· Brand: Proair Hfa, Proventil-Hfa + 3 more

Albuterol Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on June 23, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Asthma & breathing

Quick answer

Based on 291,000+ FDA adverse event reports, the most-reported albuterol reactions include dyspnoea, asthma, and cough. FDA reports 3 active Class II recalls of albuterol, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Albuterol

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for albuterol. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Dyspnoea	42,188	14.5%
Asthma	24,489	8.4%
Cough	19,881	6.8%
Wrong Technique In Product Usage Process	18,712	6.4%
Fatigue	16,464	5.6%
Pneumonia	16,372	5.6%
Headache	15,246	5.2%
Nausea	14,338	4.9%
Wheezing	13,604	4.7%
Pain	12,758	4.4%

Source: FDA FAERS·Updated June 23, 2026·n=291,466+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports
Serious reports (any flag)	165,443
Hospitalization	83,316

From the FDA-approved label, Section 5.1: Paradoxical Bronchospasm Albuterol Sulfate

HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

From the FDA-approved label, Section 5.4: Cardiovascular Effects Albuterol Sulfate

HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, Albuterol Sulfate HFA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, Albuterol Sulfate HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Source: DailyMed (albuterol label)·Updated June 23, 2026

Albuterol Recalls

FDA enforcement actions matched to albuterol via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2025-08-27	Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. Cipla USA, Inc.	Class III	20352 packs (1x 200 MD)	Ongoing
2017-05-31	Defective Delivery System: Elevated number of units with out of specification results for leak rate GlaxoSmithKline, LLC	Class II	562,883	Ongoing
2017-04-12	Defective Delivery System: Elevated number of units with out of specification results for leak rate. GlaxoSmithKline, LLC	Class II	593,088 inhalers	Ongoing

Source: FDA Drug Enforcement Reports·Updated June 23, 2026·Refreshes every 6 hours·verify on FDA →

Show 12 closed recalls (2012 to 2024)

Includes resolved and terminated recalls matched to albuterol. Most recent first.

Date	Reason	Class	Quantity	Status
2024-01-03	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE	Class II	2 cartons	Terminated
2024-01-03	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE	Class II	11 cartons	Terminated
2023-07-19	Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). Cipla USA, Inc.	Class I	278,538 canisters	Terminated
2022-06-15	cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office	Class II	96 pouches	Terminated
2022-06-15	cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office	Class II	1 aerosol	Terminated
2022-06-15	cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office	Class II	23 pouches	Terminated
2022-06-15	cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office	Class II	1 carton/30 pouches each	Terminated
2020-09-30	Defective Delivery System: Sustained trend of failure to dispense complaints. Perrigo Company PLC	Class II	7,775,813 metered dose inhalers	Terminated
2015-12-16	Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. GlaxoSmithKline, LLC	Class II	128,704 Inhalers	Terminated
2013-10-30	Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. Nephron Pharmaceuticals Corp.	Class II	689,568 cartons	Terminated
2012-09-05	Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. GlaxoSmithKline Inc	Class II	1,412,566 inhalers	Terminated
2012-08-15	Lack of Assurance of Sterility Nephron Pharmaceuticals Corp.	Class II	56,028 cartons	Terminated

Albuterol Shortages

FDA-listed shortages of albuterol products. Strength and dosage-form level detail.

No active or recent shortages of albuterol are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated June 23, 2026

Is Albuterol Safe?

Albuterol is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers paradoxical bronchospasm albuterol sulfate (Section 5.1), deterioration of asthma (Section 5.2), use of anti-inflammatory (Section 5.3), cardiovascular effects albuterol sulfate (Section 5.4), do not exceed recommended dose (Section 5.5), hypersensitivity reactions, including anaphylaxis (Section 5.6), coexisting conditions albuterol sulfate (Section 5.7), hypokalemia (Section 5.8).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (albuterol label)·Updated June 23, 2026

FDA-Approved Indications

Albuterol is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Asthma & breathing

Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older.

Source: DailyMed (albuterol label)·Updated June 23, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of albuterol?

Dyspnoea, asthma, and cough are among the most-reported reactions in FDA FAERS data for albuterol. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is albuterol the same as Proair Hfa?

Albuterol is the generic name; Proair Hfa is a brand name for the same active ingredient. Other brand names include Proventil-Hfa, Proair Digihaler, Proair Respiclick, and Ventolin Hfa. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has albuterol been recalled?

Yes. Albuterol has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, subpotent or out-of-spec content, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are albuterol's current ongoing recalls about?

Active albuterol recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is subpotent or out-of-spec content. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.