56/100 · Moderate
Manufactured by Boiron
Garlic Adverse Events: Moderate Safety Concerns with Common Mild Reactions
10,017 FDA adverse event reports analyzed
Last updated: 2026-05-12
GARLIC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boiron. Based on analysis of 10,017 FDA adverse event reports, GARLIC has a safety score of 56 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 GARLIC include FATIGUE, NAUSEA, DIARRHOEA, HEADACHE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GARLIC.
Garlic has a safety concern score of 56 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 10,017 adverse event reports for this medication, which is primarily manufactured by Boiron.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 54.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported reactions are mild to moderate in severity.
Fatigue, nausea, and diarrhea are the most common reactions. Serious reactions, such as death and pneumonia, are reported but less frequent. Age distribution shows a higher number of reports from older adults.
Patients taking Garlic should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Garlic may interact with blood pressure medications and should be used with caution in patients with hypertension. It can also affect blood clotting and should be monitored in patients on anticoagulants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Garlic received a safety concern score of 56/100 (elevated concern). This is based on a 54.2% serious event ratio across 4,208 classified reports. The score accounts for 10,017 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: 2,431, Male: 1,627, Unknown: 2. The most frequently reported age groups are age 71 (101 reports), age 69 (89 reports), age 72 (89 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 4,208 classified reports for GARLIC:
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.
Garlic may interact with blood pressure medications and should be used with caution in patients with hypertension. It can also affect blood clotting and should be monitored in patients on anticoagulants.
If you are taking Garlic, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, headache, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting garlic supplements, especially if you have underlying health conditions or are taking other medications. Monitor for any unusual symptoms and discontinue use if severe reactions 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 continues to monitor garlic supplements for safety. Consumers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 10,017 adverse event reports associated with Garlic. 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 Garlic include Fatigue, Nausea, Diarrhoea, Headache, Dizziness. By volume, the top reported reactions are: Fatigue (421 reports), Nausea (315 reports), Diarrhoea (279 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Garlic.
Out of 4,208 classified reports, 2,280 (54.2%) were classified as serious and 1,928 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 Garlic break down by patient sex as follows: Female: 2,431, Male: 1,627, Unknown: 2. 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 Garlic adverse events are: age 71: 101 reports, age 69: 89 reports, age 72: 89 reports, age 70: 86 reports, age 65: 83 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 Garlic adverse event reports is Boiron. 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 Garlic include: Pain, Dyspnoea, Drug Ineffective, Arthralgia, Pain In Extremity. 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 Garlic 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.
Garlic has a safety concern score of 56 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. Most reported reactions are mild to moderate in severity.
Key safety signals identified in Garlic's adverse event data include: High frequency of gastrointestinal reactions like nausea and diarrhea.. Multiple reports of cardiovascular issues including chest pain and palpitations.. Significant number of reports related to respiratory issues such as cough and pneumonia.. Several cases of neurological symptoms including dizziness and headache.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Garlic may interact with blood pressure medications and should be used with caution in patients with hypertension. It can also affect blood clotting and should be monitored in patients on anticoagulants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Garlic.
Consult a healthcare provider before starting garlic supplements, especially if you have underlying health conditions or are taking other medications. Monitor for any unusual symptoms and discontinue use if severe reactions occur.
Garlic has 10,017 adverse event reports on file with the FDA. Fatigue, nausea, and diarrhea are the most common reactions. The volume of reports for Garlic reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor garlic supplements for safety. Consumers should report any 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.
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