GIMOTI®’s tolerability and safety profile
Adverse events from the GIMOTI® clinical development program1
Others that were reported with GIMOTI® treatment at a frequency of ≤ 2% included dizziness (Placebo group) and somnolence.2
There was no evidence that changing the route of administration for metoclopramide from oral to nasal introduced any new safety issues or increased the incidence of serious CNS events.3
Risk of tardive dyskinesia
Tardive dyskinesia (TD) has been observed with dopamine receptor antagonists, including metoclopramide.3,4
The 2022 American College of Gastroenterology clinical guideline for gastroparesis states that the risk of TD from metoclopramide use is likely <1%.5
- Monitor patients closely, and discontinue GIMOTI® in patients who develop signs or symptoms of TD3
- If patients cannot tolerate metoclopramide due to side effects, they should not use GIMOTI®
- Patients at higher risk of TD include those who are at least 65 years old, have liver or kidney failure, or are taking a concomitant drug therapy that may also cause TD, such as antipsychotic medications4
- It is important to balance the potential risk and frequency of TD with the daily benefits GIMOTI® may provide
Other AEs that may be confused with TD
Some patients may experience movement disorders typically within 2-3 months after stopping GIMOTI® that seem like TD but are in fact acute extrapyramidal symptoms (EPS). EPS typically resolve spontaneously, while TD is a chronic condition that develops after long-term administration of dopamine receptor blocking agents.6,7
In the GIMOTI® Phase 3 clinical trial, no treatment-emergent adverse event (TEAE) suggestive of EPS was reported in >2% of subjects taking nasal metoclopramide (10 mg) or placebo.1
(n=103) (n, %)
This was a double-blind (1:1), placebo controlled, parallel-group, 28-day study of 205 patients. The most common nervous system TEAE was headache.1
Metoclopramide can cause TD, a serious movement disorder that is often irreversible.3
- Metoclopramide, including GIMOTI®, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI®, the risk of developing TD increases with duration of treatment and total cumulative dosage.
- GIMOTI® is contraindicated in patients with a history of TD.
- Use GIMOTI® for the shortest duration of treatment and periodically reassess the need for continued treatment.
- Immediately discontinue GIMOTI® in patients who develop signs or symptoms of TD.
- Avoid a total duration of treatment with metoclopramide products, including GIMOTI®, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD.
Monitor patients closely and discontinue GIMOTI® in patients who develop signs or symptoms of TD.3
- In some patients, symptoms may lessen or resolve after metoclopramide is stopped
If patients cannot tolerate metoclopramide due to side effects, they should not use GIMOTI®.
References: 1. Data on file. QOL Medical, LLC. 2. McCallum RW, Parkman HP, Fass R, Bhandari BR, Carlson MR, Buck RD. Metoclopramide nasal spray in women with symptomatic diabetic gastroparesis: a randomized, double-blind, placebo-controlled phase 3 study. Clin Gastroenterol Hepatol. Published online November 2, 2023. doi:10.1016/j.cgh.2023.10.022 3. Gimoti® (metoclopramide) nasal spray. [prescribing information]. Vero Beach, FL: QOL Medical, LLC. 2026. 4. McCallum RW, Parkman HP, Nguyen LA, Wright BA, Kalas MA, Quesenberry C, Nathan R, Shokoohi M, Donders J, Kunkel DC. Revisiting the Incidence of Tardive Dyskinesia With Oral Metoclopramide Use: A Real-World Epidemiology Study (2011-2020). Neurogastroenterol Motil. 2026 Jan;38(1):e70206. doi: 10.1111/nmo.70206. PMID: 41588797. 5. Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010 Jan;31(1):11-9. doi: 10.1111/ 6. D'Souza RS, Aslam SP, Hooten WM. Extrapyramidal Side Effects. [Updated 2025 Jan 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534115/ 7. Solmi M, Radua J, Stubbs B, Ricca V, Moretti D, Busatta D, Carvalho AF, Dragioti E, Favaro A, Monteleone AM, Shin JI, Fusar-Poli P, Castellini G. Risk factors for eating disorders: an umbrella review of published meta-analyses. Braz J Psychiatry. 2021 May-Jun;43(3):314-323. doi: 10.1590/1516-4446-2020-1099. PMID: 32997075; PMCID: PMC8136381.
Indication and Important Safety Information
INDICATION
Gimoti® (metoclopramide) nasal spray is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use
GIMOTI® is not recommended for use in pediatric patients, in patients with moderate or severe hepatic impairment, in patients with moderate or severe renal impairment, or in patients concurrently using strong CYP2D6 inhibitors.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: TARDIVE DYSKINESIA
- Metoclopramide, including GIMOTI®, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI®, the risk of developing TD increases with duration of treatment and total cumulative dosage.
- GIMOTI® is contraindicated in patients with a history of TD.
- Use GIMOTI® for the shortest duration of treatment and periodically reassess the need for continued treatment.
- Immediately discontinue GIMOTI® in patients who develop signs or symptoms of TD.
- Avoid a total duration of treatment with metoclopramide products, including GIMOTI®, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD.
CONTRAINDICATIONS
GIMOTI® is contraindicated in patients with a history of TD or a dystonic reaction to metoclopramide; when the stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation); in patients with pheochromocytoma or other catecholamine-releasing paragangliomas (metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor); in patients with epilepsy (metoclopramide may increase the frequency and severity of seizures); in patients with hypersensitivity to metoclopramide (reactions have included laryngeal and glossal angioedema and bronchospasm).
WARNING AND PRECAUTIONS
TARDIVE DYSKINESIA (TD): Metoclopramide, including GIMOTI®, can cause TD, a syndrome of potentially irreversible involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. The risk of developing TD and the likelihood that TD will become irreversible increases with the duration of treatment and the total cumulative dosage. The risk of developing TD is increased in the elderly, especially elderly women, and in patients with diabetes mellitus. Due to the risk of developing TD, avoid a total duration of treatment with metoclopramide products, including GIMOTI®, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. GIMOTI® is not recommended in geriatric patients as initial therapy. See full Prescribing Information for switching geriatric patients on a stable dose of an alternative metoclopramide product to GIMOTI®.
Other extrapyramidal symptoms (EPS): In addition to TD, metoclopramide may cause other EPS, parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue GIMOTI®.
Neuroleptic malignant syndrome (NMS): Metoclopramide may cause a potentially fatal symptom complex called NMS. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and manifestations of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such symptoms should be evaluated immediately. Avoid GIMOTI® in patients receiving other drugs associated with NMS, including typical and atypical antipsychotics.
Depression: Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal ideation and suicide. Avoid GIMOTI® use in patients with a history of depression.
Hypertension: Metoclopramide may elevate blood pressure and should be avoided in patients with hypertension or in patients taking monoamine oxidase inhibitors (MAOIs). Discontinue GIMOTI® in any patient with a rapid rise in blood pressure.
Fluid retention: Because metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. Discontinue GIMOTI® if any of these adverse reactions occur.
Hyperprolactinemia: As with other dopamine D2 receptor antagonists, metoclopramide elevates prolactin levels and may suppress pituitary gonadotropin secretion. This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, including metoclopramide.
Effects on the ability to drive and operate machinery: Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid GIMOTI® or the interacting drug, depending on the importance of the drug to the patient.
ADVERSE REACTIONS
The most common adverse reactions in patients treated with GIMOTI® are dysgeusia, headache, and fatigue. In patients receiving an equivalent oral dose of metoclopramide, the most common adverse reactions were restlessness, drowsiness, fatigue, and lassitude. Adverse reactions involving the nervous system occurred after stopping oral metoclopramide, including dizziness, nervousness, and headaches.
DRUG INTERACTIONS
Avoid concomitant use with antipsychotics, MAOIs, and central nervous system (CNS) depressants. Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, paroxetine) is not recommended. Use with caution with dopaminergic agonists and drugs that increase dopamine concentration. Monitor for reduced therapeutic effect when used with drugs that may have opposing effects on gastrointestinal motility (e.g., antiperistaltics, anticholinergics, opiates). Monitor patients receiving GIMOTI® for increased blood glucose and adjust insulin dose regimen as needed.
USE IN SPECIFIC POPULATIONS
Pregnancy: Published studies do not report a consistent pattern or a consistently increased risk of pregnancy-related adverse outcomes with oral use of metoclopramide during pregnancy. There are potential risks to the neonate during delivery following exposure to metoclopramide in utero.
Lactation: Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GIMOTI® and any potential adverse effects on the breastfed child from GIMOTI® or from the underlying maternal condition.
Pediatric: Metoclopramide is not recommended for use in pediatric patients due to the risk of TD and other EPS as well as the risk of methemoglobinemia in neonates.
Geriatric: Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide, especially older women. GIMOTI® is not recommended as initial therapy.
Renal impairment: GIMOTI® is not recommended in patients with moderate and severe renal impairment.
Hepatic impairment: GIMOTI® is not recommended in patients with moderate or severe hepatic impairment.
NADH-cytochrome b5 reductase deficiency: Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia.
CYP2D6 poor metabolizers: GIMOTI® is not recommended in patients who are CYP2D6 poor metabolizers.
Please see complete Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.