HIGH-VOLUME · HOSP-HEAVY
budesonide Side Effects
budesonide (also sold as Pulmicort, Entocort) is HIGH-VOLUME in this FAERS book #133 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 31.7% mention hospitalization (17,576 reports).
Data updated 2026-05-15
- 55,389
- FAERS reports
FAERS voluntary reports, 2002 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
budesonide: 31.7% mention hospitalization (17,576 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #133 of 524 by FAERS report count.
High-report extract for budesonide (Pulmicort): 55,389 FAERS rows (2002-2025). Top named reactions: DYSPNOEA, ASTHMA, FATIGUE. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2002–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DYSPNOEA leads 6,364 of 55,389 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (11,789 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (3,535 reports, 6.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 1,218 |
| PNEUMONIA | 374 |
| DYSPNOEA | 304 |
| RENAL FAILURE | 231 |
| 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 |
| PYREXIA | 154 |
| ASTHMA | 152 |
| ASTHENIA | 150 |
| ANAEMIA | 146 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (17,576, 31.7% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 2,848 |
| ASTHMA | 2,176 |
| PNEUMONIA | 1,839 |
| 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 |
How to read budesonide FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 55,389 voluntary reports linked to budesonide (Pulmicort, Entocort), 2002-2025. Death is listed on 3,535 (6.4%). Hospitalization appears on 17,576 (31.7%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with budesonide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 55,325 FAERS cases (Δ 64 lighter vs budesonide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,549 FAERS cases (Δ 160 heavier vs budesonide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,714 FAERS cases (Δ 325 heavier vs budesonide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 55,835 FAERS cases (Δ 446 heavier vs budesonide); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.7 pp vs budesonide's DEATH-HEAVY): CASELOAD · HOSP-MID.
budesonide stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.