August 1, 2014
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ratio-Domperidone

(domperidone)

DIN (Drug Identification Number)

01912070 RATIO-DOMPERIDONE 10MG TABLET

What side effects are possible with ratio-Domperidone?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • breast pain
  • drowsiness
  • dry mouth
  • headache
  • hot flashes
  • nausea

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breast milk flowing from the nipple
  • burning, difficult, or painful urination
  • fast, pounding, or racing heartbeat or pulse
  • difficulty with normal body movement
  • loss of balance or muscle control
  • menstrual irregularities
  • swelling of the breast (males)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • dizziness or fainting
  • irregular heart beat
  • signs of an allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for ratio-Domperidone?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Heart rhythm problems and cardiac arrest: Recent studies have shown that the risk of serious abnormal heart rhythms or cardiac arrest (sudden death) may be higher in people who take more than 30 mg of domperidone per day, or in people who are more than 60 years old. If you have a heart condition with abnormal electrical activity of your heart (e.g., QT prolongation), heart failure, or low blood levels of magnesium or potassium, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This is especially important if you are taking other medications that can change the electrical activity of the heart. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, ondansetron, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with domperidone if possible. You are more at risk for this type of abnormal heart rhythm and its complications if you:

  • are female
  • are older than 65 years of age
  • have a family history of sudden cardiac death
  • have a history of heart disease or abnormal heart rhythms
  • have a slow heart rate
  • have congenital prolongation of the QT interval
  • have diabetes
  • have had a stroke
  • have low potassium, magnesium, or calcium levels
  • have nutritional deficiencies

Hormone levels: This medication may increase prolactin, a hormone in the body. If you have a history of breast cancer, ask your doctor about the benefits and risks associated with using this medication, since some breast cancers are thought to be prolactin-dependent.

Kidney function: Reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed..

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking domperidone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with ratio-Domperidone?

There may be an interaction between domperidone and any of the following:

  • alfuzosin
  • amantadine
  • amiodarone
  • anticholinergics (e.g., benztropine, dimenhydrinate, diphenhydramine, oxybutinin)
  • antimalarials (e.g., chloroquine)
  • antipsychotic medications (e.g., haloperidol, risperidone, quetiapine)
  • aprepitant
  • "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
  • chloral hydrate
  • ciprofloxacin
  • cisapride
  • conivaptan
  • cyclosporine
  • dasatinib
  • diltiazem
  • disopyramide
  • famotidine
  • flecainide
  • formoterol
  • grapefruit juice
  • HIV protease inhibitors (e.g., indinavir, atazanavir, lopinavir, nelfinavir, ritonavir)
  • imatinib
  • indapamide
  • lithium
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • metronidazole
  • mifepristone
  • nefazodone
  • nilotinib
  • octreotide
  • oxytocin
  • pentamidine
  • pimozide
  • procainamide
  • propafenone
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, levofloxacin)
  • sotalol
  • SSRIs (e.g., paroxetine, citalopram, fluoxetine)
  • serotonin antagonists (e.g., dolasetron, granisetron, ondansetron)
  • sulfamethoxazole
  • tacrolimus
  • tamoxifen
  • tetracycline
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, nortriptyline)
  • trimethoprim
  • vardenafil
  • venlafaxine
  • vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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