85/100 · Critical
Manufactured by HyVee Inc
Serious Adverse Reactions Common in Anti-Itch Drug Reports
229,210 FDA adverse event reports analyzed
Last updated: 2026-05-12
ANTI ITCH is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by HyVee Inc. Based on analysis of 229,210 FDA adverse event reports, ANTI ITCH has a safety score of 85 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 ANTI ITCH include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, CONDITION AGGRAVATED, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ANTI ITCH.
Anti Itch has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 229,210 adverse event reports for this medication, which is primarily manufactured by Hyvee Inc.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 83.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse reactions such as pneumonia, dyspnoea, and death are reported frequently.
A high number of reports indicate drug ineffectiveness and off-label use. Fatigue and rash are among the most common non-serious adverse reactions.
Patients taking Anti Itch should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs, particularly those affecting the respiratory and cardiovascular systems, should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Anti Itch received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,589 classified reports. The score accounts for 229,210 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 32,040, Male: 23,627, Unknown: 130. The most frequently reported age groups are age 43 (1,429 reports), age 44 (1,197 reports), age 40 (1,043 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,589 classified reports for ANTI ITCH:
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.
Interactions with other drugs, particularly those affecting the respiratory and cardiovascular systems, should be monitored.
If you are taking Anti Itch, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, condition aggravated, nausea. 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 serious adverse reactions such as respiratory distress, chest pain, and fever. Follow prescribed usage guidelines strictly to avoid off-label use and drug ineffectiveness. 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.
Regulatory oversight is necessary given the high incidence of serious adverse events, and patients should report any unusual symptoms promptly.
The FDA has received approximately 229,210 adverse event reports associated with Anti Itch. 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 Anti Itch include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,923 reports), Drug Ineffective (7,049 reports), Fatigue (5,580 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Anti Itch.
Out of 63,589 classified reports, 53,042 (83.4%) were classified as serious and 10,547 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 Anti Itch break down by patient sex as follows: Female: 32,040, Male: 23,627, Unknown: 130. 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 Anti Itch adverse events are: age 43: 1,429 reports, age 44: 1,197 reports, age 40: 1,043 reports, age 60: 838 reports, age 65: 838 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 Anti Itch adverse event reports is Hyvee Inc. 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 Anti Itch include: Rash, Pain, Headache, Diarrhoea, 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 Anti Itch 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.
Anti Itch has a safety concern score of 85 out of 100 (high 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. Serious adverse reactions such as pneumonia, dyspnoea, and death are reported frequently.
Key safety signals identified in Anti Itch's adverse event data include: High percentage of serious reactions (83.4%). Multiple reports of drug ineffectiveness and off-label use. A wide range of reactions including systemic lupus erythematosus and pericarditis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs, particularly those affecting the respiratory and cardiovascular systems, should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Anti Itch.
Monitor for signs of serious adverse reactions such as respiratory distress, chest pain, and fever. Follow prescribed usage guidelines strictly to avoid off-label use and drug ineffectiveness.
Anti Itch has 229,210 adverse event reports on file with the FDA. A high number of reports indicate drug ineffectiveness and off-label use. The volume of reports for Anti Itch reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary given the high incidence of serious adverse events, and patients should report any unusual symptoms promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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