Important Safety Information About METOZOLV® ODT
METOZOLV ODT can cause serious side effects including abnormal muscle movements called tardive dyskenisia (TD). You cannot control these movements, and they may not go away even after stopping METOZOLV ODT. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking METOZOLV ODT.
Call your doctor right away if you experience symptoms you cannot stop or control such as lip smacking, chewing, or puckering of your lips; frowning or scowling; sticking out of your tongue; blinking and moving your eyes; or shaking of your arms and legs.
It is not possible for your doctor to know if you will get TD if you take METOZOLV ODT. Factors that increase your risk for TD include increased age, especially for females; a diagnosis of diabetes; extended use and increased dosage of METOZOLV ODT. You should not take METOZOLV ODT for more than 12 weeks.
METOZOLV ODT can cause other serious side effects including uncontrolled muscle spasms; depression, thoughts about suicide, and suicide; a rare but potentially fatal disorder known as neuroleptic malignant syndrome (NMS), the symptoms of which include high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased swelling; Parkinsonism, the symptoms of which include slight body shaking, body stiffness, and trouble moving or keeping your balance; high blood pressure; and too much body water. If you experience any of these symptoms, call your doctor and get medical help right away.
The most common side effects of METOZOLV ODT include headache, nausea, vomiting, tiredness, and sleepiness. Tell your doctor about any side effects that bother you or do not go away.
Do not drink alcohol while taking METOZOLV ODT, as it may worsen some side effects. Do not drive, work with machines, or do dangerous tasks until you know how METOZOLV ODT affects you.
Do not take METOZOLV ODT if you have stomach or intestinal problems, such as bleeding, blockage, or a tear in your stomach or bowel wall; have an adrenal tumor (pheochromocytoma); are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medications that can cause uncontrolled movements, such as medicines for mental illness; or have seizures.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Patient Medication Guide and full Prescribing Information for METOZOLV ODT.
References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.