78/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Albuterol Sulfate Adverse Events: High Seriousness and Diverse Reactions
683,072 FDA adverse event reports analyzed
Last updated: 2026-05-12
ALBUTEROL SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 683,072 FDA adverse event reports, ALBUTEROL SULFATE has a safety score of 78 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 ALBUTEROL SULFATE include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALBUTEROL SULFATE.
Albuterol Sulfate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 683,072 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Dyspnoea, Asthma, Drug Ineffective. Of classified reports, 57.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving respiratory issues.
A wide variety of reactions are reported, indicating a complex safety profile. Drug ineffectiveness and device-related issues are common, suggesting potential misuse or product quality concerns.
Patients taking Albuterol Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include potential misuse of the device and product quality issues, which can lead to ineffectiveness or adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Albuterol Sulfate received a safety concern score of 78/100 (high concern). This is based on a 57.2% serious event ratio across 279,780 classified reports. The score accounts for 683,072 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: 160,535, Male: 86,859, Unknown: 258. The most frequently reported age groups are age 65 (4,035 reports), age 62 (3,878 reports), age 60 (3,744 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 279,780 classified reports for ALBUTEROL SULFATE:
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.
Warnings include potential misuse of the device and product quality issues, which can lead to ineffectiveness or adverse reactions.
If you are taking Albuterol Sulfate, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, drug ineffective, cough, wrong technique in product usage process. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure proper device usage and follow the prescribed dosage instructions. Report any adverse events to the FDA's MedWatch program for further evaluation. 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 albuterol sulfate for safety, with ongoing reviews to address serious and common adverse events.
The FDA has received approximately 683,072 adverse event reports associated with Albuterol Sulfate. 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 Albuterol Sulfate include Dyspnoea, Asthma, Drug Ineffective, Cough, Wrong Technique In Product Usage Process. By volume, the top reported reactions are: Dyspnoea (40,762 reports), Asthma (23,813 reports), Drug Ineffective (21,851 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Albuterol Sulfate.
Out of 279,780 classified reports, 159,905 (57.2%) were classified as serious and 119,875 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 Albuterol Sulfate break down by patient sex as follows: Female: 160,535, Male: 86,859, Unknown: 258. 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 Albuterol Sulfate adverse events are: age 65: 4,035 reports, age 62: 3,878 reports, age 60: 3,744 reports, age 61: 3,707 reports, age 66: 3,694 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 Albuterol Sulfate adverse event reports is Aurobindo Pharma Limited. 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 Albuterol Sulfate include: Fatigue, Pneumonia, Headache, Nausea, Wheezing. 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 Albuterol Sulfate 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.
Albuterol Sulfate has a safety concern score of 78 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 adverse events are serious, with a high percentage of reports involving respiratory issues.
Key safety signals identified in Albuterol Sulfate's adverse event data include: High percentage of serious adverse events (57.2%). Respiratory issues like dyspnea and asthma are frequently reported. Device-related issues and drug ineffectiveness are significant safety signals. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warnings include potential misuse of the device and product quality issues, which can lead to ineffectiveness or adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Albuterol Sulfate.
Ensure proper device usage and follow the prescribed dosage instructions. Report any adverse events to the FDA's MedWatch program for further evaluation.
Albuterol Sulfate has 683,072 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating a complex safety profile. The volume of reports for Albuterol Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor albuterol sulfate for safety, with ongoing reviews to address serious and common adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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