85/100 · Critical
Manufactured by Chain Drug Marketing Association Inc.
Serious Adverse Reactions Common in Anti-itch Cream Reports
229,212 FDA adverse event reports analyzed
Last updated: 2026-05-12
ANTI ITCH CREAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chain Drug Marketing Association Inc.. Based on analysis of 229,212 FDA adverse event reports, ANTI ITCH CREAM 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 CREAM 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 CREAM.
Anti-Itch Cream 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 229,212 adverse event reports for this medication, which is primarily manufactured by Chain Drug Marketing Association 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 and death, are reported frequently.
A wide range of reactions, including systemic lupus erythematosus and pericarditis, indicate diverse potential side effects. Report volume is substantial, with over 229,000 reports, suggesting widespread use and potential issues.
Patients taking Anti-Itch Cream 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 patients should avoid off-label use and ensure proper application as directed. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Anti-Itch Cream received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,586 classified reports. The score accounts for 229,212 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: 32,036, Male: 23,628, Unknown: 130. The most frequently reported age groups are age 43 (1,430 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 63,586 classified reports for ANTI ITCH CREAM:
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 patients should avoid off-label use and ensure proper application as directed.
If you are taking Anti-Itch Cream, 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. Follow the product instructions carefully to avoid misuse and potential serious side effects. Report any unusual symptoms to a healthcare provider promptly. 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 closely monitors these reports and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 229,212 adverse event reports associated with Anti-Itch Cream. 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 Cream 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 (5,579 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 Cream.
Out of 63,586 classified reports, 53,042 (83.4%) were classified as serious and 10,544 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 Cream break down by patient sex as follows: Female: 32,036, Male: 23,628, 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 Cream adverse events are: age 43: 1,430 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 Cream adverse event reports is Chain Drug Marketing Association 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 Cream 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 Cream 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 Cream 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 and death, are reported frequently.
Key safety signals identified in Anti-Itch Cream's adverse event data include: Pneumonia and death are among the most serious reactions reported.. Systemic lupus erythematosus and pericarditis are key safety signals indicating potential autoimmune reactions.. A diverse range of reactions, including gastrointestinal and musculoskeletal issues, suggest a broad 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 patients should avoid off-label use and ensure proper application as directed. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Anti-Itch Cream.
Follow the product instructions carefully to avoid misuse and potential serious side effects. Report any unusual symptoms to a healthcare provider promptly.
Anti-Itch Cream has 229,212 adverse event reports on file with the FDA. A wide range of reactions, including systemic lupus erythematosus and pericarditis, indicate diverse potential side effects. The volume of reports for Anti-Itch Cream reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these reports and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Chain Drug Marketing Association Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with ANTI ITCH CREAM:
Drugs related to ANTI ITCH CREAM based on therapeutic use, drug class, or shared indications: