Drug Safety-related Labeling Changes (SrLC)
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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
GIMOTI (NDA-209388)
(METOCLOPRAMIDE HYDROCHLORIDE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
02/09/2026 (SUPPL-4)
Boxed Warning
Additions and/or revisions underlined:
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)].
5 Warnings and Precautions
5.1 Tardive DyskinesiaAdditions and/or revisions underlined:
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.
Additions and/or revisions underlined:
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 for continued treatment. Routinely monitor for signs and symptoms of Parkinson’s disease [see Dosage and Administration (2.2)].
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
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
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)]
…
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)].
…
MEDICATION GUIDE
Additions and/or revisions, please refer to label for complete information.