This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3) , Description (11) and Adverse Reactions (6.2) ]. Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Hypersensitivity to any of the ingredients in budesonide inhalation suspension ( 4 )
Localized Infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. ( 5.1 ) Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) Hypersensitivity Reactions: Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.4 ) Transferring Patients from Systemic Corticosteroid Therapy: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension ( 5.5 ) Hypercorticism and Adrenal Suppression: May occur with v...
Systemic 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) and 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 of ≥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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varyin...
Source: FDA SPL label for Budesonide Inhalation (American Health Packaging), effective 20250612. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 5,627 | 6,419 | 6,315 | 6,666 | 7,218 | 7,310 | 6,551 | 3,588 |
27,136 reports blaming this drug for every million Medicare prescriptions filled, which is 9.8× the typical drug on this site. (17,388 reports in 2024–2026, against 640,774 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 05/2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution |
| 06/2025 | Class II | Cipla USA, Inc. | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. |
| 09/2022 | Class II | CIPLA | Lack of Assurance of Sterility |
| 01/2013 | Class III | AstraZeneca LP | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. |
| 01/2013 | Class III | AstraZeneca LP | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $3,797,090 in payments to US physicians and hospitals tied to this drug across 23,720 transactions (Tarpeyo $1,986,661, Eohilia $1,810,429).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Budesonide Dr | 207,194 | $128 |
| Budesonide | 173,739 | $181 |
| Pulmicort Flexhaler | 121,500 | $320 |
| Budesonide EC | 106,512 | $213 |
| Budesonide ER | 27,485 | $1,336 |
| Tarpeyo | 2,385 | $16,039 |
| Eohilia | 776 | $2,002 |
| Pulmicort | 638 | $440 |
1 drug in the same class grades a letter or more higher than budesonide on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.