Prescription and over-the-counter medicine
Budesonide Brand names: Pulmicort, Uceris, Eohilia, Tarpeyo; first approved as Rhinocort
Budesonide (Pulmicort) is a prescription and over-the-counter medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.498 per budesonide DR 3 mg capsule in the October 7, 2026 NADAC survey; its other strengths are brand-only, $3.29 per mL (Eohilia 2 mg/10 mL packet).
- Generic listed
Check it at the source: the budesonide FDA label on DailyMed (effective October 11, 2019, AstraZeneca Pharmaceuticals LP); the NDA 20233 record on Drugs@FDA; every budesonide label on DailyMed.
Highlights of the record
FDA label of October 11, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePULMICORT RESPULES ® 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 PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years o
Forms and strengths
- 2 mg
- 3 mg
- 4 mg
- 9 mg
- 0.25 mg/2ml
- 0.5 mg/2ml
- 1 mg/2ml
- 2 mg/10ml
Suspension; inhalant; aerosol (powder); capsule (coated pellets); spray (metered).
On the market
- Earliest approval on file
- February 14, 1994 Rhinocort, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first November 18, 2008; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 40 of which 30 under generic applications, 12 under brand applications, repackagers included
- Last listed patent
- January 23, 2043 Tarpeyo capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.498 per capsule Budesonide DR 3 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2012 0 Class I among all firms' recalls; latest May 29, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 58,575 through July 30, 2026
What is budesonide used for?
From the label: indications and usagePULMICORT RESPULES ® 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 PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use:
PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.
Conditions named in the indications of budesonide's FDA labels, with every medicine labeled for each:
From other budesonide labelsAllergies: Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
Crohn's disease and ulcerative colitis: Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (PULMICORT RESPULES), AstraZeneca Pharmaceuticals LP, effective October 11, 2019 (SPL set 33cd9834-76df-4f26-3fa2-aab6b9eee8f2), via openFDA; the full label on DailyMed
Is there a generic for budesonide (Pulmicort)?
The FDA approved the first generic budesonide on November 18, 2008. 21 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists budesonide from 30 labelers under a generic (ANDA) application and from 12 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Pulmicort Flexhaler powder; a patent listed only for Tarpeyo capsules runs to January 23, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1994 earliest approval on file
- 2008 first generic approved
- 2043 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for budesonide (Pulmicort)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.498 per Budesonide DR 3 mg capsule, down 3% from $0.515 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Budesonide 0.5 mg/2 mL suspension (generic)
- Eohilia 2 mg/10 mL packet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Budesonide 0.25 mg/2 mL suspension | Generic | $0.697 per mL | n/a | -13% |
| Budesonide 0.5 mg/2 mL suspension | Generic | $0.676 per mL | n/a | -10% |
| Budesonide 1 mg/2 mL inhaler suspension | Generic | $3.43 per mL | n/a | -17% |
| Budesonide 2 mg rectal foam | Generic | $9.56 per gram | n/a | +2% |
| Budesonide 32 mcg nasal spray | Generic | $1.41 per mL | n/a | -1% |
| Budesonide DR 3 mg capsule | Generic | $0.498 per capsule | $14.93 | -3% |
| Budesonide ec 3 mg capsule | Generic | $0.498 per capsule | $14.93 | -3% |
| Budesonide ER 9 mg tablet | Generic | $15.55 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $466.47 | +14% |
| Eohilia 2 mg/10 mL packet | Brand | $3.29 per mL | n/a | n/a |
| Pulmicort 0.5 mg/2 mL respule | Brand | $4.91 per mL | n/a | -0.2% |
| Pulmicort 1 mg/2 mL respule | Brand | $9.84 per mL | n/a | +0.1% |
| Pulmicort 180 mcg flexhaler | Brand | $253.50 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | no change |
| Pulmicort 90 mcg flexhaler | Brand | $188.52 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has budesonide been recalled?
The FDA's Enforcement Report lists 11 recalls naming budesonide since 2012: 0 Class I (the most serious), 8 Class II, 3 Class III; 3 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of budesonide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 29, 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 … |
| June 30, 2025 | Class II | Cipla USA, Inc. | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. |
| June 26, 2024 | Class II | Medisca Inc. | CGMP Deviations and Presence of Particulate Matter: Glass |
| January 12, 2024 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications |
| January 8, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Failed Dissolution Specifications |
| September 15, 2022 | Class II | CIPLA | Lack of Assurance of Sterility |
| November 12, 2019 | Class II | Integrated Health Concepts Inc. dba Conversio Health not a listed maker | Lack of Processing Controls |
| May 15, 2013 | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the budesonide label say about other medicines?
The budesonide label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name budesonide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) … |
| Clarithromycin | drug interactions | Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) … |
| Cyclosporine | drug interactions | Concomitant use of budesonide with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice) can increase systemic budesonide concentrations [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | Concomitant use of budesonide with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice) can increase systemic budesonide concentrations [see Clinical Pharmacology (12.3) ]. |
| Itraconazole | drug interactions | Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) … |
| Ketoconazole | drug interactions | After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. |
| Nefazodone | drug interactions | Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) … |
| Nelfinavir | drug interactions | Caution should be exercised when considering the coadministration of PULMICORT RESPULES with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) … |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | drug interactions | DRUG INTERACTIONS Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. |
Other labels that name budesonide
Source: FDA drug label (PULMICORT RESPULES), 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 for budesonide?
The FDA Adverse Event Reporting System holds 58,575 reports that list budesonide among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as budesonide?
14 other medicines are given the same way (oral) and in the same FDA class as budesonide or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Prednisone | Asthma, Crohn's disease and ulcerative colitis | 46 labelers | $0.0643 per tablet 20 mg tablet | No current entry |
| Dexamethasone | Asthma, Crohn's disease and ulcerative colitis | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Hydrocortisone | Asthma, Crohn's disease and ulcerative colitis | 16 labelers | $0.180 per tablet 10 mg tablet | A presentation being discontinued |
| Methylprednisolone | Crohn's disease and ulcerative colitis | 24 labelers | $0.121 per tablet 4 mg tablet | In shortage |
| Prednisolone | Asthma, Crohn's disease and ulcerative colitis | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Cortisone | Asthma, Crohn's disease and ulcerative colitis | 1 labeler | n/a | No current entry |
| Montelukast | Asthma | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as budesonide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does budesonide compare with medicines for the same use?
11 side-by-side pages set budesonide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to budesonide
- 14 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Budesonide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other