General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Symproic

NALDEMEDINE

1 INDICATIONS AND USAGE SYMPROIC 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. SYMPROIC 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 canc...

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:SYMPROIC

Rx Only

SymproicMedication

Quick Reference

Medicine ClassGeneral Medicine

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: NALDEMEDINE
Medicine class: General Medicine
Brand names: SYMPROIC
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half-life of naldemedine is 11 hours
FDA approved: Yes

Symproic (NALDEMEDINE) medication overview

What Is Symproic?

Symproic (NALDEMEDINE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Symproic. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Symproic with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Symproic is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

SYMPROIC 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 ( 1 )

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

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.

Available Forms

Available Strengths

View Complete Dosage Guide

Side Effects

Common

6 ADVERSE REACTIONS Serious and important adverse reactions described elsewhere in labeling include: Gastrointestinal perforation [see Warnings and Precautions (5.1) ] Opioid withdrawal [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥2%) are: abdominal pain, diarrhea, nausea and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc.
at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to SYMPROIC in 1163 patients in clinical trials, including 487 patients with exposures greater than six months and 203 patients with exposures of 12 months.
The following safety data are derived from three double-blind, placebo-controlled trials in patients with OIC and chronic non-cancer pain: two 12-week studies (Studies 1 and 2) and one 52-week study (Study 3) [see Clinical Studies (14) ].
In Studies 1 and 2, patients on laxatives were required to discontinue their use prior to study enrollment.
All patients were restricted to bisacodyl rescue treatment during the study.

Serious

5 WARNINGS AND PRECAUTIONS Gastrointestinal perforation : Consider the overall risk benefit in patients with known or suspected lesions of the GI tract.
Monitor for severe, persistent, or worsening abdominal pain;
discontinue if development of symptoms ( 5.1 ) Opioid withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier.
Monitor symptoms of opioid withdrawal ( 5.2 ) 5.1 Gastrointestinal Perforation Cases of gastrointestinal (GI) perforation have been reported with use of another peripherally acting opioid antagonist, including SYMPROIC.
Postmarketing cases of GI perforation, including fatal cases, were reported when SYMPROIC was used in patients at risk of GI perforation (e.g., GI cancer, past GI surgery, diverticulitis, chemotherapy/radiation).

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

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Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS Gastrointestinal perforation : Consider the overall risk benefit in patients with known or suspected lesions of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if development of symptoms ( 5.1 ) Opioid withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier. Monitor symptoms of opioid w

How Symproic Works

12.1 Mechanism of Action Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB). Naldemedine is also a substrate of the P-glycoprotein (P-gp) efflux transporter. Based on these properties, the CNS penetration of naldemedine is expected to be negligible at the recommended dose levels, limiting the potential for interference with centrally-mediated opioid ana

Pharmacokinetics

Absorption

Absorption Following oral administration, naldemedine is absorbed with a time to achieve peak concentrations (T max ) of approximately 0

Half-Life

half-life of naldemedine is 11 hours

Metabolism

Metabolism Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with minor contribution from UGT1A3 to form naldemedine 3-G

Excretion

Excretion Following oral administration of [ 14 C]-labeled naldemedine, the total amount of radioactivity excreted in the urine and feces was 57% and 35% of the administered dose of naldemedine, respe

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Symproicwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

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) [see USP Controlled Room Temperature].

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Symproic
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy

Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.