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.
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REPORTS OF SUSPECTED REGLAN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Reglan. The information is not vetted and should not be considered as verified clinical evidence.
Possible Reglan side effects / adverse reactions in 74 year old male
Reported by a lawyer from United States on 2011-10-13
Patient: 74 year old male weighing 86.0 kg (189.2 pounds)
Reactions: Abdominal Pain, Rectal Polyp, Dyskinesia, Tachycardia, Clostridium Difficile Colitis, Change of Bowel Habit, Haematemesis, Dizziness, Pleural Effusion, Nausea, Anaemia, Neutropenic Sepsis, Malnutrition, Tremor, Anxiety, Small Intestinal Obstruction, Diarrhoea, Dehydration, Metastases TO Pleura, Hypertension, Asthenia
Suspect drug(s):
Reglan
Indication: Product Used FOR Unknown Indication
Start date: 1992-10-06
End date: 1992-10-10
Reglan
Start date: 2009-08-06
End date: 2009-08-07
Reglan
Start date: 2007-05-14
End date: 2007-05-21
Possible Reglan side effects / adverse reactions in 19 year old male
Reported by a lawyer from United States on 2011-10-18
Patient: 19 year old male
Reactions: Mental Impairment, Akathisia, Agitation, Completed Suicide, Extrapyramidal Disorder, Depression, GUN Shot Wound, Hallucination, Suicidal Ideation
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Reglan
Dosage: (df oral)
Administration route: Oral
Indication: Gastric Ulcer
Start date: 2008-06-12
End date: 2008-06-21
Reglan
Dosage: (df oral)
Administration route: Oral
Indication: Gastritis
Start date: 2008-06-12
End date: 2008-06-21
Possible Reglan side effects / adverse reactions in 51 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-24
Patient: 51 year old female
Reactions: Confusional State, Hyperhidrosis, Walking AID User, Feeling Cold, Myalgia, Skin Lesion, Feeling Hot, Depression, Migraine, Vomiting, Nausea, Urinary Tract Infection, Paraesthesia, Arthralgia, Diarrhoea, Suicide Attempt, Gait Disturbance, Asthenia, Anaesthesia
Adverse event resulted in: hospitalization
Suspect drug(s):
Humira
Start date: 2011-06-01
End date: 2011-06-01
Reglan
Indication: Nausea
Humira
Indication: Crohn's Disease
Start date: 2011-06-01
Humira
Start date: 2011-06-01
End date: 2011-06-01
Other drugs received by patient: Calcium Carbonate; VIT D; Multi-Vitamin; Prozac; Xanax; Prednisone; Omeprazole; Furosemide; Cymbalta; Ondansetron; Pentasa; Hydrocodone Bitartrate; Metoprolol Tartrate; Aspirin; Fish OIL; Nabumetone
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