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.

CNS Effects

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].

Endocrine Disturbances

Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Fluid retention secondary to transient elevation of aldosterone [see CLINICAL PHARMACOLOGY].

Cardiovascular

Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure and possible AV block [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Gastrointestinal

Nausea and bowel disturbances, primarily diarrhea.

Hepatic

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.

Renal

Urinary frequency and incontinence.

Hematologic

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.

Allergic Reactions

A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.

Miscellaneous

Visual disturbances. Porphyria.

Read the entire FDA prescribing information for Reglan ODT (Metoclopramide Orally Disintegrating Tablets) »