65/100 · Elevated
Manufactured by Granules India Ltd
Moderate Safety Concerns with Methocarbamol Tablets
33,934 FDA adverse event reports analyzed
Last updated: 2026-05-12
METHOCARBAMOL TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Granules India Ltd. Based on analysis of 33,934 FDA adverse event reports, METHOCARBAMOL TABLETS has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for METHOCARBAMOL TABLETS include PAIN, FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHOCARBAMOL TABLETS.
Methocarbamol Tablets has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 33,934 adverse event reports for this medication, which is primarily manufactured by Granules India Ltd.
The most commonly reported adverse events include Pain, Fatigue, Nausea. Of classified reports, 62.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and fatigue are the most common reactions, indicating potential side effects.
Serious reactions such as chronic kidney disease and acute kidney injury are reported, warranting caution. Drug ineffectiveness and product use issues are frequent, suggesting variability in efficacy and misuse. Psychiatric symptoms like anxiety and depression are notable, indicating potential mental health impacts.
Patients taking Methocarbamol Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Methocarbamol tablets may interact with other drugs, particularly those affecting the central nervous system, and should be used with caution in patients with kidney disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Methocarbamol Tablets received a safety concern score of 65/100 (elevated concern). This is based on a 62.9% serious event ratio across 15,409 classified reports. The score accounts for 33,934 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 9,822, Male: 4,564, Unknown: 22. The most frequently reported age groups are age 58 (293 reports), age 60 (285 reports), age 50 (280 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 15,409 classified reports for METHOCARBAMOL TABLETS:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Methocarbamol tablets may interact with other drugs, particularly those affecting the central nervous system, and should be used with caution in patients with kidney disease.
If you are taking Methocarbamol Tablets, here are important things to know. The most commonly reported side effects include pain, fatigue, nausea, drug ineffective, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of kidney issues, such as changes in urination or swelling, and report them to your healthcare provider. Be aware of potential psychiatric symptoms and seek medical advice if they occur. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has not issued specific warnings for methocarbamol tablets, but patients should report any serious adverse events to their healthcare provider.
The FDA has received approximately 33,934 adverse event reports associated with Methocarbamol Tablets. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Methocarbamol Tablets include Pain, Fatigue, Nausea, Drug Ineffective, Headache. By volume, the top reported reactions are: Pain (1,128 reports), Fatigue (1,113 reports), Nausea (1,054 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Methocarbamol Tablets.
Out of 15,409 classified reports, 9,695 (62.9%) were classified as serious and 5,714 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Methocarbamol Tablets break down by patient sex as follows: Female: 9,822, Male: 4,564, Unknown: 22. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Methocarbamol Tablets adverse events are: age 58: 293 reports, age 60: 285 reports, age 50: 280 reports, age 61: 267 reports, age 59: 262 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Methocarbamol Tablets adverse event reports is Granules India Ltd. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Methocarbamol Tablets include: Fall, Diarrhoea, Dyspnoea, Off Label Use, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Methocarbamol Tablets to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Methocarbamol Tablets has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Pain and fatigue are the most common reactions, indicating potential side effects.
Key safety signals identified in Methocarbamol Tablets's adverse event data include: Chronic kidney disease and acute kidney injury are significant safety signals.. Drug ineffectiveness and product use issues are common, indicating potential misuse or dosing problems.. Psychiatric symptoms such as anxiety and depression are frequently reported, suggesting potential mental health risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Methocarbamol tablets may interact with other drugs, particularly those affecting the central nervous system, and should be used with caution in patients with kidney disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Methocarbamol Tablets.
Monitor for signs of kidney issues, such as changes in urination or swelling, and report them to your healthcare provider. Be aware of potential psychiatric symptoms and seek medical advice if they occur.
Methocarbamol Tablets has 33,934 adverse event reports on file with the FDA. Serious reactions such as chronic kidney disease and acute kidney injury are reported, warranting caution. The volume of reports for Methocarbamol Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for methocarbamol tablets, but patients should report any serious adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Granules India Ltd and compare their safety profiles:
The following drugs share commonly reported adverse reactions with METHOCARBAMOL TABLETS:
Drugs related to METHOCARBAMOL TABLETS based on therapeutic use, drug class, or shared indications: