budesonide Side Effects
Also known as: Pulmicort, Entocort
Analysis of 55,389 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
55,389
Death-Related
3,535
6.4% of reports
Hospitalizations
17,576
31.7% 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 3,535 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,218 |
| OFF LABEL USE | 382 |
| PNEUMONIA | 374 |
| DYSPNOEA | 304 |
| RENAL FAILURE | 231 |
| DRUG INEFFECTIVE | 227 |
| RESPIRATORY FAILURE | 227 |
| PULMONARY EMBOLISM | 217 |
| CONDITION AGGRAVATED | 215 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 210 |
| SEPSIS | 206 |
| ACUTE KIDNEY INJURY | 188 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 187 |
| DIARRHOEA | 187 |
| LUNG DISORDER | 179 |
| PRODUCT USE IN UNAPPROVED INDICATION | 155 |
| PYREXIA | 154 |
| ASTHMA | 152 |
| ASTHENIA | 150 |
| ANAEMIA | 146 |
Reactions in Hospitalization Reports
Top reactions in 17,576 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 2,848 |
| ASTHMA | 2,176 |
| PNEUMONIA | 1,839 |
| DRUG INEFFECTIVE | 1,749 |
| OFF LABEL USE | 1,722 |
| WHEEZING | 1,381 |
| PYREXIA | 1,248 |
| CONDITION AGGRAVATED | 1,233 |
| HEADACHE | 1,185 |
| NAUSEA | 1,180 |
| COUGH | 1,159 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 1,119 |
| FATIGUE | 1,111 |
| PAIN | 1,111 |
| DIARRHOEA | 1,059 |
| ABDOMINAL PAIN | 964 |
| MALAISE | 958 |
| WEIGHT DECREASED | 912 |
| VOMITING | 904 |
| LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES | 834 |
Nearby — Related Medications
What the FAERS Data Reveals About budesonide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 55,389 voluntary reports linked to budesonide and its brand equivalents (Pulmicort, Entocort), spanning 2002 through 2025. Of those, 3,535 (6.4%) listed death as an outcome and 17,576 (31.7%) 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, 59% were female and 41% male; age distribution skews toward 45-64, with 11,789 reports in that bracket. The single most reported reaction is dyspnoea with 6,364 submissions, followed by drug ineffective and off label use.
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.
Read our methodology — how this data is sourced, computed, and verified.