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GIMOTI METOCLOPRAMIDE HYDROCHLORIDE 15 mg/.07mL Spray, 1 bottle

by Evoke Pharma, Inc. · 1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP
NDC 72089-0307-15
🏷️ FDA NDC (as labeled) 72089-307-15 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 72089-307-15
Product NDC 72089-307
11-digit billing NDC 72089030715
NCPDP billing unit ML — per mL (volume)
RxCUI 2380564, 2380570
UNII W1792A2RVD
Application # NDA209388
SPL Set ID 95269b1f-779c-4ca0-9f86-e74e677f9900
Established class (EPC) Dopamine-2 Receptor Antagonist
Mechanism of action Dopamine D2 Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-19
Route NASAL
Dosage form SPRAY
Substance METOCLOPRAMIDE HYDROCHLORIDE
GPI-14 52300020102080
GPI class Gimoti
GCN Seq No 081226
GCN 48272
HICL code 002148
Ingredient (HICL) Metoclopramide Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J9
Therapeutic class — intermediate (HIC2) Drugs Affecting Intestinal Motility
HIC3 code J9A
Therapeutic class — specific (HIC3) Intestinal Motility Stimulants
AHFS code 56:32.00.00
AHFS class Prokinetic Agents
FDB label name GIMOTI 15 MG NASAL SPRAY
FDB brand name Gimoti
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 72089-307-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72089-0307-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Dopamine-2 Receptor Antagonist class.

Pharmacologic class Dopamine-2 Receptor Antagonist
Drug family (ATC) Propulsives
How it works Dopamine D2 Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerEvoke Pharma, Inc.
Application holderQOL MEDICAL LLC
FDA applicationNDA209388 (NDA)
Labeler code72089
First marketedJun 2020
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GIMOTI 15 MG NASAL SPRAY Ingredient Metoclopramide Hcl
📗 Our plain-language guide HelloPharmacist
  • Diabetic gastroparesis slows stomach emptying, which can make oral medications less predictably absorbed — your stomach may not empty the pill efficiently or on schedule. Deliverin...
  • Why do I have to spray this medication in my nose instead of just swallowing a pill?
  • Before your very first dose from a new bottle, pump it into the air 10 times to prime it. Then place the tip just inside one nostril, tilt your head slightly forward so the tip aim...
  • The most serious risk is called tardive dyskinesia — uncontrolled, repetitive movements of the face, tongue, or body that can sometimes become permanent. It's rare, but the risk go...
📖 Read our full Metoclopramide Nasal Spray guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $234.05 $2,293.65 / 9.8 ml
Medicare drug plans payPart D · Q2 2026 $271.76 $2,663.24 / 9.8 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gimoti 15 mg/.07mLthis 72089-0307-15 Evoke 1 bottle — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
First FDA approval
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 19, 2020 RLD RS ⏳ ~12.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11020361 — method of use (U-2843)
US 12194009 — method of use (U-2843)
US 12194008 — method of use (U-2843)
US 8334281 — method of use (U-2843)
US 11628150 — method of use (U-2843)
US 12377064 — method of use (U-2843)
US 11813231 — method of use (U-2843)
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 11020361 ↗ Method of use U-2843 Dec 22, 2029
US 12194009 ↗ Method of use U-2843 Dec 22, 2029
US 12194008 ↗ Method of use U-2843 Dec 22, 2029
US 8334281 ↗ Method of use U-2843 May 16, 2030
US 11628150 ↗ Method of use U-2843 Dec 22, 2029
US 12377064 ↗ Method of use U-2843 Nov 17, 2038
US 11813231 ↗ Method of use U-2843 Dec 22, 2029
Common questions
Is there a generic version of GIMOTI 15 MG NASAL SPRAY?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for GIMOTI 15 MG NASAL SPRAY. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2038 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72089-0307-15, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
893
Units reimbursed last 4 qtrs
8.8K
Gross reimbursed last 4 qtrs
$2.05M
Avg / prescription
$2,293.81
Avg / unit
$234.06
Latest quarter Q4 2025
211Rx
Fee-for-service vs managed care ⓘ
20% FFS 80% MCO
Fee-for-service · 176 Rx Managed care · 717 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,411 units · 14.1 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 255 units · 3.7 per 100k residents IN Ohio: 1,901 units · 16.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 167 units · 0.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 696 units · 15.4 per 100k residents KY West Virginia: no data reported WV Virginia: 157 units · 1.8 per 100k residents VA Maryland: no data reported MD Connecticut: 1,294 units · 35.8 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 147 units · 2.1 per 100k residents TN North Carolina: 284 units · 2.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,029 units · 22.5 per 100k residents LA Mississippi: no data reported MS Alabama: 118 units · 2.3 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,117 units · 3.7 per 100k residents TX Florida: 176 units · 0.8 per 100k residents FL
Units reimbursed · per 100k residents
0.435.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 35.8 /100k
2 Louisiana 22.5 /100k
3 Ohio 16.1 /100k
4 Kentucky 15.4 /100k
5 Michigan 14.1 /100k
6 Indiana 3.7 /100k
7 Texas 3.7 /100k
8 North Carolina 2.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gimoti — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gimoti. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.39M
Claims incl. refills
574
Beneficiaries
335
Spend / beneficiary
$4,162.65
Spend / claim
$2,429.42
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for GIMOTI (this brand).

Top reported reactions

Tardive Dyskinesia2,414
Extrapyramidal Disorder1,094
Nausea806
Incorrect Drug Administration Duration691
Diarrhoea494
Vomiting476
Nervous System Disorder404

Age at onset

Neonate13
Infant1
Child14
Adolescent8
Adult717
Elderly554

Reporter sex

8,881 reports

Serious outcomes

Hospitalization3,348
Death1,087
Disabling760
Life-threatening577
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 905 259
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72089-0307-15 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP 2020-06-19 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72089-307-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72089-0307-15, written without dashes as 72089030715. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72089-0307-15, the first segment (72089) is the labeler code FDA assigned to Evoke Pharma, Inc.; the middle segment (0307) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Evoke Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Evoke Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

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 [see Warnings and Precautions ( 5.1 )] . 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 [see Warnings and Precautions ( 5.1 )] . 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 [see Warnings and Precautions ( 5.1 )] . WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . 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. ( 5.1 ) GIMOTI is contraindicated in patients with a history of TD. ( 4 ) Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment.

( 2.2 , 5.1 ) Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD. ( 5.1 ) 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.

( 5.1 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. GIMOTI is a dopamine-2 (D 2 ) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.

( 1 , 8.4 ) moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. ( 1 , 5.9 , 7.1 ) Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions [see Warnings and Precautions ( 5.9 )].

Limitations of Use : GIMOTI is not recommended for use in: pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions [see Warnings and Precautions ( 5.9 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administration See the full prescribing information for complete information on administration. ( 2.1 ) Recommended Dosage Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily). ( 2.2 ) Adults 65 years of age and older: GIMOTI is not recommended in geriatric patients as initial therapy.

Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). ( 2.2 , 8.5 )

2.1Important Administration and Storage Instructions One spray in one nostril administers the appropriate dose. Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose.

Close the other nostril with the other index finger. Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril.

Remove spray pump nozzle tip from nostril and exhale slowly through the mouth. Wipe the spray nozzle with a clean tissue. Missed or Incomplete Doses If uncertain that the spray entered the nose, do not repeat the dose.

Take the next dose at the scheduled time. If a dose is missed, take the next dose of GIMOTI at the regularly scheduled time. Do not make up for the missed dose or double the next dose.

Storage Discard GIMOTI 4 weeks after opening even if the bottle contains unused drug.

2.2Recommended Dosage Adults Less Than 65 Years of Age The recommended dosage of GIMOTI for the treatment of acute and recurrent diabetic gastroparesis in adults is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of four times daily). Adults 65 Years of Age and Older Elderly patients may be more sensitive to the adverse effects of metoclopramide and require a lower starting dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is not recommended in geriatric patients as initial therapy.

Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily). Treatment Duration Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Avoid treatment with metoclopramide, including GIMOTI, for longer than 12 weeks.

If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] .

2.1Important Administration and Storage Instructions One spray in one nostril administers the appropriate dose. Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose.

Close the other nostril with the other index finger. Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril.

Remove spray pump nozzle tip from nostril and exhale slowly through the mouth. Wipe the spray nozzle with a clean tissue. Missed or Incomplete Doses If uncertain that the spray entered the nose, do not repeat the dose.

Take the next dose at the scheduled time. If a dose is missed, take the next dose of G…

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal Spray: 15 mg of metoclopramide in each 70 microliter spray. GIMOTI is an aqueous solution supplied in an amber glass bottle fitted with a metered spray pump attachment. Nasal Spray: 15 mg metoclopramide in each 70 microliter spray. ( 3 )

⛔ Contraindications 160 words ▾

4 CONTRAINDICATIONS GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions ( 5.1 , 5.2) ] . When 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 [see Warnings and Precautions ( 5.5 )] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions ( 6 )] .

In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions ( 6 )] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hypersensitivity to metoclopramide ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's disease. If symptoms occur, discontinue GIMOTI and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 )

5.1Tardive Dyskinesia Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Metoclopramide, including GIMOTI, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD because it may mask the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown.

TD may remit, partially or completely, if GIMOTI treatment is discontinued. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased in elderly patients, especially in elderly women [see Use in Specific Populations ( 8.5 )] , and in patients with diabetes mellitus.

Prevention, Mitigation, and Monitoring for TD GIMOTI is contraindicated in patients with a history of TD. Avoid use of GIMOTI in patients receiving concomitant antipsychotics due to the potential additive effects of TD [see Drug Interactions ( 7.1 )] . GIMOTI is not recommended in geriatric patients as initial therapy [see Dosage and Administration ( 2.2 )] .

Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue GIMOTI immediately in patients who develop signs and 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. If patients have continued TD symptoms, consider TD treatment.

5.2Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue GIMOTI. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with oral metoclopramide dosages of 30 mg to 40 mg daily.

Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (GIMOTI is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting metoclopramide.

Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions.

Avoid GIMOTI in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided within 2 to 3 months after discontinuation of metoclopramide.

Avoid GIMOTI in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. If treatment is unavoidable, use GIMOTI for the shortest duration of treatment and periodically reassess the need fo…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal symptoms [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression [see Warnings and Precautions ( 5.4 )] Hypertension [see Warnings and Precautions ( 5.5 )] Fluid retention [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Effects on the ability to drive and operate machinery [see Warnings and Precautions ( 5.8 )] The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The safety of GIMOTI was evaluated in clinical trials of patients with gastroparesis and established in clinical trials of oral metoclopramide. Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Evoke Pharma, Inc. at 1-833-4-GIMOTI (1-833-444-6684), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Safety of GIMOTI In a randomized, placebo-controlled clinical trial of 190 male and female patients of GIMOTI 14 mg, a slightly lower than recommended dosage, administered nasally four times daily for 4 weeks, dysgeusia was the most commonly reported adverse reaction (15% of GIMOTI-treated patients and 4% of placebo-treated patients). Other adverse reactions were similar to those reported for oral metoclopramide.

Safety of Oral Metoclopramide The most common adverse reactions (in approximately 10% of patients receiving the recommended oral metoclopramide dosage of 10 mg four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration. Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.

Central Nervous System Disorders Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms Convulsive seizures Hallucinations Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received metoclopramide orally 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently. Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents) Endocrine Disorders : Fluid retention secondary to transient elevation of aldosterone, galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Cardiovascular Disorders : Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention Gastrointestinal Disorders : Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders : Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential Renal and Urinary Disorders : Urinary frequency, urinary incontinence Hematologic Disorders : Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia Hypersensitivity Reactions : Bronchospasm (especially in patients with a history of asthma), urticaria, rash, angioedema, including glossal or laryngeal edema Eye Disorders : Visual disturbances Metabolism Disorders : Porphyria

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Antipsychotics : Potential for additive effects, including TD, EPS, and NMS; avoid concomitant use. ( 7.1 ) Central nervous system (CNS) depressants : Increased risk of CNS depression. Avoid concomitant use and monitor for adverse reactions. ( 7.1 ) Monoamine oxidase (MAO) inhibitors : Increased risk of hypertension; avoid concomitant use. ( 5.5 , 7.1 ) Additional drug interactions : See Full Prescribing Information. ( 7.1 , 7.2 )

7.1Effects of Other Drugs on Metoclopramide Table 1 displays the effects of other drugs on metoclopramide. Table 1. Effects of Other Drugs on Metoclopramide Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS).

Intervention Avoid concomitant use [see Warnings and Precautions ( 5.1 , 5.2 , 5.3) ]. Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology ( 12.3 )]. Intervention Use of GIMOTI is not recommended [see Warnings and Precautions ( 5.9 )] .

Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [see Warnings and Precautions ( 5.5 )]. Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [see Warnings and Precautions ( 5.8 )].

Intervention Avoid GIMOTI or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates, and anxiolytics Drugs that Impair Gastrointestinal Motility Clinical Impact Potential for decreased effect of metoclopramide due to opposing effects on gastrointestinal motility. Intervention Monitor for reduced effect on gastrointestinal motility.

Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine

7.2Effects of Metoclopramide on Other Drugs Table 2 displays the effects of metoclopramide on other drugs. Table 2. Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine.

Potential exacerbation of symptoms (e.g., parkinsonian symptoms). Intervention Avoid concomitant use [see Warnings and Precautions ( 5.2 )] . Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine Succinylcholine, Mivacurium Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.

Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade Drugs with Absorption Altered due to Increased Gastrointestinal Motility Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure. Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension Interaction does not apply to posaconazole delayed-release tablet. , fosfomycin) : Monitor for reduced therapeutic effect of the interacting drug.

For digoxin, monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine) : Monitor therapeutic drug concentrations and adjust the dose as needed. See prescribing information fo…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report a consistent pattern or a consistently increased risk of adverse pregnancy-related outcomes with oral use of metoclopramide during pregnancy. However, available data from a case report of GIMOTI use in pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery (see Clinical Considerations ).

In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions ( 5.1 , 5.2) , Use in Specific Populations ( 8.4 )] .

Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to metoclopramide was observed.

8.2Lactation Risk Summary There are no data on the presence of metoclopramide in human milk following nasal administration; however, published data report the presence of metoclopramide in human milk in variable amounts following oral administration (see Data ) . Systemic exposure following nasal administration of GIMOTI 15 mg is expected to be similar to oral administration of metoclopramide 10 mg [see Clinical Pharmacology ( 12.3 )] . Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation (see Clinical Considerations ) .

Metoclopramide elevates prolactin levels [see Warnings and Precautions ( 5.7 )] ; however, the published data are not adequate to support drug effects on milk production. 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. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions ( 5.1 , 5.2) , Use in Specific Populations ( 8.4 )] .

Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted oral dose. In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.

8.4Pediatric Use Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of GIMOTI in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms asso…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report a consistent pattern or a consistently increased risk of adverse pregnancy-related outcomes with oral use of metoclopramide during pregnancy. However, available data from a case report of GIMOTI use in pregnancy is insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery (see Clinical Considerations ).

In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions ( 5.1 , 5.2) , Use in Specific Populations ( 8.4 )] .

Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to metoclopramide was observed.

🧒 Pediatric Use 114 words ▾

8.4Pediatric Use Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of GIMOTI in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [see Indications and Usage ( 1 ), Warnings and Precautions ( 5.1 , 5.2) ] .

In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [see Use in Specific Populations ( 8.8 )] .

🧓 Geriatric Use 121 words ▾

8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Elderly patients are more likely to have decreased renal function and may be more sensitive to the adverse effects of metoclopramide, especially elderly women, and require a lower starting dosage. GIMOTI is not recommended in geriatric patients as initial therapy.

Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to GIMOTI [see Dosage and Administration ( 2.2 )].

🆘 Overdosage 125 words ▾

10 OVERDOSAGE Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions ( 5.1 , 5.2 , 5.3) ]. There are no specific antidotes for metoclopramide overdosage.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage . Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal.

Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.

The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.

It has little, if any, effect on the motility of the colon or gallbladder.

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, double-blind, positive-controlled thorough ECG study in 48 healthy subjects, a single administration of 80 mg metoclopramide nasal spray (approximately 5 times the recommended GIMOTI dose) had no effect on the QTc interval.

12.3Pharmacokinetics Absorption The absolute bioavailability of metoclopramide following nasal administration of 10 mg metoclopramide is 47% in healthy subjects compared to intravenous injection of metoclopramide 10 mg. The systemic absorption after nasal administration is lower than that after oral administration given the same dose. Following nasal administration of GIMOTI 15 mg in healthy subjects, the systemic exposure (C max and AUC) to metoclopramide and the time to reach C max (T max ) were similar to orally administered 10 mg metoclopramide tablet.

After single nasal administration of metoclopramide at doses ranging from 10 mg to 80 mg in healthy subjects, there was a dose-proportional increase in the mean values for C max and AUC. The pharmacokinetic parameters of metoclopramide in healthy subjects following a single nasal administration of GIMOTI 15 mg are summarized in Table 3. Table 3.

Summary of Metoclopramide Pharmacokinetic Parameters in Healthy Subjects after a Single Nasal Administration of GIMOTI 15 mg Parameter Arithmetic mean (SD) except t max for which the median (range) is reported. GIMOTI 15 mg N 94 C max (ng/mL) 41.0 (19.9) t max (h) 1.25 (0.50 – 3.50) AUC 0-t (ng∙h/mL) 349 (174.7) AUC 0-inf (ng∙h/mL) N = 93 367 (184.8) t 1/2 (h) 8.1 (2.0) Distribution Metoclopramide is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about

3.5L/kg), which suggests extensive distribution of drug to the tissues. Elimination The mean elimination half-life in individuals with normal renal function is approximately 8 hours for administration with GIMOTI 15 mg. Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as glucuronide and sulfate conjugation reactions in the liver.

Monodeethylmetoclopramide, a major oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic variability [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.9 )] . Excretion: Approximately 85% of the radioactivity of an orally administered dose appeared in the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and 22% of the dose, respectively, was recovered as free metoclopramide in urine within 36 hours.

Specific Populations Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease [ESRD] requiring dialysis), the systemic exposure (AUC) of metoclopramide following oral administration in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in sub…

🧬 Mechanism of Action 133 words ▾

12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.

The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.

It has little, if any, effect on the motility of the colon or gallbladder.

📦 How Supplied / Storage and Handling 122 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING GIMOTI (metoclopramide) nasal spray is supplied as a solution of metoclopramide in a 10 mL Type 1 amber glass bottle fitted with a metered spray pump attachment, a protective cap, and a safety clip. Each box of GIMOTI (NDC 72089-307-15) contains 1 bottle, with FDA-approved Patient Labeling (see Instructions for Use for proper actuation of the device). Each actuation delivers 15 mg of metoclopramide.

Each bottle contains 9.8 mL which is sufficient for 4 weeks of 4 times a day use. Store at 20°C to 25°C (68°F to 77°F) excursions permitted 15°C to 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ]. Discard GIMOTI 4 weeks after opening even if the bottle contains unused medicine.

📦 Storage and Handling 36 words ▾

Store at 20°C to 25°C (68°F to 77°F) excursions permitted 15°C to 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ]. Discard GIMOTI 4 weeks after opening even if the bottle contains unused medicine.

📋 Description 136 words ▾

11 DESCRIPTION Metoclopramide hydrochloride, the active ingredient in GIMOTI, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino­-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.

The molecular formula is C 14 H 22 ClN 3 O 2 ∙HCl∙H 2 O. Its molecular weight is 354.3. The structural formula is: GIMOTI (metoclopramide) nasal spray is for nasal administration.

The product is supplied as an aqueous solution with a pH of 5.5 ± 0.5 in a 10 mL amber glass vial fitted with a metered spray pump attachment. Each unit contains 9.8 mL. Each 70 microliter spray contains 15 mg metoclopramide, equivalent to 17.73 mg of metoclopramide hydrochloride.

Inactive ingredients consist of benzalkonium chloride, citric acid monohydrate, edetate disodium dihydrate, purified water, sodium citrate dihydrate, and sorbitol. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions Tardive Dyskinesia and/or other Extrapyramidal Reactions Inform patients that GIMOTI may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately discontinue GIMOTI and contact their healthcare provider if symptoms occur [see Warnings and Precautions ( 5.1 , 5.2 )] .

Neuroleptic Malignant Syndrome Inform patients that serious neuroleptic malignant syndrome (NMS) has been reported in association with concomitant treatment with another drug associated with NMS. Advise patients to report all prescription and over-the-counter medications to the healthcare provider. Instruct patients to immediately discontinue GIMOTI and seek medical attention if symptoms occur [see Warnings and Precautions ( 5.3 )] Depression and/or Possible Suicidal Ideation Inform patients that symptoms of new onset or worsening depression as well as suicidal ideation have been reported in patients taking metoclopramide.

Instruct patients to immediately discontinue GIMOTI and contact their healthcare provider if any of these symptoms occur [see Warnings and Precautions ( 5.4 )] Drug Interactions Inform the patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions ( 7.1 , 7.2 )] . Explain that the prescriber of any other medication must be made aware that the patient is taking GIMOTI.

Effects on the Ability to Drive and Operate Machinery Inform the patient or their caregiver that GIMOTI may cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [see Warnings and Precautions ( 5.8 )] . Administration Instructions [see Dosage and Administration ( 2.1 )] Advise the patients or their caregiver to read the Instructions for Use on how to appropriately administer GIMOTI: One spray in one nostril administers the appropriate dose.

Before administering the first dose from a bottle, prime the pump by pressing down on the finger flange and releasing 10 sprays in the air. Place the spray nozzle tip under one nostril and lean the head slightly forward so the tip of spray nozzle is aimed away from the septum and toward the back of the nose. Close the other nostril with the other index finger.

Move spray pump upwards so the tip of the nozzle is in the nostril. To ensure a full dose, hold the bottle upright while pressing down firmly and completely on finger flange and release while inhaling slowly through the open nostril. Remove spray pump nozzle tip from nostril and exhale slowly through the mouth.

Wipe the spray nozzle with a clean tissue. Missed or Incomplete Doses If uncertain that the spray entered the nose, do not repeat the dose. Take the next dose at the scheduled time.

If a dose is missed, take the next dose of GIMOTI at the regularly scheduled time. Do not make up for the missed dose or double the next dose.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: February 2026 Medication Guide GIMOTI™ (jye-MOH-tee) (metoclopramide) nasal spray Read this Medication Guide before you start taking GIMOTI and each time you get a refill. There may be new information.

If you take another product that contains metoclopramide (such as REGLAN tablets, REGLAN injection, metoclopramide orally disintegrating tablets [ODT], or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about GIMOTI? GIMOTI can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face or tongue and sometimes in the arms or legs.

You cannot control these movements. These symptoms may not go away even after stopping GIMOTI. Your chances for getting tardive dyskinesia increase: the longer you take GIMOTI and the more GIMOTI you take.

Use for the shortest time needed. You should not take products containing metoclopramide (including GIMOTI) for more than 12 weeks. If you require treatment for longer than 12 weeks, your healthcare provider should frequently monitor you for signs and symptoms of tardive dyskinesia if you are older, especially if you are an older woman. because you have diabetes.

It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take GIMOTI. Stop taking GIMOTI and call your healthcare provider right away if you get movements you cannot stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs Your healthcare provider may decide not to continue treatment with GIMOTI if you develop signs or symptoms of tardive dyskinesia. See the section "What are the possible side effects of GIMOTI?" for more information about side effects.

What is GIMOTI? GIMOTI is a prescription medicine used in adults to relieve the symptoms of slow stomach emptying in people with diabetes. GIMOTI is not recommended for use in people who: have kidney or liver problems. have been told that an enzyme in their body, called CYP2D6, breaks down (metabolizes) certain medicines in the body too slowly. are also taking medicine called CYP2D6 inhibitors, which slows how fast the body breaks down (metabolizes) certain medicines.

GIMOTI is not recommended for use in children. It is not known if GIMOTI is safe and effective in children. Do not take GIMOTI if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking GIMOTI or a medicine that works like GIMOTI. have stomach or intestine problems that could get worse with GIMOTI, such as bleeding, blockage, or a tear in the stomach or bowel wall. have a type of tumor that can cause high blood pressure, such as pheochromocytoma. have epilepsy (seizures).

GIMOTI can increase your chance for seizures and make them worse. are allergic to metoclopramide. GIMOTI can cause serious allergic reactions. Stop taking GIMOTI right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes, or face trouble swallowing or breathing skin rash, hives, sores in your mouth, or skin blisters Before taking GIMOTI, tell your healthcare provider about all of your medical conditions, including if you: had problems controlling your muscle movements after taking any medicine. have Parkinson’s disease. have or had depression or mental illness. have kidney or liver disease. have heart failure or heart rhythm problems. have high blood pressure. drink alcohol. have diabetes.

Your dose of insulin may need to be changed. are pregnant or plan to become…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.