85/100 · Critical
Manufactured by A2A Integrated Pharmaceuticals, LLC
High Serious Reaction Rate for Antipruritic Drugs
229,196 FDA adverse event reports analyzed
Last updated: 2026-05-12
ANTIPRURITIC (ANTI ITCH) is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by A2A Integrated Pharmaceuticals, LLC. Based on analysis of 229,196 FDA adverse event reports, ANTIPRURITIC (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 ANTIPRURITIC (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 ANTIPRURITIC (ANTI ITCH).
Antipruritic (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 229,196 adverse event reports for this medication, which is primarily manufactured by A2a Integrated Pharmaceuticals, Llc.
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. The majority of reactions are non-serious, but the serious reaction rate is high at 83.4%.
A wide range of reactions are reported, indicating potential for diverse side effects. Report volume is substantial, with over 229,000 reports, suggesting widespread use and potential for underreporting.
Patients taking Antipruritic (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 are not well-documented, and patients should be cautious when using antipruritics for unapproved indications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Antipruritic (Anti-Itch) received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,581 classified reports. The score accounts for 229,196 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: 32,032, 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 63,581 classified reports for ANTIPRURITIC (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 are not well-documented, and patients should be cautious when using antipruritics for unapproved indications.
If you are taking Antipruritic (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. Patients should report any adverse reactions to their healthcare provider immediately. Avoid using antipruritics for unapproved indications unless specifically directed by a healthcare professional. 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 serious reaction rate, and further studies are needed to understand the safety profile of these drugs.
The FDA has received approximately 229,196 adverse event reports associated with Antipruritic (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 Antipruritic (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 (7,048 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 Antipruritic (Anti-Itch).
Out of 63,581 classified reports, 53,039 (83.4%) were classified as serious and 10,542 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 Antipruritic (Anti-Itch) break down by patient sex as follows: Female: 32,032, 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 Antipruritic (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 Antipruritic (Anti-Itch) adverse event reports is A2a Integrated 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 Antipruritic (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 Antipruritic (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.
Antipruritic (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. The majority of reactions are non-serious, but the serious reaction rate is high at 83.4%.
Key safety signals identified in Antipruritic (Anti-Itch)'s adverse event data include: High percentage of serious reactions (83.4%). Diverse range of reactions including fatalities and severe conditions like pneumonia and systemic lupus erythematosus. Significant number of reports involving off-label use and drug ineffectiveness. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are not well-documented, and patients should be cautious when using antipruritics for unapproved indications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Antipruritic (Anti-Itch).
Patients should report any adverse reactions to their healthcare provider immediately. Avoid using antipruritics for unapproved indications unless specifically directed by a healthcare professional.
Antipruritic (Anti-Itch) has 229,196 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating potential for diverse side effects. The volume of reports for Antipruritic (Anti-Itch) reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary given the high serious reaction rate, and further studies are needed to understand the safety profile of these drugs. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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