What the label lists and what reports show
Prucalopride side effects
Prucalopride's FDA label: “Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.” FAERS holds 2,617 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 headache (278 reports).
- Generic listed
Check it at the source: the prucalopride FDA label on DailyMed (effective July 17, 2025, Takeda Pharmaceuticals America, 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 MOTEGRITY?MOTEGRITY may cause serious side effects, including: unusual changes in mood or behavior, thoughts of hurting yourself, trying to hurt yourself, or suicide. Stop taking MOTEGRITY right away and tell your healthcare provider immediately if your depression gets worse, you feel sad, hopeless, begin to have thoughts of suicide, thoughts of hurting yourself or you have tried to hurt yourself or if you develop new depression. The most common side effects of MOTEGRITY include: headache stomach area (abdominal) pain or bloating nausea diarrhea dizziness vomiting gas fatigue These are not all the possible side effects of MOTEGRITY. 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, Takeda Pharmaceuticals America, Inc., effective July 17, 2025 (SPL set bca1e4c6-4b2b-4876-8ab3-654629c4ff1b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
Table 2: Common Adverse Reactions Reported in ≥2% of patients receiving MOTEGRITY and a rate higher than patients receiving placebo. in Double-Blind Placebo-Controlled Trials of CIC of at least 12 Weeks Duration
| Adverse Reaction | MOTEGRITY 2 mg Once Daily N=1,251 Includes 93 patients who started on MOTEGRITY 1 mg and… | Placebo N=1,279 % |
|---|---|---|
| Headache | 19 | 9 |
| Abdominal pain Includes abdominal pain, upper abdominal pain, lower abdominal pain,… | 16 | 11 |
| Nausea | 14 | 7 |
| Diarrhea | 13 | 5 |
| Abdominal distension | 5 | 4 |
| Dizziness | 4 | 2 |
| Vomiting | 3 | 2 |
| Flatulence | 3 | 2 |
| Fatigue | 2 | 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, continuedMost common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 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 represent 2,530 patients (1,251 received MOTEGRITY 2 mg once daily and 1,279 received placebo) with CIC from 6 double-blind, placebo-controlled clinical trials of 12 weeks to 24 weeks in duration. In these trials overall, patients were primarily female (76%) and white (76%). The mean age was 47 years (range 17 to 95 years) [see Clinical Studies (14) ]. Common Adverse Reactions Table 2 below summarizes the incidence (%) of common adverse reactions occurring in at least 2% of patients with CIC receiving either 2 mg of MOTEGRITY once daily or placebo and at an incidence greater than in the placebo group from the six double-blind placebo-controlled trials described above.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective July 17, 2025 (SPL set bca1e4c6-4b2b-4876-8ab3-654629c4ff1b), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,617 reports list prucalopride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 79 are coded as a death and 646 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 18 reactions below, 11 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?
- Prucalopride: 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