Budesonide: uses, dosing, side effects & brands
Budesonide is a corticosteroid sold in the U.S. under 9 brand and generic names, for perennial allergic rhinitis and inflammatory bowel diseases. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Corticosteroid
- Treats (across its forms)
- Perennial Allergic Rhinitis and Inflammatory Bowel Diseases
- Available as
- Powder, metered · Suspension · Spray/Inhaler, metered · Capsule, delayed release · Spray/Inhaler · Tablet, extended release · Topical
- Sold as
- 9 products — Pulmicort, Pulmicort Respules and Rhinocort, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Not in our catalog
- Half-life
- about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing)
- What the pharmacy pays
- about $0.75 per ml — not your price
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How Pulmicort Respules is dosed
From the FDA label for Pulmicort Respules (application NDA020929). Other budesonide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended starting dose and highest recommended dose of PULMICORT RESPULES, based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators alone 0.5 mg total daily dose administered either once daily or twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered either once daily or twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily 1 mg total daily dose Recommended dosing based on previous therapy ( 2 ). Start with the lowest recommended dose: • Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily • Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily • In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered • If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. Once asthma stability is achieved, titrate the dose downwards • For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. ( 2.2 ) 2.1 Dosing…
Everything below is the FDA label for Pulmicort Respules (suspension). Budesonide is also sold as powder, metered, spray/inhaler, metered, capsule, delayed release, spray/inhaler, tablet, extended release and topical, and those are different medicines to take — follow the label for the one you were prescribed.
Pulmicort Respules side effects
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) , 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…
Who shouldn’t take Pulmicort Respules
The use of PULMICORT RESPULES 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 PULMICORT RESPULES [see Warnings and Precautions (5.3) , Description (11) , 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 PULMICORT RESPULES ( 4 )
Pulmicort Respules drug interactions
Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects ( 5.12 , 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. 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) , Clinical Pharmacology (12.3) ] .
Every budesonide product we track (9)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Powder | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Suspension | Generic | $1 | View → | |
| 3 | 70/100 | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 4 | 70/100 | Over-the-counter | Spray/Inhaler | Generic | $1 | View → | |
| 5 | Not yet rated | Prescription | Suspension | Generic | $1 | View → | |
| 6 | Not yet rated | Prescription | Capsule | Generic | $1 | View → | |
| 7 | Not yet rated | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 8 | Not yet rated | Prescription | Capsule | Generic | $1 | View → | |
| 9 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
What budesonide pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 720 | 3 mg | orange, white | capsule | — |
Combination products containing budesonide
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Budesonide recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Budesonide Inhalation Suspension
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
SUN PHARMACEUTICAL INDUSTRIES INC · May 29, 2026
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA, Inc. · Jun 30, 2025
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p…
CGMP Deviations and Presence of Particulate Matter: Glass
Medisca Inc. · Jun 26, 2024
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Golden State Medical Supply Inc. · Jan 12, 2024
Budesonide Extended-Release Tablets 9mg
Failed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 8, 2024
Can you crush or split budesonide?
At least one budesonideproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each budesonide label says about crushing, splitting and chewingHow long budesonide keeps
No budesonide label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does budesonide expire? The in-use limits and storage rules from its labelsBudesonide and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for budesonide: levels in milk, effects in breastfed infants, and the drugs it would consider insteadThe amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk. Expert opinion considers inhaled, nasal, oral and rectal corticosteroids acceptable to use during breastfeeding.
National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about budesonide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 61,489 reports naming budesonide, and the FDA flagged 80% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea9,154 reports
- asthma7,816 reports
- wheezing4,746 reports
- cough4,398 reports
- therapeutic product effect incomplete3,755 reports
- fatigue3,665 reports
- pneumonia3,572 reports
- headache3,339 reports
Read these as a signal, not a rate. A report does not mean budesonide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long budesonide stays in your system
The elimination half-life of budesonide is about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing). The label reports the true (terminal) plasma elimination half-life from IV dosing as 2 to 3.6 hours, the same in healthy adults and Crohn's disease patients. The APPARENT half-life after ORAL dosing is longer — mean 6.3 ± 1.6 hours (range 2 to 8 hours) after a single 9 mg dose in healthy fasted subjects — because absorption is slower than elimination (flip-flop kinetics), not because the drug lingers; use the ~2–3.6 h IV figure as the elimination half-life. Budesonide is NOT a prodrug and has NO longer-lasting active metabolite: its two major CYP3A4 metabolites (6β-hydroxy budesonide and 16α-hydroxy prednisolone) have negligible corticosteroid activity (<1/100 of the parent). Liver impairment: budesonide is a high-hepatic-clearance drug, so systemic exposure rises with impaired liver function — patients with moderate impairment (Child-Pugh B) had a 3.5-fold higher AUC than those with normal liver function, and the label says to avoid use in severe impairment (Child-Pugh C). Kidney impairment: the label gives no PK half-life change (budesonide is cleared hepatically, not renally). Older adults: the label states studies did not include enough patients aged 65+ to characterize any difference. This is an elimination half-life, not a drug-test detection window and not dosing guidance.
Budesonide (oral) FDA label, §12.3 Pharmacokinetics — DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Pulmicort Respules?
Pulmicort Respules (Budesonide) is a corticosteroid used to treat Perennial Allergic Rhinitis, Inflammatory Bowel Diseases.
What kind of drug is budesonide?
The FDA classifies budesonide as a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does budesonide stay in your system?
The elimination half-life of budesonide is about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) — that is how long the body takes to clear half of a dose. The label reports the true (terminal) plasma elimination half-life from IV dosing as 2 to 3.6 hours, the same in healthy adults and Crohn's disease patients. The APPARENT half-life after ORAL dosing is longer — mean 6.3 ± 1.6 hours (range 2 to 8 hours) after a single 9 mg dose in healthy fasted subjects — because absorption is slower than elimination (flip-flop kinetics), not because the drug lingers; use the ~2–3.6 h IV figure as the elimination half-life. Budesonide is NOT a prodrug and has NO longer-lasting active metabolite: its two major CYP3A4 metabolites (6β-hydroxy budesonide and 16α-hydroxy prednisolone) have negligible corticosteroid activity (<1/100 of the parent). Liver impairment: budesonide is a high-hepatic-clearance drug, so systemic exposure rises with impaired liver function — patients with moderate impairment (Child-Pugh B) had a 3.5-fold higher AUC than those with normal liver function, and the label says to avoid use in severe impairment (Child-Pugh C). Kidney impairment: the label gives no PK half-life change (budesonide is cleared hepatically, not renally). Older adults: the label states studies did not include enough patients aged 65+ to characterize any difference. This is an elimination half-life, not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take budesonide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run budesonide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is budesonide sold under?
We track 9 budesonide-containing products in the U.S.: Pulmicort, Pulmicort Respules, Rhinocort, Rhinocort Allergy, Eohilia, Ortikos, Pulmicort Flexhaler and Tarpeyo, and 1 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does budesonide come in?
Across the brands we track, budesonide is currently marketed as powder, metered, suspension, spray/inhaler, metered, capsule, delayed release, spray/inhaler, tablet, extended release and topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic budesonide?
We do not currently list a generic-labelled budesonide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has budesonide been recalled?
The FDA's Enforcement database lists at least 5 recall records whose product description mentions budesonide. The most recent: Budesonide Inhalation Suspension (May 29, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Budesonide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/budesonide
- MLA
- “Budesonide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/budesonide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for budesonide on DailyMed (NIH) ↗.