Naldemedine
Naldemedine is an opioid-blocking medicine that treats 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 1 clinical label set 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 →
Naldemedine (Symproic) treats constipation caused by opioid pain medicine in adults with chronic non-cancer pain. It blocks opioid receptors in the gut while staying mostly out of the brain, so pain relief should hold, and since reaching the market around 2017 it is usually tried once ordinary laxatives fall short. Most people tolerate it well, noticing mainly belly cramping, diarrhea or nausea. The serious risk is a tear in the stomach or bowel wall, so stop it and call your doctor for severe, lasting or worsening belly pain, and never take it with a known or suspected bowel blockage. Sweating, chills, runny nose or anxiety can signal opioid withdrawal.
Clinical pearls
- Take the once-daily tablet with or without food, and stop it whenever your opioid pain medicine is stopped.
- Avoid St. John's Wort, rifampin, carbamazepine and phenytoin, which can lower naldemedine levels and make it work poorly.
- Do not pair it with another opioid blocker, such as naloxegol or methylnaltrexone, since withdrawal becomes more likely.
- It may work less well if you have been taking opioids for less than 4 weeks.
Patient information guide A plain-language walkthrough of Naldemedine, written from its FDA label.
What Naldemedine is used for
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Naldemedine treats one condition:
- Opioid-induced constipation (OIC) in adults with chronic non-cancer pain (Symproic tablets).
- This includes people with chronic pain related to prior cancer or its treatment who do not need frequent opioid dose increases.
How Naldemedine works
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Naldemedine is an opioid antagonist, meaning it blocks opioid receptors. It acts mainly on mu-opioid receptors in the gut, which reduces the constipating effect of opioids.
It was built from naltrexone with an added side chain that makes it harder to cross into the brain. Because very little reaches the brain, it is expected to interfere little with opioid pain relief.
Naldemedine dosage
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Symproic is a tablet taken by mouth once a day, with or without food. You don't need to change your pain medicine dose first.
- People who have taken opioids for under 4 weeks may respond less well.
- Stop it if your opioid pain medicine is stopped.
- Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Naldemedine 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
- 0.2 mg orally once daily with or without food
- Alteration of analgesic dosing regimen prior to initiating SYMPROIC is not required; patients receiving opioids for less than 4 weeks may be less responsive; discontinue SYMPROIC if the opioid pain medication is discontinued
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ) : Alteration of analgesic dosing regimen prior to initiating SYMPROIC is not required Patients receiving opioids for less than 4 weeks may be less responsive to SYMPROIC Discontinue SYMPROIC if treatment with the opioid pain medication is also discontinued Dosage ( 2.2 ) : In adults, the recommended dosage is 0.2 mg once daily with or without food 2.1 Administration Alteration of analgesic dosing regimen prior to initiating SYMPROIC is not required. Patients receiving opioids for less than 4 weeks may be less responsive to SYMPROIC [see Clinical Studies (14) ] . Discontinue SYMPROIC if treatment with the opioid pain medication is also discontinued. 2.2 Adult Dosage The recommended dosage of SYMPROIC is 0.2 mg orally once daily with or without food.
Read the full Dosage and Administration section on DailyMed →
Naldemedine side effects
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The most common side effects are stomach-related.
Common side effects
- Abdominal pain
- Diarrhea
- Nausea
- Gastroenteritis (stomach or intestinal infection or upset)
- Vomiting
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 stomach or bowel wall (GI perforation).
- Call your doctor if you have symptoms of opioid withdrawal, such as sweating, chills, flushing, runny nose, sneezing, anxiety, agitation, diarrhea, nausea, or vomiting.
- Get medical help if you have a rash or trouble breathing (wheezing) after a dose. These can be allergic reactions.
Naldemedine warnings and precautions
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- GI perforation: A tear in the stomach or bowel wall has been reported, including fatal cases, mostly in people with GI risk factors. Report severe, persistent, or worsening belly pain right away.
- Opioid withdrawal: Symptoms include sweating, chills, flushing, sneezing, diarrhea, nausea, and vomiting. Risk may be higher if the blood-brain barrier is disrupted.
- Allergic reactions: Bronchospasm and rash have occurred.
Naldemedine interactions
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Some medicines change how much naldemedine is in your body.
- Strong CYP3A inducers (rifampin, carbamazepine, phenytoin, St. John's Wort): lower levels, so it may work less well. Avoid.
- Other opioid antagonists: raise the risk of withdrawal. Avoid.
- Moderate or strong CYP3A inhibitors (fluconazole, diltiazem, erythromycin, itraconazole, ketoconazole, clarithromycin, ritonavir): raise levels. Monitor for side effects.
- P-gp inhibitors (amiodarone, captopril, cyclosporine, quinidine, verapamil): raise levels. Monitor for side effects.
Interactions listed in the FDA-approved label
From the Naldemedine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Significant decrease in plasma naldemedine concentrations, which may reduce efficacy. Avoid use of SYMPROIC with strong CYP3A inducers.
- Other opioid antagonists: Potential for additive effect of opioid receptor antagonism and increased risk of opioid withdrawal. Avoid use of SYMPROIC with another opioid antagonist.
- Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A inhibitors: Increase in plasma naldemedine concentrations. Monitor for potential naldemedine-related adverse reactions.
- P-glycoprotein (P-gp) inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil): Increase in plasma naldemedine concentrations. Monitor for potential naldemedine-related adverse reactions.
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 3 includes drugs with clinically important drug interactions with SYMPROIC and instructions for preventing or managing the interaction. Table 3: Clinically Relevant Interactions Affecting Naldemedine When Co-Administered with Other Drugs Strong CYP3A Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) Clinical Impact Significant decrease in plasma naldemedine concentrations, which may reduce efficacy [see Clinical Pharmacology (12.3) ] Intervention Avoid use of SYMPROIC with strong CYP3A inducers. Other Opioid Antagonists Clinical Impact Potential for additive effect of opioid receptor antagonism and increased risk of opioid withdrawal. Intervention Avoid use of SYMPROIC with another opioid antagonist. Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] . P-glycoprotein (P-gp) Inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil) Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] . Strong CYP3A inducers (e.g., rifampin) : Decreased naldemedine concentrations; avoid concomitant use ( 7 ) Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use ( 7 ) Moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A4 inhibitors : Increased naldemedine concentrations; monitor for adverse reactions ( 7 ) P-gp inhibitors (e.g., cyclosporine) : Monitor for adverse reactions ( 7 )
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 Naldemedine
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- Do not use it with a known or suspected bowel blockage or a risk of repeat blockage.
- Do not use it if you've had an allergic reaction to naldemedine.
- Be cautious with conditions that weaken the gut wall, such as Crohn's disease or diverticulitis.
- Pregnancy: may cause opioid withdrawal in the fetus.
- Breastfeeding: talk with your doctor. Breastfeeding may resume 3 days after the last dose.
- Avoid in severe liver impairment.
- Not established for children.
- Older adults: no overall differences seen, though some may be more sensitive.
Naldemedine overdose
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In studies, higher doses caused more stomach side effects such as abdominal pain, diarrhea, nausea, and vomiting. Chills, sweating, and dizziness were also reported at higher doses. There is no known antidote, and hemodialysis does not remove it from the blood.
What Naldemedine does in the body
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Opioids slow the movement of food through the gut. Naldemedine blocks opioid receptors in the gut and reverses that delay. At up to 5 times the recommended dose, it did not lengthen the QT interval (a heart rhythm measurement) to any clinically relevant extent.
How your body processes Naldemedine
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After you swallow it, naldemedine reaches peak levels in about 45 minutes on an empty stomach. A high-fat meal slows absorption but does not change how much is absorbed. Its half-life is about 11 hours. The body breaks it down mainly through the CYP3A enzyme, and it leaves through urine and feces. Kidney problems and mild to moderate liver problems did not change its levels, and severe liver impairment was not studied.
How to store Naldemedine
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Store SYMPROIC in a light resistant container at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Naldemedine
144 supplements and herbal products have documented interactions with Naldemedine 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 · 103
- Minor · 38
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.
Naldemedine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Naldemedine — the kind of thing our pharmacy team would talk through with you at the counter.
What is naldemedine for?
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How do I take it?
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Will it take away my pain relief?
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What side effects should I expect?
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Are there medicines I should avoid with it?
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Can I take it if I'm pregnant or breastfeeding?
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Is Naldemedine available over the counter?
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When was Naldemedine first available?
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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 Naldemedine on HelloPharmacist
Naldemedine forms and strengths (how it comes)
Naldemedine 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Naldemedine inactive ingredients by manufacturer.
Tablet
How this form is used
- Symproic is used to treat opioid-induced constipation in adults with chronic non-cancer pain.
- Symproic is taken by mouth once daily, with or without food.
- Symproic does not require changing your pain medicine dosing before you start.
- Symproic should be stopped if your opioid pain medicine is stopped.
Naldemedine on the U.S. market: products, makers and brands
How Naldemedine 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.
1 company lists 1 Naldemedine product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Symproic; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Naldemedine is used (Medicaid data)
A general measure of how commonly Naldemedine 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 Naldemedine 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 Naldemedine prescribed? Of the 1,601 medications we measure, Naldemedine ranks #1,077 by Medicaid prescriptions — more than 33% of them.
Utilization by Naldemedine 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.
naldemedine 0.2 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876603
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 Naldemedine, 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 1 of 2 listed Naldemedine NDCs with Medicaid activity.
Compare Naldemedine products
A representative set of FDA-listed product records for Naldemedine — 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 | ||||
| 0.2 mg | Oral | BioDelivery Sciences International Inc | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Naldemedine NDCs →
Naldemedine 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 Naldemedine — 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 Naldemedine 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.
Naldemedine FDA approval history
How Naldemedine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Naldemedine 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 Naldemedine recalls since July 2021.
✅No Naldemedine 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 1876597 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 1876602In current FDA listingsClinical drug / strength (SCD) 0.2 MGRxCUI 1876603
Look up RxCUI 1876597 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.
Naldemedine supply and shortage status
Whether Naldemedine 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 Naldemedine 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 · Oral | 0.2 mg | $16.26 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.
Naldemedine brand names
Naldemedine is sold under one brand name in the FDA directory — Symproic. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Naldemedine: manufacturers and labelers
One company lists Naldemedine products with the FDA. By number of product records, the largest are BioDelivery Sciences International Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Naldemedine drug class (RxNorm)
Naldemedine 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 Naldemedine 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. BioDelivery Sciences International Inc 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 →