Reglan (Metoclopramide Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency:

CNS Effects

Restlessness, drowsiness, fatigue, and lassitude may occur in patients receiving the recommended prescribed dosage of REGLAN Injection. Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation also may occur (see WARNINGS). In cancer chemotherapy patients being treated with 1-2 mg/kg per dose, incidence of drowsiness is about 70%. 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. In cancer chemotherapy patients receiving 1‑2 mg/kg per dose, the incidence is 2% in patients over the ages of 30‑35, and 25% or higher in pediatric patients and adult patients less than 30 years of age who have not had prophylactic administration of diphenhydramine. 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).

Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS).

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).

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, muscular rigidity, altered consciousness, and autonomic instability (see WARNINGS).

Endocrine Disturbances

Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS). 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 atrioventricular (AV) block (see CONTRAINDICATIONS 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.

Transient flushing of the face and upper body, without alterations in vital signs, following high doses intravenously.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO REGLAN

Possible Reglan side effects / adverse reactions in 3 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-03

Patient: 3 month old male weighing 3.2 kg (7.0 pounds)

Reactions: Insomnia, Tardive Dyskinesia

Adverse event resulted in: disablity

Suspect drug(s):
Reglan

Possible Reglan side effects / adverse reactions in 10 month old male

Reported by a consumer/non-health professional from United States on 2007-01-09

Patient: 10 month old male weighing 3.6 kg (8.0 pounds)

Reactions: Diarrhoea, Dyskinesia, Opisthotonus, Failure TO Thrive, Hypertension, Crying

Suspect drug(s):
Reglan

Other drugs received by patient: Captopril

Possible Reglan side effects / adverse reactions in 20 year old male

Reported by a physician from United States on 2007-01-16

Patient: 20 year old male weighing 72.6 kg (159.7 pounds)

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Suspect drug(s):
Reglan
    Dosage: 10mg once iv
    Indication: Nausea
    Start date: 2006-08-04

Reglan
    Dosage: 10mg once iv
    Indication: Vomiting
    Start date: 2006-08-04

Other drugs received by patient: Zofran