65/100 · Elevated
Manufactured by IDO PHARM
Moderate Safety Concerns with Hyaluronic Acid Use
2,531 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYALURONIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by IDO PHARM. Based on analysis of 2,531 FDA adverse event reports, HYALURONIC ACID 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 HYALURONIC ACID include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, NAUSEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYALURONIC ACID.
Hyaluronic Acid 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 2,531 adverse event reports for this medication, which is primarily manufactured by Ido Pharm.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 59.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and pain are the most frequently reported side effects.
Serious adverse events, such as pneumonia and respiratory failure, are present but less common. The majority of reactions are non-serious, but the diversity of reactions indicates a complex safety profile.
Patients taking Hyaluronic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution should be exercised in patients with pre-existing conditions, as some reactions may exacerbate underlying health issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hyaluronic Acid received a safety concern score of 65/100 (elevated concern). This is based on a 59.6% serious event ratio across 1,080 classified reports. The score accounts for 2,531 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: 746, Male: 240. The most frequently reported age groups are age 52 (32 reports), age 62 (29 reports), age 64 (27 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,080 classified reports for HYALURONIC 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.
No specific drug interactions are noted, but caution should be exercised in patients with pre-existing conditions, as some reactions may exacerbate underlying health issues.
If you are taking Hyaluronic Acid, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, nausea, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for any unusual symptoms and report them to your healthcare provider. Follow the prescribed dosage and usage instructions carefully. 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 the safety of hyaluronic acid products, and updates will be provided as necessary.
The FDA has received approximately 2,531 adverse event reports associated with Hyaluronic 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 Hyaluronic Acid include Off Label Use, Drug Ineffective, Fatigue, Nausea, Pain. By volume, the top reported reactions are: Off Label Use (123 reports), Drug Ineffective (102 reports), Fatigue (97 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hyaluronic Acid.
Out of 1,080 classified reports, 644 (59.6%) were classified as serious and 436 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 Hyaluronic Acid break down by patient sex as follows: Female: 746, Male: 240. 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 Hyaluronic Acid adverse events are: age 52: 32 reports, age 62: 29 reports, age 64: 27 reports, age 67: 25 reports, age 63: 24 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 Hyaluronic Acid adverse event reports is Ido Pharm. 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 Hyaluronic Acid include: Arthralgia, Headache, Diarrhoea, Dizziness, Asthenia. 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 Hyaluronic 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.
Hyaluronic Acid 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. Fatigue, nausea, and pain are the most frequently reported side effects.
Key safety signals identified in Hyaluronic Acid's adverse event data include: Pain and fatigue are the most common side effects.. Serious reactions like pneumonia and respiratory failure have been reported.. A wide range of reactions, including cardiovascular and neurological issues, suggest a complex safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution should be exercised in patients with pre-existing conditions, as some reactions may exacerbate underlying health issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hyaluronic Acid.
Monitor for any unusual symptoms and report them to your healthcare provider. Follow the prescribed dosage and usage instructions carefully.
Hyaluronic Acid has 2,531 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and respiratory failure, are present but less common. The volume of reports for Hyaluronic Acid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hyaluronic acid products, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with HYALURONIC ACID:
Drugs related to HYALURONIC ACID based on therapeutic use, drug class, or shared indications: