What the label lists and what reports show
Naldemedine side effects
Naldemedine's FDA label: “Most common adverse reactions (≥2%) are: abdominal pain, diarrhea, nausea and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc.” FAERS holds 1,619 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (186 reports).
- No generic listed
Check it at the source: the naldemedine FDA label on DailyMed (effective July 25, 2025, BioDelivery Sciences International Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SYMPROIC?See " What is the most important information I should know about SYMPROIC? " The most common side effects of SYMPROIC include stomach (abdomen) pain, diarrhea, nausea and vomiting (gastroenteritis). Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMPROIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) are: abdominal pain, diarrhea, nausea and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc.
Table 2: Common Adverse Reactions Adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo in Patients with OIC and Chronic Non-Cancer Pain (12-week data from…
| Adverse Reaction | SYMPROIC 0.2 mg once daily N=621 | Placebo N=619 |
|---|---|---|
| Abdominal pain Abdominal pain includes abdominal discomfort, abdominal pain, abdominal… | 11% | 5% |
| Diarrhea | 7% | 3% |
| Nausea | 6% | 5% |
| Vomiting | 3% | 2% |
| Gastroenteritis | 3% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedSerious 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. …
Source: FDA drug label, 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?
1,619 reports list naldemedine among the medicines taken, 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. Of the 19 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Naldemedine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions