Prescription medicine
Naldemedine Brand names: Symproic
Naldemedine (Symproic) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $16.26 per Symproic 0.2 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the naldemedine FDA label on DailyMed (effective July 25, 2025, BioDelivery Sciences International Inc); the NDA 208854 record on Drugs@FDA; every naldemedine label on DailyMed.
Highlights of the record
FDA label of July 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSYMPROIC 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
- 0.2 mg
Tablet.
On the market
- Earliest approval on file
- March 23, 2017 Symproic, Bdsi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 13, 2033 Symproic tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $16.26 per tablet Symproic 0.2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,619 through July 30, 2026
What is naldemedine used for?
From the label: indications and usageSYMPROIC 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 cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation
FDA pharmacologic class: Opioid Antagonist.
Source: FDA drug label (SYMPROIC), NDA208854 (Bdsi), as published by BioDelivery Sciences International Inc, effective July 25, 2025 (SPL set b1a1256c-a1eb-4abe-ab1e-30e4711afd16), via openFDA; the full label on DailyMed
What does the patient leaflet for naldemedine 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 SYMPROIC?SYMPROIC may cause serious side effects, including: Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that does not go away, stop taking SYMPROIC and get emergency medical help right away. Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with SYMPROIC including sweating, chills, tearing, warm or hot feeling to your face (flush), sneezing, fever, feeling cold, abdominal pain, diarrhea, nausea, and vomiting. Tell your healthcare provider if you have any of these symptoms.
From the patient leaflet: How should I store SYMPROIC?Store SYMPROIC at room temperature between 68°F to 77°F (20°C to 25°C). Keep SYMPROIC in the bottle that it comes in. Keep SYMPROIC and all medicines out of the reach of children.
Source: FDA drug label (SYMPROIC), NDA208854 (Bdsi), as published by BioDelivery Sciences International Inc, effective July 25, 2025 (SPL set b1a1256c-a1eb-4abe-ab1e-30e4711afd16), via openFDA; the full label on DailyMed
Is there a generic for naldemedine (Symproic)?
No generic naldemedine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Symproic tablets: the compound patent runs to May 13, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naldemedine (Symproic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $16.26 per Symproic 0.2 mg tablet, up 5% from $15.51 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.
- Symproic 0.2 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Symproic 0.2 mg tablet | Brand | $16.26 per tablet | $487.68 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naldemedine been recalled?
The FDA's Enforcement Report lists 1 recall naming naldemedine since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the naldemedine label say about other medicines?
The naldemedine label names 17 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Amiodarone | drug interactions | 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) ]. … |
| Aprepitant | drug interactions | 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 … |
| Atazanavir | drug interactions | 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 … |
| Captopril | drug interactions | 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) ]. … |
| Carbamazepine | drug interactions | 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) ] … |
| Clarithromycin | drug interactions | 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 … |
| Cyclosporine | drug interactions | 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) ]. … |
| Diltiazem | drug interactions | 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 … |
| Erythromycin | drug interactions | 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 … |
| Fluconazole | drug interactions | 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 … |
| Itraconazole | drug interactions | 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 … |
| Ketoconazole | drug interactions | 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 … |
| Phenytoin | drug interactions | 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) ] … |
| Quinidine | drug interactions | 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) ]. … |
Every other medicine the naldemedine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifampin | drug interactions | Clinically Relevant Interactions Affecting Naldemedine When Co-Administered with Other Drugs Strong CYP3A Inducers (e.g., rifampin, carbamazepine, phenytoin, St. … |
| Ritonavir | drug interactions | Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact … |
| Verapamil | drug interactions | P-glycoprotein (P-gp) Inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil) Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology … |
Source: FDA drug label (SYMPROIC), NDA208854 (Bdsi), as published by BioDelivery Sciences International Inc, effective July 25, 2025 (SPL set b1a1256c-a1eb-4abe-ab1e-30e4711afd16), via openFDA; the full label on DailyMed
What do FAERS reports show for naldemedine?
The FDA Adverse Event Reporting System holds 1,619 reports that list naldemedine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 457 are coded as a death and 678 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
- Naldemedine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other