VENTOLIN FDA MedWatch Direct Reports Summary
These tables and charts are created from 2,507 voluntary U.S. reports for VENTOLIN (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 VENTOLIN Report.
Top Adverse Effects Associated with VENTOLIN (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 SHORTNESS OF BREATH 192 2 DEATH 168 3 NAUSEA 137 4 DIZZINESS 109 5 HEADACHE 108 6 FATIGUE 104 7 DRUG INEFFECTIVE 99 8 HOSPITALIZATION 97 9 THERAPY CESSATION 92 10 PRODUCT SUBSTITUTION ISSUE 83 11 PNEUMONIA 82 12 DIARRHEA 75 13 LACK OF STRENGTH AND ENERGY (ASTHENIA) 71 14 THERAPY INTERRUPTED 68 15 DISEASE PROGRESSION 66 16 PAIN 64 17 VOMITING 64 18 CONDITION AGGRAVATED 60 19 CHEST PAIN 59 20 ASTHMA 57 21 COUGH 56 22 ANXIETY 55 23 INSOMNIA 53 24 JOINT PAIN 50 25 TREMOR 49
VENTOLIN Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 775 | 1662 | 70 | 2,507 |
| Medwatch Reporter Type | Count |
| Consumer | 815 |
| Physician | 94 |
| Pharmacist | 657 |
| Other Health Professional | 533 |
| Top Indications | |
| Product used for unknown indication | |
| Asthma | |
| Pulmonary function test | |
| Chronic obstructive pulmonary disease | |
Type of Outcome Reported
Serious: 1835
Not Serious: 672
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: 2506
Concomitant Drugs: 2390
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.