What the label lists and what reports show
Budesonide side effects
Budesonide's FDA label: “Most common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash” FAERS holds 58,575 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (6,568 reports).
- Generic listed
Check it at the source: the budesonide FDA label on DailyMed (effective October 11, 2019, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PULMICORT RESPULES?PULMICORT RESPULES may cause serious side effects including: • Thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if your child has any redness or white colored patches in the mouth or throat. • Worsening of asthma or sudden asthma attacks. • Allergic reactions. Tell your healthcare provider or get medical help right away if your child has: o skin rash, redness or swelling o severe itching o swelling of the face, mouth and tongue o trouble breathing or swallowing o chest pain o anxiety (feeling of doom) • Immune system effects and a higher chance of infections. Your child is more likely to get infections when taking medicines that weaken the immune system. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective October 11, 2019 (SPL set 33cd9834-76df-4f26-3fa2-aab6b9eee8f2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash
Table 1: Common Adverse Reactions reported in at least 2% of subjects in the EOHILIA group and at a rate greater than placebo. in Adult and Pediatric Subjects 11 Years of Age and Older with EoE in Study 1
This table is printed in the Eohilia label published by TAKEDA PHARMACEUTICALS AMERICA, INC. of February 3, 2025; the label quoted above does not print one.
| ADVERSE REACTIONS | EOHILIA 2 mg Twice Daily N = 213 | Placebo N = 105 |
|---|---|---|
| Respiratory tract infection includes acute sinusitis, sinusitis, nasopharyngitis,… | 13% | 11% |
| Gastrointestinal mucosal candidiasis includes esophageal candidiasis, oropharyngeal… | 8% | 2% |
| Headache includes headache, migraine | 5% | 2% |
| Gastroenteritis | 3% | 1% |
| Throat irritation includes throat irritation, oropharyngeal pain | 3% | 2% |
| Adrenal suppression includes adrenal suppression, adrenal insufficiency | 2% | 0 |
| Erosive esophagitis includes esophagitis only where erosions were present at the… | 2% | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedSystemic and inhaled corticosteroid use may result in the following: • Candida albicans Infection [see Warnings and Precautions (5.1) ] • Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ] • Immunosuppression [see Warnings and Precautions (5.4) ] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] • Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] • Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8), Use in Specific Populations (8.4) ] • Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] • Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1–800–236–9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective October 11, 2019 (SPL set 33cd9834-76df-4f26-3fa2-aab6b9eee8f2), via openFDA; the full label on DailyMed
What do FAERS reports show?
58,575 reports list budesonide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,687 are coded as a death and 18,359 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Budesonide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions