Drug Safety-related Labeling Changes (SrLC)

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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.

REGLAN (NDA-017854)

(METOCLOPRAMIDE HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/09/2026 (SUPPL-71)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined:

WARNING: TARDIVE DYSKINESIA

Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1)].
Reglan is contraindicated in patients with a history of TD.
Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment.
Immediately discontinue Reglan in patients who develop signs or symptoms of TD
[see Warnings and Precautions (5.1)].
In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of Reglan treatment is 12 weeks [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including Reglan tablets, 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 Dyskinesia

Additions and/or revisions underlined:

Metoclopramide, including Reglan, 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 Reglan, 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 Reglan treatment is discontinued.

In patients treated with metoclopramide, including Reglan, 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

Reglan is contraindicated in patients with a history of TD.
Avoid use of Reglan in patients receiving other drugs that are likely to cause TD (e.g.,concomitant antipsychotics due to the potential additive effects of TD [see Drug Interactions (7.1)].
Reduce the Reglan dosage in the elderly [see Dosage and Administration (2.1, 2.2)].
Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment.
Immediately discontinue Reglan in patients who develop signs and symptoms of TD.
In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of treatment is 12 weeks [see Dosage and Administration (2.2)].
In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including Reglan tablets, 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.

5.2 Other Extrapyramidal Symptoms

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 Reglan. Avoid Reglan 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 Reglan 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 (2.1, 2.2)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Tardive Dyskinesia and/or other Extrapyramidal Reactions

Inform patients that Reglan may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately discontinue Reglan 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 Reglan 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 Reglan and contact their healthcare provider if any of these symptoms occur [see Warnings and Precautions (5.4)].

Drug Interactions

…

Effects on the Ability to Drive and Operate Machinery

…

MEDICATION GUIDE

Additions and/or revisions, please refer to label for complete information.

08/29/2017 (SUPPL-62)

Approved Drug Label (PDF)

Boxed Warning

PLR conversion; newly added information as below:

WARNING: TARDIVE DYSKINESIA

Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
Discontinue Reglan in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Reglan is stopped.
Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

4 Contraindications

PLR conversion; revised as below:

In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
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.
Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
In patients with epilepsy. Reglan may increase the frequency and severity of seizures.
In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.

5 Warnings and Precautions

PLR conversion; subsections as below – please refer to label for more information:

5.1 Tardive Dyskinesia

5.2 Other Extrapyramidal Symptoms

5.3 Neuroleptic Malignant Syndrome

5.4 Depression

5.5 Hypertension

5.6 Fluid Retention

5.7 Hyperprolactinemia

5.8 Effects pm the Ability to Drive and Operate Machinery

6 Adverse Reactions

PLR conversion; as below:

The following adverse reactions are described, or described in greater detail, in other sections of the labeling:

Tardive dyskinesia
Other extrapyramidal effects
Neuroleptic malignant syndrome
Depression
Hypertension
Fluid retention
Hyperprolactinemia

Effects on the ability to drive and operate machinery

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 most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide 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 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

7 Drug Interactions

7.1 Effects of Other Drugs on Metoclopramide

Table 3 displays the effects of other drugs on metoclopramide. See label for complete information.

7.2 Effects of Metoclopramide on Other Drugs

Table 4 displays the effects of metoclopramide on other drugs. See label for complete information.

8 Use in Specific Populations

PLLR conversion; please see label for complete information.

8.1 Pregnancy

8.2 Lactation

PLR conversion; please see label for complete information.

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 NADH-Cytochrome b5 Reductase Deficiency

8.9 CYP2D6 Poor Metabolizers

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

PLR conversion; newly added section, as below:

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients or their caregivers that Reglan can cause serious adverse reactions. Instruct patients to discontinue Reglan and contact a healthcare provider immediately if the following serious reactions occur:

Tardive dyskinesia and other extrapyramidal reactions
Neuroleptic malignant syndrome
Depression and/or possible suicidal ideation

Inform 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. Explain that the prescriber of any other medication must be made aware that the patient is taking Reglan.

Inform patients or their caregivers that Reglan can 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.