adverse Reactions (6.1) ]. |
| Quinidine | drug interactions | Weak CYP3A4 inhibitors (e.g., quinidine, cimetidine) •Clinically significant increases in naloxegol concentrations are not expected. |
| Rifampin | drug interactions | Concomitant Agent: •Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort); Mechanism of Action: •Significantly decrease plasma naloxegol concentrations and may decrease the efficacy of MOVANTIK [see ].; Clinical Recommendation: •Use with strong CYP3A4 inducers is not recommended. |
| Verapamil | drug interactions | Concomitant Agent: •Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil); Mechanism of Action: •Increase plasma naloxegol concentrations and may increase the risk of adverse reactions [see ].; Clinical Recommendation: •Avoid use with moderate CYP3A4 inhibitors; … |
Other labels that name naloxegol
Source: FDA drug label (MOVANTIK), Averitas Pharma, Inc., effective September 1, 2026 (SPL set 28596788-b73f-4247-85fc-3105f51fff5a), via openFDA; the full label on DailyMed
What do FAERS reports show for naloxegol?
The FDA Adverse Event Reporting System holds 3,902 reports that list naloxegol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 286 are coded as a death and 890 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other opioid antagonists
- the pharmacologic class, with prices and generics
- Naloxegol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other