Applies to prucalopride: oral tablet.

Serious side effects of Prucalopride

Along with its needed effects, prucalopride may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking prucalopride:

Less common

• Frequent urination of small amounts of urine in the daytime
• headache, severe and throbbing

Rare

• Chest pain or discomfort
• confusion
• difficulty in speaking
• double vision
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• slow speech
• sweating
• thoughts or attempts at killing oneself
• troubled breathing
• vomiting

Incidence not known

• Hives or welts, itching, skin rash
• redness of the skin
• swelling of the face
• tightness in the chest

Other side effects of Prucalopride

Some side effects of prucalopride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• stomach pain

Less common

• Abnormal stomach or bowel sounds
• bloated or full feeling
• decreased appetite
• dizziness
• excess air or gas in the stomach or bowels
• passing gas
• stomach distension
• unusual tiredness or weakness

For Healthcare Professionals

Applies to prucalopride: oral tablet.

General

The most commonly reported side effects included headache, abdominal pain, nausea, and diarrhea.^[Ref]

Gastrointestinal

Diarrhea occurred within the first week in 70% of those reporting the side effect, and usually resolved within a few days in 73% of the patients. Severe diarrhea occurred in approximately 1.3% of patients.^[Ref]

Very common (10% or more): Nausea (up to 19.6%), Abdominal pain (up to 16%), diarrhea (up to 13%)

Common (1% to 10%): Abdominal distention, abnormal bowel sounds, abnormal gastrointestinal sounds, dyspepsia, flatulence, rectal hemorrhage, upper abdominal pain, vomiting

Uncommon (0.1% to 1%):

Frequency not reported: Abdominal discomfort, abdominal tenderness, epigastric discomfort, lower abdominal pain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 24.2%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Tremors

Frequency not reported: Migraine^[Ref]

Headache occurred within the first 2 days in 66% of patients who reported the side effect, and usually resolved within a few days in 65% of the patients.^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, sinusitis

Postmarketing reports: Dyspnea^[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Fever/pyrexia, malaise^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Anorexia^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Immunologic

Common (1% to 10%): Influenza^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations^[Ref]

Dermatologic

Postmarketing reports: Facial edema, pruritus, rash, urticaria^[Ref]

Genitourinary

Common (1% to 10%): Polyuria, urinary tract infection

Uncommon (0.1% to 1%): Pollakiuria^[Ref]