ALBUTEROL SULFATE FDA MedWatch Direct Reports Summary

These tables and charts are created from 2,200 voluntary U.S. reports for ALBUTEROL SULFATE (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 ALBUTEROL SULFATE Report.

Top Adverse Effects Associated with ALBUTEROL SULFATE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	SHORTNESS OF BREATH	191
2	DEATH	178
3	DRUG INEFFECTIVE	115
4	COUGH	93
5	NAUSEA	85
6	HEADACHE	83
7	PNEUMONIA	82
8	THERAPY INTERRUPTED	80
9	HOSPITALIZATION	72
10	FATIGUE	71
11	DIARRHEA	70
12	ASTHMA	68
13	DISEASE PROGRESSION	68
14	DIZZINESS	67
15	PRODUCT SUBSTITUTION ISSUE	65
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	52
17	VOMITING	50
18	THERAPY CESSATION	48
19	JOINT PAIN	46
20	ITCHING	46
21	CHEST PAIN	45
22	CONDITION AGGRAVATED	45
23	HOSPICE CARE	44
24	PAIN	44
25	ACUTE RESPIRATORY FAILURE	42

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ALBUTEROL SULFATE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
759	1330	111	2,200

Medwatch Reporter Type	Count
Consumer	678
Physician	118
Pharmacist	516
Other Health Professional	514

Top Indications

Asthma
Product used for unknown indication
Chronic obstructive pulmonary disease
SHORTNESS OF BREATH
Bronchitis

Type of Outcome Reported
Serious: 1540
Not Serious: 660
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: 2200
Concomitant Drugs: 1932
Note: A single MedWatch report can list more than one drug. This summary includes ALBUTEROL SULFATE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

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

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

COMBIVENT RESPIMAT (ALBUTEROL SULFATE; IPRATROPIUM BROMIDE) Rx Drug:
FDA Safety-related Labeling Changes

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

Have experience (good or bad) with PROAIR DIGIHALER? Rate PROAIR DIGIHALER 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.