PROAIR HFA FDA MedWatch Direct Reports Summary

These tables and charts are created from 2,655 voluntary U.S. reports for PROAIR HFA (ALBUTEROL SULFATE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS PROAIR HFA Report.

Top Adverse Effects Associated with PROAIR HFA (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	SHORTNESS OF BREATH	191
2	DEATH	169
3	HOSPITALIZATION	140
4	NAUSEA	129
5	DRUG INEFFECTIVE	127
6	DIZZINESS	116
7	HEADACHE	111
8	FATIGUE	106
9	PRODUCT SUBSTITUTION ISSUE	101
10	PNEUMONIA	100
11	THERAPY CESSATION	91
12	CONDITION AGGRAVATED	87
13	DIARRHEA	86
14	PAIN	79
15	ASTHMA	71
16	RASH	71
17	DISEASE PROGRESSION	68
18	VOMITING	65
19	COUGH	64
20	THERAPY INTERRUPTED	63
21	LACK OF STRENGTH AND ENERGY (ASTHENIA)	61
22	JOINT PAIN	59
23	CHEST PAIN	57
24	ITCHING	57
25	DEVICE MALFUNCTION	54

Search all MedWatch Reports by Keyword:

PROAIR HFA Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
849	1755	51	2,655

Medwatch Reporter Type	Count
Consumer	822
Physician	87
Pharmacist	678
Other Health Professional	574

Top Indications

Product used for unknown indication
Chronic obstructive pulmonary disease
Asthma

Type of Outcome Reported
Serious: 1914
Not Serious: 741
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 2655
Concomitant Drugs: 2449
Note: A single MedWatch report can list more than one drug. This summary includes PROAIR HFA identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

PROAIR HFA (ALBUTEROL SULFATE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with PROAIR HFA? Rate PROAIR HFA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.