Prucalopride

Prucalopride is a prescription medication used for the treatment of chronic constipation for which the cause is unknown.

• Prucalopride is available under the following different brand names: Motegrity

Adult dosage

Tablet

• 1mg
• 2mg

Chronic Idiopathic Constipation

Adult and pediatric dosage

• 2 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Prucalopride include:

• headache
• abdominal pain or bloating
• nausea
• diarrhea
• dizziness
• vomiting
• gas
• fatigue

Serious side effects of Prucalopride include:

• unusual changes in mood or behavior,
• thoughts of hurting yourself, 
• trying to hurt yourself, or 
• suicide.

Rare side effects of Prucalopride include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Prucalopride has severe interactions with no other drugs.
• Prucalopride has serious interactions with no other drugs.
• Prucalopride has moderate interactions with no other drugs.
• Prucalopride has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Intestinal perforation or obstruction due to the structural or functional disorder of gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract (e.g., Crohn disease, ulcerative colitis, toxic megacolon/megarectum)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Prucalopride?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Prucalopride?”

Cautions

• Suicidal ideation and behavior
• In clinical trials, suicides, suicide attempts, and suicidal ideation reported
• A causal association between treatment and an increased risk of suicidal ideation and behavior not established
• Monitor for persistent worsening of depression or the emergence of suicidal thoughts and behaviors
• Instruct patients to discontinue immediately and contact their healthcare provider if they experience any of these symptoms

Pregnancy and Lactation

• Available data from case reports with use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes
• A pregnancy exposure registry monitors pregnancy outcomes in women exposed to the drug during pregnancy; healthcare providers are encouraged to register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/.
• Lactation
  • Prucalopride is present in breast milk
  • No data are available of effects on breastfed children or milk production
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition