Metozolv ODT Side Effects

Generic name: metoclopramide

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Note: This document provides detailed information about Metozolv ODT Side Effects associated with metoclopramide. Some dosage forms listed on this page may not apply specifically to the brand name Metozolv ODT.

Applies to metoclopramide: nasal spray.

Other dosage forms:

• oral solution, oral tablet, oral tablet disintegrating
• solution

Important warnings This medicine can cause some serious health issues

Nasal route (solution)

Metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.

The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dosage.

Discontinue metoclopramide in patients who develop signs or symptoms of tardive dyskinesia.

Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the risk of developing tardive dyskinesia with longer-term use.

Common side effects of Metozolv ODT

Some side effects of metoclopramide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• change in or loss of taste
• drowsiness
• loss of strength or energy
• muscle pain or weakness
• unusual weak feeling

Incidence not known

• absent, missed, or irregular menstrual periods
• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• unexpected or excess milk flow from breasts

Serious side effects of Metozolv ODT

Along with its needed effects, metoclopramide (the active ingredient contained in Metozolv ODT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking metoclopramide:

Less common

• changes in behavior
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping

Incidence not known

• agitation
• black, tarry stools
• bluish-colored lips, fingernails, or palms
• blurred vision
• chest pain or tightness
• chills
• clay-colored stools
• confusion
• cough
• dark urine
• decreased urine output
• diarrhea
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or slow heartbeat
• fever
• fluid-filled skin blisters
• general feeling of tiredness or weakness
• headache
• hoarseness
• inability to move the eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• increased need to urinate
• increased sweating
• irregular breathing
• itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lip smacking or puckering
• loss of balance control
• loss of bladder control
• lower back or side pain
• mask-like face
• nausea
• need to keep moving
• nervousness
• noisy, rattling breathing
• overactive reflexes
• painful or difficult urination
• pale skin
• passing urine more often
• poor coordination
• pounding in the ears
• pounding, slow heartbeat
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• sensitivity of the skin to the sun
• severe muscle stiffness
• shivering
• shuffling walk
• slowed movements
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sticking out of the tongue
• stomach pain or tenderness
• swelling of the breasts or breast soreness in both females and males
• swelling of the face, fingers, feet, or lower legs
• talking or acting with excitement you cannot control
• thinning of the skin
• tic-like (jerky) movements of the head, face, mouth, and neck
• trembling and shaking of the fingers and hands
• trouble in breathing, speaking, or swallowing
• trouble breathing at rest
• twitching
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions
• vomiting
• weight gain
• yellow eyes or skin

For healthcare professionals

Applies to metoclopramide: compounding powder, injectable solution, nasal spray, 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 Metozolv ODT) therapy.^[Ref]

Nervous system

• Very common (10% or more): Drowsiness (up to 70%), acute dystonic reaction (up to 25%)
• Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorders, headache, parkinsonism, somnolence
• Uncommon (0.1% to 1%): Depressed level of consciousness, dyskinesia, dystonia
• Rare (0.01% to 0.1%): Bradykinesia, convulsion, dystonic reaction, tremor
• Very rare (less than 0.01%): Neuroleptic malignant syndrome
• Frequency not reported: Acute dyskinesia, acute dystonia/acute dystonic reaction, altered consciousness, autonomic instability, bulbar type of speech, choreoathetotic movements, cogwheel rigidity, convulsive seizures, extrapyramidal symptoms, facial grimacing, facial muscle spasm, fatal dystonic reaction, foot tapping, inability to sit still, involuntary movements of the extremities/face/jaw/mouth/tongue/trunk, mask-like facies, motor restlessness, opisthotonos, pacing, parkinsonian syndrome, rhythmic tongue protrusion, serotonin syndrome, syncope, tardive dyskinesia, tetanus-like reaction, unnatural position of head and shoulders^[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.

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

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

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea, vomiting
• Uncommon (0.1% to 1%): Bowel disturbances
• Rare (0.01% to 0.1%): Supraglottic dystonia
• Frequency not reported: Glossal edema^[Ref]

Other

• Common (1% to 10%): Asthenia, fatigue, lassitude
• Frequency not reported: Effects on the ability to drive/operate machinery, hyperpyrexia, hyperthemia, jitteriness^[Ref]

Psychiatric

• Common (1% to 10%): Depression, restlessness
• Uncommon (0.1% to 1%): Hallucination, insomnia
• Rare (0.01% to 0.1%): Acute depression, confusional state
• Frequency not reported: Agitation, anxiety, confusion, delirium, mania, mental depression with suicidal ideation, nervousness, obsessive rumination, severe dysphoria, suicidal ideation, suicide^[Ref]

Cardiovascular

• Common (1% to 10%): Hypotension
• Uncommon (0.1% to 1%): Bradycardia
• Very rare (less than 0.01%): Cardiac conduction abnormalities, heart block
• Frequency not reported: Acute congestive heart failure, acute hypertension, atrial fibrillation, atrioventricular (AV) block, cardiac arrest, edema, electrocardiogram QT prolonged, fatal cardiorespiratory arrest, hypertension, palpitation, possible AV block, shock, sinus arrest, supraventricular tachycardia, tachycardia, Torsade de Pointes, transient facial/upper body flushing, transient increase in blood pressure, ventricular fibrillation, ventricular tachycardia^[Ref]

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.

Acute hypertension has occurred in patients with pheochromocytoma.

Hypertension has occurred in patients with/without pheochromocytoma.^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Amenorrhea
• Rare (0.01% to 0.1%): Galactorrhea
• Frequency not reported: Breast enlargement, impotence, priapism, sexual dysfunction, urinary frequency, urinary incontinence^[Ref]

Impotence may be secondary to hyperprolactinemia.^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Hyperprolactinemia
• Frequency not reported: Endocrine disorders, gynecomastia, transient aldosterone elevation^[Ref]

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

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Frequency not reported: Anaphylactic reaction, anaphylactic shock, angioedema^[Ref]

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

Respiratory

• Rare (0.01% to 0.1%): Dyspnea, laryngospasm, stridor, upper airway obstruction
• Frequency not reported: Acute asthmatic symptoms, bronchospasm, laryngeal edema, respiratory failure, wheezing^[Ref]

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

Respiratory failure occurred secondary to dystonic reactions.^[Ref]

Hepatic

• Rare (0.01% to 0.1%): Altered liver function tests, hepatotoxicity, jaundice^[Ref]

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

Musculoskeletal

• Rare (0.01% to 0.1%): Rigidity
• Frequency not reported: Fluid retention, generalized muscle tone increase, increased creatinine phosphokinase (CPK), muscle rigidity, muscle spasms, torticollis, trismus^[Ref]

Hematologic

• Frequency not reported: Agranulocytosis, blood disorders, leukopenia, methemoglobinemia, neutropenia, sulfhemoglobinemia^[Ref]

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]

Dermatologic

• Frequency not reported: Angioneurotic edema, maculopapular rash, rash, urticaria^[Ref]

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

Ocular

• Frequency not reported: Extraocular muscle spasm, oculogyric crisis, visual disturbances^[Ref]

Metabolic

• Frequency not reported: Fluid retention, porphyria^[Ref]

Further information

Metozolv ODT side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer