REGLAN ODT SIDE EFFECTS
- Generic Name: metoclopramide orally disintegrating tablets
- Brand Name: Reglan ODT
- Drug Class: Antiemetic Agents, Prokinetic Agents
SIDE EFFECTS
The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
- Tardive dyskinesia
- Other extrapyramidal effects
- Neuroleptic malignant syndrome
- Depression
- Hypertension
- Fluid retention
- Hyperprolactinemia
- Effects on the ability to drive and operate machinery
The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.
Central Nervous System Disorders
- Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms
- Convulsive seizures
- Hallucinations
- Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently.
- Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents)
Endocrine Disorders
Fluid retention secondary to transient elevation of aldosterone. Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia
Cardiovascular Disorders
Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention
Gastrointestinal Disorders
Nausea, bowel disturbances (primarily diarrhea)
Hepatic Disorders
Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential
Renal And Urinary Disorders
Urinary frequency, urinary incontinence
Hematologic Disorders
Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia
Hypersensitivity Reactions
Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema
Eye Disorders
Visual disturbances
Metabolism Disorders
Porphyria
SRC: NLM .