Drug
Prucalopride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Inability To Afford Medication | 135 | 127.7 | 135.6 | signal |
| 2 | Insurance Issue | 105 | 65.3 | 68.4 | signal |
| 3 | Impaired Gastric Emptying | 47 | 33.9 | 34.6 | signal |
| 4 | Product Availability Issue | 45 | 18.4 | 18.8 | signal |
| 5 | Vitamin D Deficiency | 17 | 16.0 | 16.1 | signal |
| 6 | Product Prescribing Issue | 29 | 13.1 | 13.2 | signal |
| 7 | Adrenal Insufficiency | 16 | 12.3 | 12.4 | signal |
| 8 | No Adverse Event | 175 | 9.1 | 9.7 | signal |
| 9 | Flatulence | 49 | 7.9 | 8.1 | signal |
| 10 | Hereditary Angioedema | 9 | 7.9 | 7.9 | signal |
| 11 | Drug Effect Less Than Expected | 12 | 7.8 | 7.8 | signal |
| 12 | Product Dispensing Error | 17 | 7.2 | 7.2 | signal |
| 13 | Abdominal Distension | 81 | 7.2 | 7.4 | signal |
| 14 | Seasonal Allergy | 10 | 6.5 | 6.5 | signal |
| 15 | Ileus | 8 | 6.0 | 6.0 | signal |
| 16 | Hypomagnesaemia | 9 | 6.0 | 6.0 | signal |
| 17 | Product Packaging Issue | 6 | 5.9 | 5.9 | signal |
| 18 | Gastrointestinal Pain | 7 | 5.9 | 5.9 | signal |
| 19 | Constipation | 138 | 5.9 | 6.2 | signal |
| 20 | Product Use Issue | 116 | 5.7 | 5.9 | signal |
| 21 | Brain Fog | 9 | 5.7 | 5.7 | signal |
| 22 | Hunger | 8 | 5.5 | 5.5 | signal |
| 23 | Product Prescribing Error | 14 | 5.4 | 5.5 | signal |
| 24 | Intestinal Obstruction | 22 | 5.4 | 5.4 | signal |
| 25 | Therapeutic Product Effect Decreased | 26 | 5.4 | 5.4 | signal |
| 26 | Muscle Rigidity | 7 | 5.4 | 5.4 | signal |
| 27 | Product Use Complaint | 9 | 5.3 | 5.3 | signal |
| 28 | Spinal Operation | 7 | 5.3 | 5.3 | signal |
| 29 | Migraine | 52 | 5.0 | 5.1 | signal |
| 30 | Loss Of Personal Independence In Daily Activities | 26 | 5.0 | 5.1 | signal |
| 31 | Complication Associated With Device | 7 | 4.9 | 4.9 | signal |
| 32 | Frequent Bowel Movements | 14 | 4.8 | 4.8 | signal |
| 33 | Poor Venous Access | 5 | 4.4 | 4.5 | signal |
| 34 | Limb Injury | 13 | 4.4 | 4.4 | signal |
| 35 | Infusion Site Pain | 6 | 4.3 | 4.3 | signal |
| 36 | Suicidal Ideation | 43 | 4.3 | 4.4 | signal |
| 37 | Bedridden | 6 | 4.2 | 4.2 | signal |
| 38 | Head Injury | 14 | 4.1 | 4.1 | signal |
| 39 | Therapy Interrupted | 30 | 4.0 | 4.0 | signal |
| 40 | Nightmare | 15 | 4.0 | 4.0 | signal |
| 41 | Dyskinesia | 17 | 3.8 | 3.9 | signal |
| 42 | Serotonin Syndrome | 8 | 3.8 | 3.8 | signal |
| 43 | Pharyngeal Swelling | 4 | 3.8 | 3.8 | signal |
| 44 | Impaired Quality Of Life | 6 | 3.8 | 3.8 | signal |
| 45 | Illness | 40 | 3.7 | 3.7 | signal |
| 46 | Hallucination, Visual | 8 | 3.5 | 3.5 | signal |
| 47 | Product Physical Issue | 7 | 3.2 | 3.2 | signal |
| 48 | Inappropriate Schedule Of Product Administration | 60 | 3.1 | 3.2 | signal |
| 49 | Tendon Rupture | 4 | 3.0 | 3.0 | no signal |
| 50 | Eructation | 6 | 2.9 | 2.9 | signal |
| 51 | Coeliac Disease | 3 | 2.8 | 2.8 | no signal |
| 52 | Wrong Technique In Product Usage Process | 61 | 2.8 | 2.8 | signal |
| 53 | Ovarian Cyst | 3 | 2.7 | 2.7 | no signal |
| 54 | Poor Quality Product Administered | 3 | 2.7 | 2.7 | no signal |
| 55 | Surgery | 17 | 2.7 | 2.7 | signal |
| 56 | Injury Associated With Device | 5 | 2.3 | 2.3 | no signal |
| 57 | Thyroid Cancer | 3 | 2.3 | 2.3 | no signal |
| 58 | Mania | 4 | 2.2 | 2.2 | no signal |
| 59 | Injection Site Swelling | 16 | 1.9 | 1.9 | no signal |
| 60 | Circumstance Or Information Capable Of Leading To Medication Error | 7 | 1.9 | 1.9 | no signal |
| 61 | Product Storage Error | 18 | 1.9 | 1.9 | no signal |
| 62 | Device Dislocation | 9 | 1.9 | 1.9 | no signal |
| 63 | Therapeutic Response Shortened | 6 | 1.7 | 1.7 | no signal |
| 64 | Device Defective | 3 | 1.7 | 1.7 | no signal |
| 65 | Needle Issue | 5 | 1.6 | 1.6 | no signal |
| 66 | Dermatitis Atopic | 8 | 1.5 | 1.5 | no signal |
| 67 | Intentional Self-injury | 3 | 1.4 | 1.4 | no signal |
| 68 | Injection Site Urticaria | 3 | 1.1 | 1.1 | no signal |
| 69 | Product Complaint | 3 | 1.1 | 1.1 | no signal |
| 70 | Device Use Error | 4 | 1.1 | 1.1 | no signal |
| 71 | Device Issue | 10 | 1.1 | 1.1 | no signal |
| 72 | Device Breakage | 4 | 0.9 | 0.9 | no signal |
| 73 | Device Leakage | 4 | 0.9 | 0.9 | no signal |
| 74 | Wrong Technique In Device Usage Process | 3 | 0.6 | 0.6 | no signal |