Drug side effects
albuterol Side Effects
The reactions most often reported to the FDA for albuterol (also sold as Ventolin, ProAir), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 113,967
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 1995 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of albuterol come from 113,967 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 113,967 reports to the FDA Adverse Event Reporting System (FAERS) for albuterol (Ventolin): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
113,967
Reports Mentioning Death
9,607
8.4% of reports — not proof the medicine caused the death
Hospitalizations
41,765
36.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 9,607 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 3,210 |
| DYSPNOEA | 1,236 |
| PNEUMONIA | 1,136 |
| NAUSEA | 765 |
| VOMITING | 694 |
| ASTHMA | 672 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 668 |
| RESPIRATORY FAILURE | 663 |
| PYREXIA | 633 |
| CONDITION AGGRAVATED | 626 |
| FATIGUE | 620 |
| SEPSIS | 594 |
| ASTHENIA | 572 |
| PAIN | 539 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 536 |
| DIARRHOEA | 535 |
| ABDOMINAL PAIN | 507 |
| RENAL FAILURE | 491 |
| HEADACHE | 483 |
Reactions in Hospitalization Reports
Top reactions in 41,765 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 7,406 |
| PNEUMONIA | 5,318 |
| ASTHMA | 4,282 |
| NAUSEA | 3,045 |
| COUGH | 2,939 |
| PAIN | 2,834 |
| WHEEZING | 2,729 |
| FATIGUE | 2,581 |
| VOMITING | 2,489 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 2,423 |
| DIARRHOEA | 2,414 |
| FALL | 2,336 |
| PYREXIA | 2,242 |
| HEADACHE | 2,239 |
| ANXIETY | 2,165 |
| ASTHENIA | 2,125 |
| CONDITION AGGRAVATED | 1,954 |
| CHEST PAIN | 1,948 |
Nearby, Related Medications
What the FAERS Data Reveals About albuterol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 113,967 voluntary reports linked to albuterol and its brand equivalents (Ventolin, ProAir, Proventil), spanning 1995 through 2025. Of those, 9,607 (8.4%) listed death as an outcome and 41,765 (36.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 64% were female and 36% male; age distribution skews toward 45-64, with 26,153 reports in that bracket. The single most reported reaction is dyspnoea with 15,965 submissions, followed by asthma and cough.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to albuterol's 113,967.
Read our methodology - how this data is sourced, computed, and verified.