Medication GuideMetoclopramide Tablets, USP
Read the Medication Guide that comes with metoclopramide tablets before you start taking it and each time you get a refill.
There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection,
metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that
comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking
with your doctor about your medical condition or your treatment.
What is the most important information I should know about Metoclopramide Tablets?
Metoclopramide Tablets can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You can not control these
movements. They may not go away even after stopping metoclopramide tablets. There is no treatment for tardive dyskinesia,
but symptoms may lessen or go away over time after you stop taking metoclopramide tablets.
Your chances for getting tardive dyskinesia go up:
- the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You
should not take metoclopramide tablets for more than 12 weeks.
- if you are older, especially if you are a woman
- if you have diabetes
It is not possible for your doctor to know if you will get tardive dyskinesia if you take metoclopramide tablets.
Call your doctor right away if you get movements you can not stop or control, such as:
- lip smacking, chewing, or puckering up your mouth
- frowning or scowling
- sticking out your tongue
- blinking and moving your eyes
- shaking of your arms and legs
See the section “What are the possible side effects of metoclopramide tablets?” for more information about side effects. What is metoclopramide tablet?
Metoclopramide tablets are a prescription medicine used:
- in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain
other treatments do not work. Metoclopramide tablets relieves daytime heartburn and heartburn after meals. It also helps
ulcers in the esophagus to heal.
- to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide tablet helps treat symptoms such
as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at
the same time.
It is not known if metoclopramide tablets are safe and works in children.
Who should not take Metoclopramide tablets?
Do not take metoclopramide tablet if you:
What should I tell my doctor before taking Metoclopramide tablets?Tell your doctor about all your medical conditions
- have stomach or intestine problems that could get worse with metoclopramide tablets, such as bleeding, blockage or a tear
in the stomach or bowel wall
- have an adrenal gland tumor called a pheochromocytoma
- are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients
in metoclopramide tablets.
- take medicines that can cause uncontrolled movements, such as medicines for mental illness
- have seizures
, including if you have:
- Parkinson’s disease
- high blood pressure
- kidney problems. Your doctor may start with a lower dose.
- liver problems or heart failure. Metoclopramide tablets may cause your body to hold fluids.
- diabetes. Your dose of insulin may need to be changed.
- breast cancer
- you are pregnant or plan to become pregnant. It is not known if metoclopramide tablets will harm your unborn baby.
- you are breast-feeding. Metoclopramide tablets can pass into breast milk and may harm your baby. Talk with your doctor about
the best way to feed your baby if you take metoclopramide tablets.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal
supplements. Metoclopramide tablet and some other medicines may interact with each other and may not work as well, or cause possible side
effects. Do not start any new medicines while taking metoclopramide tablet until you talk with your doctor.
Especially tell your doctor if you take:
- another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets or metoclopramide oral
- a blood pressure medicine
- a medicine for depression, especially an Monoamine Oxidase Inhibitor (MAOI)
- a medicine that can make you sleepy, such as anti-anxiety medicine, sleep medicines, and narcotics.
If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. How should I take metoclopramide tablets
What should I avoid while taking metoclopramide tablets?
- Metoclopramide Tablets, USP comes as a tablet you take by mouth.
- Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you.
- You should not take metoclopramide tablets for more than 12 weeks.
- If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away.
What are the possible side effects of metoclopramide tablets?Metoclopramide tablets can cause serious side effects, including:
- Do not drink alcohol while taking metoclopramide tablets. Alcohol may make some side effects of metoclopramide tablets worse,
such as feeling sleepy.
- Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide tablets affects you.
Metoclopramide tablets may cause sleepiness.
- Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need to know about metoclopramide tablets?”
- Uncontrolled spasms of your face and neck muscles, or muscles of your body,arms, and legs (dystonia).
These muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of
treatment. These spasms happen more often in children and adults under age 30.
- Depression, thoughts about suicide, and suicide. Some people who take metoclopramide tablets become depressed.You may have thoughts about hurting or killing yourself. Some
people who take metoclopramide tablets have ended their own lives (suicide).
- Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide tablet. NMS can cause death and must be
treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat,
and increased sweating.
- Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson’s
disease, your symptoms may become worse while you are receiving metoclopramide tablets.
Call your doctor and get medical help right away if you:
- feel depressed or have thoughts about hurting or killing yourself
- have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
- have muscle movements you cannot stop or control
- have muscle movements that are new or unusual
Common side effects of metoclopramide tablets include:
- feeling restless, sleepy, tired, dizzy, or exhausted
- trouble sleeping
You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You
may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping (withdrawal) metoclopramide
tablets such as headaches, and feeling dizzy or nervous.
Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA-1088. How should I store metoclopramide tablets?
- Keep metoclopramide tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
- Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly.
Keep metoclopramide tablets and all medicines out of the reach of children.
General information about metoclopramide tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets
for a condition for which it was not prescribed. Do not give metoclopramide tablets to other people, even if they have the
same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about metoclopramide tablets. If you would like more information,
talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide tablets that is written
for health professionals. What are the ingredients in Metoclopramide Tablets, USP?Active ingredient:
metoclopramideInactive ingredients:Metoclopramide Tablets, USP 10 mg:
Colloidal silicon dioxide, Corn starch, Pregelatinized starch, Magnesium stearate, Mannitol, Microcrystalline cellulose.
Metoclopramide Tablets, USP 5 mg:
Colloidal silicon dioxide, Corn starch, D&C yellow # 10 (15 –20) aluminium lake, FD&C blue # 1 (11 –13) aluminium lake, Pregelatinized
starch, Magnesium stearate, Mannitol, Microcrystalline cellulose. Manufactured for: Northstar Rx LLC
Memphis, TN 38141 Toll Free Number:
This Medication Guide has been approved by the U.S. Food and Drug Administration.