What the label lists and what reports show
Metoclopramide side effects
Metoclopramide's FDA label: “The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude.” FAERS holds 76,710 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is extrapyramidal disorder (12,922 reports).
- Generic listed
- Boxed warning
Check it at the source: the metoclopramide FDA label on DailyMed (effective May 18, 2026, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of metoclopramide tablets?Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need to know about metoclopramide tablets?” • Other changes in muscle control and movement, such as: • Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions, and speech problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may cause trouble breathing. These spasms happen more often in adults less than 30 years of age who took higher doses of metoclopramide tablets. • Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson's Disease, your symptoms may become worse while you are taking metoclopramide tablets. […]
Source: FDA drug label, NDA017854 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective May 18, 2026 (SPL set 797aad80-0597-42f8-99d5-39de180c3b5a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the METOCLOPRAMIDE hydrochloride label published by Lupin Pharmaceuticals,Inc. of September 11, 2019; the label quoted above does not print one.
| Adverse Reaction | Metoclopramide Hydrochloride Orally Disintegrating TabletsN 1,3 (%) 2 | Metoclopramide tabletsN 1,4 (%) 2 |
|---|---|---|
| Nausea | 4 (4.2 %) | 4 (5.6 %) |
| Vomiting | 2 (2.1 %) | 1 (1.4 %) |
| Fatigue | 2 (2.1 %) | 2 (2.8 %) |
| Headache | 5 (5.2 %) | 3 (4.2 %) |
| Somnolence | 2 (2.1 %) | 2 (2.8 %) |
| Dizziness | 1 (1.0 %) | 3 (4.2 %) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 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. …
Source: FDA drug label, NDA017854 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective May 18, 2026 (SPL set 797aad80-0597-42f8-99d5-39de180c3b5a), via openFDA; the full label on DailyMed
What do FAERS reports show?
76,710 reports list metoclopramide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9,885 are coded as a death and 33,932 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Metoclopramide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions