VENTOLIN FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 2,530 U.S. reports for VENTOLIN (ALBUTEROL SULFATE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

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 VENTOLIN Report.

Top Adverse Events Reported with VENTOLIN (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	SHORTNESS OF BREATH	195
2	DEATH	169
3	NAUSEA	139
4	HEADACHE	110
5	DIZZINESS	109
6	FATIGUE	104
7	DRUG INEFFECTIVE	100
8	HOSPITALIZATION	98
9	THERAPY CESSATION	93
10	PNEUMONIA	83
11	PRODUCT SUBSTITUTION ISSUE	83
12	DIARRHEA	77
13	LACK OF STRENGTH AND ENERGY (ASTHENIA)	71
14	THERAPY INTERRUPTED	69
15	DISEASE PROGRESSION	66
16	VOMITING	66
17	PAIN	65
18	CONDITION AGGRAVATED	60
19	ASTHMA	59
20	CHEST PAIN	59
21	COUGH	56
22	ANXIETY	55
23	INSOMNIA	53
24	JOINT PAIN	50
25	TREMOR	49

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VENTOLIN Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
781	1677	72	2,530

Medwatch Reporter Type	Count
Consumer	826
Physician	94
Pharmacist	662
Other Health Professional	536

Top Indications

Product used for unknown indication
Asthma
Pulmonary function test
Chronic obstructive pulmonary disease

Type of Outcome Reported
Serious: 1851
Not Serious: 679
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: 2529
Concomitant Drugs: 2410
Note: A single MedWatch report can list more than one drug. This summary includes VENTOLIN identified as the suspect drug or as a concomitantly taken drug.

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.