"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
Reglan ODT Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Reglan ODT (metoclopramide) is a "prokinetic" drug used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms. It is also used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include restlessness, drowsiness, tiredness, dizziness, headache, insomnia, nausea, vomiting, diarrhea, breast tenderness or swelling, changes in menstrual periods, or urinating more than usual.
The dose of Reglan ODT is 10 mg to 15 mg taken orally up to four times daily, 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response. Reglan ODT may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), acetaminophen, cyclosporine, digoxin, glycopyrrolate, insulin, levodopa, mepenzolate, tetracycline, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, irritable bowel medications, MAO inhibitors, or medicines to treat psychiatric disorders. Tell your doctor all medications and supplements you use. Reglan ODT is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This drug can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.
Our Reglan ODT (metoclopramide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Reglan ODT in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:
- tremors or shaking in your arms or legs;
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
- any new or unusual muscle movements you cannot control.
Stop taking metoclopramide and call your doctor at once if you have any of these other serious side effects:
- slow or jerky muscle movements, problems with balance or walking;
- mask-like appearance in your face;
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
- depressed mood, thoughts of suicide or hurting yourself;
- hallucinations, anxiety, agitation, jittery feeling, trouble staying still;
- swelling, feeling short of breath, rapid weight gain;
- jaundice (yellowing of your skin or eyes); or
- seizure (convulsions).
Less serious side effects may include:
- feeling restless, drowsy, tired, or dizzy;
- headache, sleep problems (insomnia);
- nausea, vomiting, diarrhea;
- breast tenderness or swelling;
- changes in your menstrual periods; or
- urinating more than usual.
Read the entire detailed patient monograph for Reglan ODT (Metoclopramide Orally Disintegrating Tablets) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Reglan ODT FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the listing below, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration as reported in the medical literature around the time of metoclopramide's initial approval. In most instances, the reported adverse reactions data do not permit an estimate of frequency. The adverse experience profile seen with REGLAN ODT™ (metoclopramide orally disintegrating tablets) orally disintegrating tablets in 21 healthy subjects was similar to that seen with Reglan® Tablets.
Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg four times daily. Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation [see WARNINGS AND PRECAUTIONS] occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clear-cut relationship to metoclopramide. Rarely, hallucinations have been reported.
Extrapyramidal Reactions (EPS)
Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine [see WARNINGS AND PRECAUTIONS].
Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies [see WARNINGS AND PRECAUTIONS].
Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance [see WARNINGS AND PRECAUTIONS].
Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.
Neuroleptic Malignant Syndrome
Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, altered consciousness, muscular rigidity, and autonomic dysfunction [see WARNINGS AND PRECAUTIONS].
Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Fluid retention secondary to transient elevation of aldosterone [see CLINICAL PHARMACOLOGY].
Nausea and bowel disturbances, primarily diarrhea.
Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential.
Urinary frequency and incontinence.
A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clear-cut relationship to metoclopramide. Methemoglobinemia, in adults and especially with overdosage in neonates [see OVERDOSAGE]. Sulfhemoglobinemia in adults.
A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.
Visual disturbances. Porphyria.
Read the entire FDA prescribing information for Reglan ODT (Metoclopramide Orally Disintegrating Tablets) »
Additional Reglan ODT Information
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