82/100 · Critical
Manufactured by Amneal Pharmaceuticals NY LLC
Albuterol Adverse Events Show High Seriousness and Diverse Reactions
283,047 FDA adverse event reports analyzed
Last updated: 2026-05-12
ALBUTEROL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 283,047 FDA adverse event reports, ALBUTEROL has a safety score of 82 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 include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALBUTEROL.
Albuterol has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 283,047 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Dyspnoea, Asthma, Drug Ineffective. Of classified reports, 68.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Albuterol reports show a high percentage of serious adverse events (68.2%).
The most common reactions include dyspnea, asthma, and drug ineffectiveness. A wide range of reactions are reported, indicating diverse safety concerns.
Patients taking Albuterol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Albuterol may interact with other medications, and patients should be aware of potential side effects and consult healthcare providers for proper use. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Albuterol received a safety concern score of 82/100 (high concern). This is based on a 68.2% serious event ratio across 113,932 classified reports. The score accounts for 283,047 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: 66,902, Male: 37,745, Unknown: 131. The most frequently reported age groups are age 65 (1,888 reports), age 60 (1,794 reports), age 61 (1,764 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 113,932 classified reports for ALBUTEROL:
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.
Albuterol may interact with other medications, and patients should be aware of potential side effects and consult healthcare providers for proper use.
If you are taking Albuterol, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, drug ineffective, cough, pneumonia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosage and usage instructions. Report any serious adverse events to healthcare providers immediately. 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 ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug.
The FDA has received approximately 283,047 adverse event reports associated with Albuterol. 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 include Dyspnoea, Asthma, Drug Ineffective, Cough, Pneumonia. By volume, the top reported reactions are: Dyspnoea (15,968 reports), Asthma (9,279 reports), Drug Ineffective (8,813 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.
Out of 113,932 classified reports, 77,744 (68.2%) were classified as serious and 36,188 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 break down by patient sex as follows: Female: 66,902, Male: 37,745, Unknown: 131. 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 adverse events are: age 65: 1,888 reports, age 60: 1,794 reports, age 61: 1,764 reports, age 62: 1,718 reports, age 72: 1,695 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 adverse event reports is Amneal Pharmaceuticals Ny 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 Albuterol include: Nausea, Fatigue, Headache, Pain, Off Label Use. 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 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 has a safety concern score of 82 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. Albuterol reports show a high percentage of serious adverse events (68.2%).
Key safety signals identified in Albuterol's adverse event data include: High percentage of serious adverse events (68.2%).. Common reactions include dyspnea, asthma, and drug ineffectiveness.. Diverse reactions reported, including respiratory, gastrointestinal, and neurological issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Albuterol may interact with other medications, and patients should be aware of potential side effects and consult healthcare providers for proper use. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Albuterol.
Always follow prescribed dosage and usage instructions. Report any serious adverse events to healthcare providers immediately.
Albuterol has 283,047 adverse event reports on file with the FDA. The most common reactions include dyspnea, asthma, and drug ineffectiveness. The volume of reports for Albuterol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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