74/100 · Elevated
Manufactured by Amneal Pharmaceuticals LLC
Folic Acid Adverse Events: Mostly Non-Serious but with Serious Concerns
773,571 FDA adverse event reports analyzed
Last updated: 2026-05-12
FOLIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 773,571 FDA adverse event reports, FOLIC ACID has a safety score of 74 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for FOLIC ACID include DRUG INEFFECTIVE, FATIGUE, PAIN, ARTHRALGIA, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FOLIC ACID.
Folic Acid has a safety concern score of 74 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 773,571 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Pain. Of classified reports, 74.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are non-serious, but serious adverse events account for a significant portion of reports.
Pain and fatigue are the most commonly reported symptoms, with a high volume of reports. There is a notable presence of serious respiratory and cardiovascular issues, indicating potential risks.
Patients taking Folic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Folic acid is generally well-tolerated, but caution is advised for off-label use and in cases where the drug is ineffective. Interactions with other medications are rare but should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Folic Acid received a safety concern score of 74/100 (elevated concern). This is based on a 74.1% serious event ratio across 241,389 classified reports. The score accounts for 773,571 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: 152,556, Male: 70,375, Unknown: 340. The most frequently reported age groups are age 65 (4,326 reports), age 64 (4,113 reports), age 59 (4,107 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 241,389 classified reports for FOLIC ACID:
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.
Folic acid is generally well-tolerated, but caution is advised for off-label use and in cases where the drug is ineffective. Interactions with other medications are rare but should be monitored.
If you are taking Folic Acid, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, pain, arthralgia, rheumatoid arthritis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and use only as directed by a healthcare provider. Report any serious adverse events to your healthcare provider immediately. 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 continues to monitor folic acid safety, particularly for serious adverse events. Healthcare providers should report any serious adverse events to the FDA's MedWatch program.
The FDA has received approximately 773,571 adverse event reports associated with Folic Acid. 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 Folic Acid include Drug Ineffective, Fatigue, Pain, Arthralgia, Rheumatoid Arthritis. By volume, the top reported reactions are: Drug Ineffective (24,761 reports), Fatigue (23,330 reports), Pain (23,054 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Folic Acid.
Out of 241,389 classified reports, 178,839 (74.1%) were classified as serious and 62,550 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 Folic Acid break down by patient sex as follows: Female: 152,556, Male: 70,375, Unknown: 340. 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 Folic Acid adverse events are: age 65: 4,326 reports, age 64: 4,113 reports, age 59: 4,107 reports, age 63: 4,101 reports, age 66: 4,006 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 Folic Acid adverse event reports is Amneal Pharmaceuticals Llc. 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 Folic Acid include: Off Label Use, Nausea, Headache, Diarrhoea, Rash. 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 Folic Acid 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.
Folic Acid has a safety concern score of 74 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. The majority of reported reactions are non-serious, but serious adverse events account for a significant portion of reports.
Key safety signals identified in Folic Acid's adverse event data include: Serious adverse events such as pneumonia, dyspnoea, and pericarditis are reported.. A high number of reports involve drug ineffectiveness and off-label use.. There are multiple reports of infections and gastrointestinal disorders.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Folic acid is generally well-tolerated, but caution is advised for off-label use and in cases where the drug is ineffective. Interactions with other medications are rare but should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Folic Acid.
Follow prescribed dosages and use only as directed by a healthcare provider. Report any serious adverse events to your healthcare provider immediately.
Folic Acid has 773,571 adverse event reports on file with the FDA. Pain and fatigue are the most commonly reported symptoms, with a high volume of reports. The volume of reports for Folic Acid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor folic acid safety, particularly for serious adverse events. Healthcare providers should report any serious adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Amneal Pharmaceuticals LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with FOLIC ACID:
Drugs related to FOLIC ACID based on therapeutic use, drug class, or shared indications: