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Reglan Side Effects

Generic Name: metoclopramide

Note: This page contains side effects data for the generic drug metoclopramide. It is possible that some of the dosage forms included below may not apply to the brand name Reglan.

For the Consumer

Applies to metoclopramide: oral solution, oral syrup, oral tablet, oral tablet disintegrating

Other dosage forms:

As well as its needed effects, metoclopramide (the active ingredient contained in Reglan) may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking metoclopramide, check with your doctor immediately:

Rare:
  • Abdominal or stomach pain or tenderness
  • chills
  • clay colored stools
  • convulsions (seizures)
  • dark urine
  • difficulty with breathing
  • difficulty with speaking or swallowing
  • dizziness or fainting
  • fast or irregular heartbeat
  • fever
  • general feeling of tiredness or weakness
  • headache (severe or continuing)
  • inability to move the eyes
  • increase in blood pressure
  • increased sweating
  • itching
  • lip smacking or puckering
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • mask-like face
  • muscle spasms of the face, neck, and back
  • nausea and vomiting
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • shuffling walk
  • skin rash
  • sore throat
  • stiffness of the arms or legs
  • swelling of the feet or lower legs
  • tic-like or twitching movements
  • trembling and shaking of the hands and fingers
  • twisting movements of the body
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin
  • weakness of the arms and legs
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking metoclopramide, get emergency help immediately:

Symptoms of overdose:
  • Confusion
  • drowsiness (severe)

Severity: Minor

Some metoclopramide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Diarrhea
  • drowsiness
  • restlessness
Less common or rare:
  • Breast tenderness and swelling
  • changes in menstruation
  • constipation
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • increased flow of breast milk
  • increased need to urinate
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • passing urine more often
  • skin rash
  • trouble sleeping
  • unusual dryness of the mouth
  • unusual irritability

For Healthcare Professionals

Applies to metoclopramide: compounding powder, injectable solution, oral concentrate, oral syrup, oral tablet, oral tablet disintegrating

General

The incidence of side effects correlates with dose and duration of metoclopramide (the active ingredient contained in Reglan) therapy.[Ref]

Nervous system

Very common (10% or more): Drowsiness/somnolence (up to 70%), extrapyramidal syndrome (EPS)/acute dystonic reactions (at least 25%)
Common (1% to 10%): Fatigue, restlessness, lassitude, parkinsonism/parkinsonian symptoms, akathisia
Uncommon (0.1% to 1%): Dystonia, depressed level of consciousness, dyskinesia, hallucinations
Rare (0.01% to 0.1%): Seizures/convulsions, dizziness, headache
Very rare (less than 0.01%): Neuroleptic malignant syndrome
Frequency not reported: Tardive dyskinesia, pseudo-parkinsonism, syncope[Ref]

Drowsiness, decreased level of consciousness, confusion, and hallucinations have higher incidences with higher doses.

Convulsive seizures have been reported, especially in patients with epilepsy; however, there is no obvious association with use of this drug.

Parkinsonian symptoms may be related to usual/excessive doses and/or decreased renal function and includes tremor, rigidity, bradykinesia, and akinesia.[Ref]

Psychiatric

Common (1% to 10%): Depression/acute depression
Uncommon (0.1% to 1%): Confusion/confusional state
Rare (0.01% to 0.1%): Trouble sleeping/insomnia, unusual irritability
Frequency not reported: Mental depression with suicidal ideation/suicide, anxiety, agitation, mania, psychosis, severe dysphoria, obsessive rumination, delirium[Ref]

Cardiovascular

Hypotension, bradycardia, shock, and other abnormalities or cardiac conduction occurred most frequently with IV formulations.

Cardiac arrest occurred shortly after IV administration, and may have been subsequent to bradycardia.

Sinus arrest and transient facial/upper body flushing occurred, particularly with IV administration. Flushing typically occurred without alterations in vital signs following high dose IVs.

Edema/fluid retention may be secondary to a transient increase in aldosterone levels.[Ref]

Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Bradycardia
Rare (0.01% to 0.1%): Edema/fluid retention, face edema
Very rare (less than 0.01%): Abnormalities of cardiac conduction (e.g., bradycardia, asystole, heart block, sinus arrest, cardiac arrest)
Frequency not reported: Hypertension, ventricular/supraventricular tachycardia, tachycardia, acute congestive heart failure, atrioventricular (AV) block, QT prolonged, Torsade de Pointes, acute hypertension/hypertensive crisis in patients with pheochromocytoma, transient flushing of the face and upper body, atrial fibrillation, ventricular fibrillation, shock, palpitations[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea
Rare (0.01% to 0.1%): Constipation, unusual dryness of the mouth, nausea
Frequency not reported: Bowel disturbances (primarily diarrhea)[Ref]

Other

Common (1% to 10%): Asthenia
Frequency not reported: Hyperthermia[Ref]

Endocrine

Uncommon (0.1% to 1%): Amenorrhea/irregular periods, hyperprolactinemia
Rare (0.01% to 0.1%): Galactorrhea
Frequency not reported: Gynecomastia/breast enlargement, transient increase in aldosterone levels[Ref]

Amenorrhea, galactorrhea, and gynecomastia occurred secondary to hyperprolactinemia during prolonged treatment.[Ref]

Hypersensitivity

Anaphylactic shock typically occurred with the IV formulation.[Ref]

Uncommon (0.1% to 1%): Hypersensitivity/hypersensitivity reactions
Very rare (less than 0.01%): Anaphylactic shock, anaphylactic/anaphylactoid reactions (e.g., tongue swelling/edema)
Frequency not reported: Angioneurotic edema (e.g., glossal/laryngoedema reactions)[Ref]

Hematologic

Leukopenia, neutropenia, and agranulocytosis typically did not have a clear-cut relationship with this drug.

Methemoglobinemia and sulfhemoglobinemia occurred with high doses of this drug. Methemoglobinemia may be related to NADH cytochrome b5 reductase deficiency or overdose, particularly in neonates. Sulfhemoglobinemia usually occurred in adults with concomitant use of high doses of sulfur-releasing products.[Ref]

Rare (0.01% to 0.1%): Leukopenia, neutropenia, porphyria, agranulocytosis
Very rare (less than 0.01%): Red cell disorders (e.g., methemoglobinemia, sulfhemoglobinemia)[Ref]

Dermatologic

Rash and urticaria typically occurred in patients with a history of asthma.[Ref]

Rare (0.01% to 0.1%): Skin rash, maculopapular rash, urticaria, pruritus[Ref]

Hepatic

Hepatotoxicity occurred with concurrent use of other potentially hepatotoxic drugs and was characterized by findings such as jaundice and altered liver function tests.[Ref]

Rare (0.01% to 0.1%): Hepatotoxicity (jaundice, altered liver function tests)
Postmarketing reports: Arteriovenous shunting and cholestasis in conjunction with hepatic hemangiomatosis[Ref]

Musculoskeletal

Dystonic reactions typically presented as upper airway obstruction with stridor and dyspnea.[Ref]

Very rare (less than 0.01%): Dystonic reaction
Frequency not reported: Muscle spasm[Ref]

Respiratory

Bronchospasm, wheezing, and dyspnea typically occurred in patients with a history of asthma.

Respiratory failure occurred secondary to dystonic reactions.[Ref]

Frequency not reported: Bronchospasm, dyspnea, respiratory failure, acute asthmatic symptoms (e.g., wheezing, dyspnea)[Ref]

Genitourinary

Frequency not reported: Urinary frequency, incontinence, sexual dysfunction, priapism, impotence[Ref]

Impotence may be secondary to hyperprolactinemia.[Ref]

Ocular

Frequency not reported: Visual disturbances[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Reglan (metoclopramide)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

It is possible that some side effects of Reglan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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