Naloxegol
Naloxegol is a peripherally acting opioid antagonist used to treat opioid-induced constipation in adults with chronic non-cancer pain.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Naloxegol (Movantik) treats constipation caused by opioid pain medicine in adults with chronic non-cancer pain, blocking opioid receptors in the gut but staying out of the brain so pain relief holds; on the U.S. market since about 2013, it is usually a next step after ordinary laxatives fall short. Most people tolerate it reasonably well, though belly cramps, diarrhea and gas are common, especially in the first few days. Call your prescriber promptly for severe, persistent or worsening belly pain (which can signal a tear in the gut wall), severe diarrhea, or opioid withdrawal signs like sweating, chills and yawning.
Clinical pearls
- Take it each morning on an empty stomach, at least an hour before breakfast or two hours after eating.
- Stop your regular laxatives when you start; they may be allowed as needed if results are weak after three days.
- Avoid grapefruit and grapefruit juice; clarithromycin and heart medicines like diltiazem or verapamil also raise naloxegol levels.
- If you take methadone, extra cramping or diarrhea may actually be withdrawal, so report it rather than pushing through.
Patient information guide A plain-language walkthrough of Naloxegol, written from its FDA label.
What Naloxegol is used for
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Naloxegol treats constipation caused by opioid pain medicines.
- Movantik (oral tablet) is used for opioid-induced constipation in adults with chronic non-cancer pain.
- This includes people with chronic pain related to prior cancer or its treatment who do not need frequent (for example, weekly) opioid dose increases.
How Naloxegol works
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Opioids bind to mu-opioid receptors in the gut and slow it down. Naloxegol blocks those receptors in the digestive tract, which reduces the constipating effect of opioids.
It is a PEGylated form of naloxone (a larger version that crosses into the brain poorly). Because very little enters the brain at recommended doses, it is expected to leave opioid pain relief largely intact.
Naloxegol dosage
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Movantik is a tablet taken by mouth once a day in the morning. Take it on an empty stomach, at least 1 hour before your first meal or 2 hours after eating.
- Stop regular laxatives before starting. Your prescriber may allow them as needed if the response is weak after 3 days.
- You do not need to change your pain medicine dose before starting.
- Avoid grapefruit and grapefruit juice.
- If you cannot swallow it whole, it can be crushed and mixed with water, or given through a nasogastric tube.
- Stop it if your opioid is stopped.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Naloxegol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (recommended dosage)
- 25 mg once daily in the morning
- If not tolerated, reduce to 12.5 mg once daily
- Take on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal
- Renal impairment (CLcr < 60 mL/min)
- 12.5 mg once daily
- Increase to 25 mg once daily if tolerated and monitor for adverse reactions
- Starting dosage for patients with renal impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administration : Discontinue maintenance laxative therapy before starting MOVANTIK; may resume laxatives if patients have OIC symptoms after taking MOVANTIK for 3 days. (2.1) Alteration in analgesic dosing regimen prior to starting MOVANTIK is not required. (2.1) Patients receiving opioids for less than 4 weeks may be less responsive to MOVANTIK. (2.1) Take on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. (2.1) For patients who are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube, see full prescribing information. (2.1) Avoid consumption of grapefruit or grapefruit juice. (2.1 , 7.1) Discontinue if treatment with the opioid pain medication is also discontinued. (2.1) Recommended dosage : 25 mg once daily; if not tolerated, reduce to 12.5 mg once daily. (2.2) Renal Impairment (CLcr < 60 mL/min): 12.5 mg once daily; increase to 25 mg once daily if tolerated and monitor for adverse reactions. (2.3 , 8.6) 2.1 Administration Instructions Discontinue all maintenance laxative therapy prior to initiation of MOVANTIK. Laxative(s) can be used as needed if there is a suboptimal response to MOVANTIK after three days. Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required. Patients receiving opioids for less than 4 weeks may be less responsive to MOVANTIK [see Clinical Studies (14) ] . Take MOVANTIK on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. For patients who are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed to a powder, mixed with 4 ounces (120 mL) of water, and drunk immediately. The glass should be refilled with 4 ounces (120 mL) of water, stirred and the contents drunk. MOVANTIK can also be administered via a nasogastric (NG) tube, as follows: 1. Flush the NG tube with 1 ounce (30 mL) of water using a 60 mL syringe. 2. Crush the tablet to a powder in a container and mix with approximately 2 ounces (60 mL) of water. 3. Draw up the mixture using the 60 mL syringe and administer the syringe contents through the NG tube. 4. Add approximately 2 ounces (60 mL) of water to the same container used to prepare the dose of MOVANTIK. 5.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Naloxegol side effects
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The most common side effects in clinical trials were:
Common side effects
- Abdominal (belly) pain
- Diarrhea
- Nausea
- Gas (flatulence)
- Vomiting
- Headache
- Excessive sweating
When to get medical help
- Call your doctor right away if you have severe, persistent or worsening belly pain. This could signal a tear in the gut wall.
- Call your doctor if you have severe belly pain or diarrhea. These can start within a few days of beginning treatment.
- Get help if you notice opioid withdrawal symptoms such as sweating, chills, diarrhea, belly pain, anxiety, irritability or yawning.
- Seek medical help for any serious allergic reaction.
Abdominal pain was more common at the higher dose. Seek help for severe belly pain, severe diarrhea or withdrawal symptoms.
Naloxegol warnings and precautions
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- Gut perforation: A tear in the gut wall has been reported, including fatal cases, mostly in people with at-risk conditions. Stop and call your doctor for severe, persistent or worsening belly pain.
- Severe belly pain or diarrhea: Some cases led to hospitalization and usually started within days.
- Opioid withdrawal: Symptoms include sweating, chills, diarrhea, belly pain, anxiety, irritability and yawning. People on methadone had more gut side effects.
- Blood-brain barrier disruption: This may raise the risk of withdrawal or reduced pain relief.
Naloxegol interactions
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Naloxegol is processed by the CYP3A4 enzyme, so drugs that affect this enzyme matter.
- Strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole): must not be used because they raise naloxegol levels.
- Moderate CYP3A4 inhibitors (diltiazem, erythromycin, verapamil): avoid, or use a lower dose with monitoring.
- Strong CYP3A4 inducers (rifampin, carbamazepine, St. John’s Wort): not recommended because they lower naloxegol levels.
- Other opioid antagonists: avoid because of added withdrawal risk.
- Grapefruit and grapefruit juice: avoid because they can raise naloxegol levels.
- Weak inhibitors (quinidine, cimetidine): no dose change needed.
Interactions listed in the FDA-approved label
From the Naloxegol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Increase plasma naloxegol concentrations and may increase the risk of adverse reactions. Use with strong CYP3A4 inhibitors is contraindicated.
- Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil): Increased naloxegol concentrations. Avoid use; if unavoidable, decrease the dosage of MOVANTIK to 12.5 mg once daily and monitor for adverse reactions.
- Weak CYP3A4 inhibitors (e.g., quinidine, cimetidine): Clinically significant increases in naloxegol concentrations are not expected. No dosage adjustments are necessary.
- Grapefruit or grapefruit juice: Can increase plasma naloxegol concentrations. Avoid consumption of grapefruit or grapefruit juice during treatment with MOVANTIK.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort): Significantly decrease plasma naloxegol concentrations and may decrease the efficacy of MOVANTIK. Use with strong CYP3A4 inducers is not recommended.
- Other opioid antagonists: Potential for additive effect of opioid receptor antagonism and increased risk of opioid withdrawal. Avoid use of MOVANTIK with another opioid antagonist.
Read the label’s full interactions text
7 DRUG INTERACTIONS Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) : Increased naloxegol concentrations; avoid concomitant use; if unavoidable, reduce dosage to 12.5 mg once daily and monitor for adverse reactions. (2.4 , 7.1) Strong CYP3A4 inducers (e.g., rifampin) : Decreased concentrations of naloxegol; concomitant use is not recommended. (7.1) Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use. (7.1) 7.1 Effects of Other Drugs on MOVANTIK Table 2 displays the effects of other drugs on MOVANTIK. Table 2. Effects of Other Drugs on MOVANTIK Concomitant Agent Mechanism of Action Clinical Recommendation CYP3A4 Inhibitors •Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) •Increase plasma naloxegol concentrations and may increase the risk of adverse reactions [see Clinical Pharmacology (12.3) ]. •Use with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) ] . •Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) •Avoid use with moderate CYP3A4 inhibitors; if unavoidable, decrease the dosage of MOVANTIK to 12.5 mg once daily and monitor for adverse reactions [see Dosage and Administration (2.4) ] . •Weak CYP3A4 inhibitors (e.g., quinidine, cimetidine) •Clinically significant increases in naloxegol concentrations are not expected. •No dosage adjustments are necessary. •Grapefruit or grapefruit juice The effect of grapefruit juice varies widely among brands and is concentration-, dose-, and preparation-dependent. Studies have shown that it can be classified as a “strong CYP3A inhibitor” when a certain preparation was used (e.g., high dose, double strength) or as a “moderate CYP3A inhibitor” when another preparation was used (e.g., low dose, single strength). •Can increase plasma naloxegol concentrations.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Naloxegol
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- Do not use with a known or suspected bowel blockage or risk of repeated blockage.
- Do not use with strong CYP3A4 inhibitors.
- Do not use after a serious allergic reaction to Movantik or its ingredients.
- Use caution with gut conditions such as diverticular disease, Crohn’s disease, ischemic colitis, bowel tumors or recent bowel surgery, or with bevacizumab.
- Kidney impairment: a lower starting dose is used.
- Severe liver impairment: avoid.
- Pregnancy: it may cause withdrawal in the mother and baby.
- Breastfeeding is not recommended.
- Children: safety and effectiveness have not been established.
- Older adults: no dose adjustment is needed, though some may be more sensitive.
Naloxegol overdose
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Doses twice the recommended amount over 4 weeks caused more belly pain, diarrhea and nausea. No antidote is known, and dialysis was not effective at removing it. People on opioids should be watched closely for withdrawal symptoms or loss of pain relief.
What Naloxegol does in the body
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Opioids slow movement through the gut. Naloxegol blocks opioid receptors in the gut and reverses that delay. In a heart rhythm study, it did not affect the QTc interval (a heart rhythm measure). Belly pain became more likely as exposure increased, while effectiveness was similar across the dose range studied.
How your body processes Naloxegol
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Naloxegol is absorbed within about 2 hours. A high-fat meal increases absorption, which is why it is taken on an empty stomach. It is broken down mainly by the CYP3A enzyme system and leaves mostly through the stool, with a smaller share in urine. Its half-life is about 6 to 11 hours. Exposure was higher in some people with kidney impairment and in older adults studied.
How to store Naloxegol
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Store MOVANTIK at 20-25°C (68-77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Naloxegol
138 supplements and herbal products have documented interactions with Naloxegol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Naloxegol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Naloxegol — the kind of thing our pharmacy team would talk through with you at the counter.
What is naloxegol for?
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How and when should I take it?
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Can I keep taking my regular laxative?
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What side effects should I expect?
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Are there foods or medicines I should avoid?
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Can I take it if I am pregnant or breastfeeding?
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Is Naloxegol available over the counter?
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When was Naloxegol first available?
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Who makes Naloxegol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Naloxegol on HelloPharmacist
Naloxegol forms and strengths (how it comes)
Naloxegol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Movantik treats opioid-induced constipation in adults with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment when frequent opioid dose increases are not needed.
- Movantik is taken once daily in the morning on an empty stomach, at least 1 hour before the first meal or 2 hours after a meal.
- If you cannot swallow Movantik whole, the tablet can be crushed, mixed with water and drunk right away, or given through a nasogastric tube as directed.
- Stop regular laxatives before starting Movantik. Stop Movantik if your opioid pain medicine is stopped.
Naloxegol on the U.S. market: products, makers and brands
How Naloxegol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 3 Naloxegol product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Movantik; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Naloxegol is used (Medicaid data)
A general measure of how commonly Naloxegol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Naloxegol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Naloxegol prescribed? Of the 1,601 medications we measure, Naloxegol ranks #614 by Medicaid prescriptions — more than 62% of them.
Utilization by Naloxegol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
naloxegol 25 MG Oral Tablet Most dispensed
Summed across the 3 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1551782
naloxegol 12.5 MG Oral Tablet
Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1551917
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Naloxegol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 25 listed Naloxegol NDCs with Medicaid activity.
Compare Naloxegol products
A representative set of FDA-listed product records for Naloxegol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 12.5 mg | Oral | Averitas Pharma, Inc. | NDA | View NDC → |
| 25 mg | Oral | Averitas Pharma, Inc. | NDA | View NDC → |
| 25 mg | Oral | RedHill Biopharma Ltd | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Naloxegol NDCs →
Naloxegol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Naloxegol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Naloxegol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Naloxegol FDA approval history
How Naloxegol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Naloxegol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Naloxegol recalls since July 2021.
✅No Naloxegol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1551777 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1551781In current FDA listings
Look up RxCUI 1551777 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Naloxegol supply and shortage status
Whether Naloxegol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Naloxegol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 25 mg | $14.59 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 12.5 mg | $14.60 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Naloxegol brand names
Naloxegol is sold under one brand name in the FDA directory — Movantik. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Naloxegol: manufacturers and labelers
2 companies list Naloxegol products with the FDA. By number of product records, the largest are Valinor Pharma, LLC, RedHill Biopharma Ltd. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Naloxegol drug class (RxNorm)
Naloxegol belongs to the Opioid Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Naloxegol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. RedHill Biopharma Ltd is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →