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Budesonide

Budesonide is a corticosteroid (anti-inflammatory steroid) used for asthma, Crohn’s disease, ulcerative colitis, eosinophilic esophagitis and IgA nephropathy, depending on the product.

Brand names Entocort ECTarpeyoUcerisRhinocortOrtikos +6 more
Drug class Corticosteroid
Rx/OTC Forms 7
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 33 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 3
Other forms & routes:
Nasal Oral inhalation
Budesonide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Budesonide is a corticosteroid (an anti-inflammatory steroid) for asthma, Crohn's disease, ulcerative colitis, eosinophilic esophagitis (allergic inflammation of the esophagus) and IgA nephropathy (a kidney disease), depending on the product, and it acts mostly where it lands because the liver clears much of a swallowed dose; on the market since about 1993, it is widely available generically. Most people find it gentler than prednisone, though inhaled forms can cause thrush (a mouth yeast infection) and swallowed forms sometimes bring headache or nausea. Its boxed warning says the nebulizer liquid is for inhalation only, never swallowed, and goes only in a jet nebulizer with an air compressor, not an ultrasonic one.

Clinical pearls

  • Inhaled budesonide is a controller, not a rescue medicine; call your doctor if breathing worsens or your rescue inhaler stops helping.
  • Rinse your mouth with water and spit after each inhaled or nebulized dose to help prevent thrush.
  • Swallow capsules and Uceris tablets whole and skip grapefruit juice with them; clarithromycin, itraconazole and ritonavir also raise levels.
  • Report any chickenpox or measles exposure, signs of infection, or vision changes, since long-term use can raise glaucoma and cataract risk.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Budesonide inhalation suspension is for inhalation only. Do not swallow it. Use it only with a jet nebulizer connected to an air compressor. Do not use an ultrasonic nebulizer.

Read the full warning on DailyMed →
How you get itPrescription and over the counter
Comes asInhalation solution (nebulizer), Inhaler, Capsule +4
Earliest FDA record1993
Companies listing it with the FDA39
FDA label last updatedJun 10, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Budesonide, written from its FDA label.

What Budesonide is used for

▾

Budesonide is a corticosteroid used for different conditions depending on the product.

  • Asthma maintenance: Pulmicort Flexhaler (ages 6 and older); nebulized budesonide suspensions and Pulmicort Respules (ages 12 months to 8 years).
  • Mild to moderate active Crohn’s disease of the ileum and/or ascending colon: budesonide delayed-release capsules (ages 8 and older).
  • Maintaining Crohn’s remission for up to 3 months: budesonide delayed-release capsules (adults).
  • Active mild to moderate ulcerative colitis: Uceris extended-release tablets.
  • Active mild to moderate distal ulcerative colitis: Uceris or budesonide rectal foam.
  • Eosinophilic esophagitis: Eohilia oral suspension (12 weeks, ages 11 and older).
  • IgA nephropathy: Tarpeyo (adults at risk of progression).

How Budesonide works

▾

Budesonide is a corticosteroid that binds to glucocorticoid receptors, with about 200 times the affinity of cortisol. This dials down inflammation. In asthma, it calms many inflammatory cells and chemical messengers in the airways.

When inhaled, it works mostly locally in the lungs. The liver breaks down most swallowed drug, which helps limit effects elsewhere in the body.

Budesonide dosage

▾

Follow your prescriber and the label for your specific product.

  • Inhaled forms: by inhalation only; rinse your mouth after use. Nebulized suspension needs a jet nebulizer with an air compressor.
  • Crohn’s capsules and Uceris tablets: usually once daily in the morning, swallowed whole.
  • Eohilia: twice daily, squeezed into the mouth, with no food or drink for 30 minutes afterward.
  • Tarpeyo: once daily in the morning, at least 1 hour before a meal, swallowed whole. If you miss a dose, take the next one on schedule and do not double up.
  • Rectal foam: used only in the rectum.

Dosing details from the FDA-approved label

From the Budesonide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Previous therapy: Bronchodilators alone
    • Recommended starting dose: 0.5 mg total daily dose administered either once daily or twice daily in divided doses (0.5 mg once daily or 0.25 mg twice daily)
    • Maximum: 0.5 mg total daily dose
    • In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered
  • Previous therapy: Inhaled corticosteroids
    • Recommended starting dose: 0.5 mg total daily dose administered either once daily or twice daily in divided doses (0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily)
    • Maximum: 1 mg total daily dose
    • If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose; titrate to the lowest effective dose once asthma stability is achieved
  • Previous therapy: Oral corticosteroids
    • Recommended starting dose: 1 mg total daily dose administered as 0.5 mg twice daily (Pulmicort Respules label also lists 1 mg once daily)
    • Maximum: 1 mg total daily dose
    • Titrate the dose downwards once asthma stability is achieved
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended starting dose and highest recommended dose of budesonide inhalation suspension, 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 Recommendations Dosing recommendations based on previous therapy are as follows: • 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. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. 2.2 Directions for Use Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Budesonide side effects

▾

Common side effects in adults taking budesonide capsules in trials included:

Common side effects

  • Headache
  • Respiratory infection
  • Nausea
  • Back pain
  • Indigestion (dyspepsia)
  • Dizziness
  • Stomach pain
  • Gas, vomiting or tiredness

When to get medical help

  • Get help right away for signs of a severe allergic reaction: rash, hives, swelling, trouble breathing or wheezing.
  • Call your doctor if wheezing gets worse right after a dose (paradoxical bronchospasm).
  • Call your doctor if asthma worsens or does not respond to your usual rescue medicine.
  • Report white patches or soreness in the mouth or throat (possible Candida infection, or thrush).
  • Watch for signs of low adrenal function, such as fatigue, weakness, nausea, vomiting or low blood pressure.
  • Tell your doctor about vision changes, since glaucoma and cataracts have been reported.
  • Report signs of infection, or any exposure to chickenpox or measles.

Steroid-type effects like acne, easy bruising and a rounder face can also occur. Seek help for allergic reactions, worsening wheezing after a dose, signs of infection or adrenal problems.

Budesonide warnings and precautions

▾
  • Immune suppression can worsen infections; chickenpox and measles can be serious or fatal in susceptible people.
  • Mouth and throat yeast infections can occur with inhaled use.
  • Inhaled budesonide does not relieve sudden asthma attacks.
  • High doses over long periods can cause steroid effects and adrenal suppression.
  • Switching from oral steroids needs a slow taper; deaths from adrenal insufficiency have occurred in asthma patients during transfer.
  • Long-term use may lower bone density, slow children’s growth, and cause glaucoma or cataracts.

Budesonide interactions

▾

Budesonide is broken down mainly by the CYP3A4 enzyme, so blockers of it matter.

  • Ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir and telithromycin can raise budesonide levels and steroid effects.
  • Grapefruit juice also blocks CYP3A4; avoid it with budesonide capsules and Uceris tablets.

Interactions listed in the FDA-approved label

From the Budesonide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin): May inhibit the metabolism of, and increase the systemic exposure to, budesonide, which may cause increased systemic corticosteroid effects. Use with caution when considering coadministration with long-term ketoconazole and other known strong CYP3A4 inhibitors.
  • Ketoconazole: After oral administration of ketoconazole, a strong CYP3A4 inhibitor, the mean plasma concentration of orally administered budesonide increased. Caution should be exercised when considering coadministration with long-term ketoconazole.
Read the label’s full interactions text

7 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 P4503A4 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 budesonide inhalation suspension 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 ) ] .

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿154 supplements and herbs with documented Budesonide interactions, ranked by severity Check Budesonide against a supplement or herb →

Before taking Budesonide

▾
  • Do not use if allergic to budesonide or any ingredient.
  • Inhalation suspension is not for primary treatment of status asthmaticus or severe acute asthma.
  • Tell your doctor about tuberculosis, untreated infections or ocular herpes simplex.
  • Avoid exposure to chickenpox or measles if not immune.
  • Tell your doctor if you recently stopped oral steroids.
  • Mention bone loss risk, glaucoma, cataracts or vision changes.
  • Children need growth monitoring on inhaled use.
  • Pregnancy and breastfeeding: discuss with your doctor; budesonide is present in breast milk.

Budesonide overdose

▾

Serious toxicity from a single overdose of glucocorticoids is rare. Too much over a long time can cause steroid effects and adrenal suppression. The label advises getting medical help; treatment is supportive, and for ongoing therapy the dose may be lowered temporarily.

What Budesonide does in the body

▾

Inhaled budesonide works mostly directly in the lungs. Asthma symptoms can improve within 2 to 8 days of starting the nebulized suspension, though full benefit may take 4 to 6 weeks. Corticosteroids can lower the body’s own cortisol and affect adrenal (HPA axis) function, especially at high doses, in young children or with long use.

How your body processes Budesonide

▾

Only about 9% to 21% of oral budesonide reaches the bloodstream, because the liver breaks down most of it on the first pass. It is mostly processed by the CYP3A4 enzyme into metabolites with very little steroid activity. Metabolites leave through urine and feces. With the delayed-release capsules, peak levels come a few hours after dosing, and a high-fat meal delays this slightly.

How to store Budesonide

▾

stored upright at controlled room temperature 20 to 25°C (68 to 77°F) , and protected from light. Keep out of reach of children. Do not freeze.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

154

Supplements & herbs that interact with Budesonide

154 supplements and herbal products have documented interactions with Budesonide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 110
  • Minor · 40
ACTIVATED CHARCOAL Major GRAPEFRUIT Major LILY-OF-THE-VALLEY Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALDER BUCKTHORN Moderate +146 more
Every supplement checked against Budesonide — ranked by severity The full interaction hub: 4 major · 110 moderate · 40 minor · every one linked to its full report. Check Budesonide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

8

Nutrient depletion considerations

Budesonide has been associated with lower levels of 8 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 5
  • Unrated · 2
ZINC Insignificant Depletion CALCIUM Moderate Depletion CHROMIUM Moderate Depletion MAGNESIUM Moderate Depletion POTASSIUM Moderate Depletion VITAMIN D Moderate Depletion SELENIUM Insufficient Evidence STRONTIUM Insufficient Evidence
See the full Budesonide nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Budesonide: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Budesonide — the kind of thing our pharmacy team would talk through with you at the counter.

What is budesonide for?

▾
It calms inflammation. Depending on the product, that means asthma, Crohn’s disease, ulcerative colitis, eosinophilic esophagitis or IgA nephropathy. Your product was chosen for your condition, so take only what was prescribed.

Can I use my budesonide inhaler or nebulizer for a sudden asthma attack?

▾
No. It is for long-term control, not quick relief. If your asthma gets worse and your usual rescue medicine doesn’t help, contact your doctor right away.

How do I keep my mouth healthy with inhaled budesonide?

▾
Rinse your mouth with water after each use and don’t swallow it. This lowers the chance of a yeast infection (thrush). Tell us if you notice white patches or soreness.

Can I drink grapefruit juice?

▾
Avoid it if you take budesonide capsules or Uceris tablets. Grapefruit blocks the enzyme that breaks budesonide down, so more drug can reach your body. Also tell us about antifungals, certain HIV medicines or clarithromycin.

What side effects should I watch for?

▾
Headache, nausea, tiredness and cold-like symptoms are common. Call your doctor for allergic reactions, worse wheezing after a dose, signs of infection, vision changes, or extreme weakness. Avoid chickenpox or measles exposure if you aren’t immune.

Can I stop it suddenly?

▾
Talk to your doctor first. Steroids can affect your adrenal glands, and some products, like Tarpeyo, use a lower dose at the end. Follow the plan your prescriber gives you.

Is Budesonide available over the counter?

▾
Both. Some Budesonide products are sold over the counter and others need a prescription. According to their FDA listings, the nasal spray form is sold over the counter and the inhalation solution (nebulizer), inhaler, capsule, delayed-release capsule, extended-release tablet and oral suspension forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Budesonide first available?

▾
The earliest FDA record we hold for Budesonide is from 1993: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Budesonide was first used.

Who makes Budesonide?

▾
39 companies currently list Budesonide products in the FDA's NDC Directory, including A-S Medication Solutions, American Health Packaging, Amneal Pharmaceuticals of New York LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Budesonide on HelloPharmacist

📊Budesonide supplement interactions154 checked — ranked by severity 🌿Drug & Supplement CheckerBudesonide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Budesonide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Budesonide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Budesonide forms and strengths (how it comes)

Budesonide is available in 7 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Inhalation solution (nebulizer)

Inhaled
Brands Budesonide Inhalation Pulmicort Respules
How this form is used
What it may be used for
  • Pulmicort Respules and budesonide inhalation suspension are for long-term asthma control in children 12 months to 8 years.
  • These products are not for relief of sudden bronchospasm.
Important instructions
  • Budesonide inhalation suspension is for inhalation only; do not swallow it.
  • Use it only with a jet nebulizer connected to an air compressor, not an ultrasonic nebulizer.
  • Pulmicort Respules and budesonide suspension are given once or twice daily depending on prior therapy, per your prescriber.
Available strengths 3 strengths
0.25 mg/2 mL 0.5 mg/2 mL 1 mg/2 mL
45 FDA-listed product records ⓘ

Inhaler

By mouth · Inhaled · Rectal
Brands Pulmicort Pulmicort Flexhaler Uceris
How this form is used
What it may be used for
  • Pulmicort Flexhaler is for long-term asthma control in patients 6 and older, not for sudden bronchospasm.
  • Uceris rectal foam helps bring on remission of mild to moderate distal ulcerative colitis.
Important instructions
  • Pulmicort Flexhaler is used twice daily by oral inhalation only; rinse your mouth with water afterward without swallowing.
  • Prime Pulmicort Flexhaler before first use and inhale deeply and forcefully.
  • Uceris rectal foam is for rectal use only, not by mouth.
  • Warm the Uceris foam canister in your hands and shake it for 10 to 15 seconds before use.
Available strengths 7 strengths
90 mcg 180 mcg 0.25 mg/2 mL 0.5 mg/2 mL 1 mg/2 mL 2 mg
Show 1 more strength Show fewer strengths
28 mg
38 FDA-listed product records ⓘ

Capsule

By mouth
Brands Ortikos
How this form is used
What it may be used for
  • Budesonide delayed-release capsules treat mild to moderate active Crohn’s disease (ileum and/or ascending colon) in patients 8 and older.
  • Budesonide delayed-release capsules help maintain remission of mild to moderate Crohn’s disease for up to 3 months in adults.
Important instructions
  • Budesonide capsules are taken once daily in the morning and swallowed whole.
  • Budesonide capsules can be opened onto applesauce if swallowing is hard; consume within 30 minutes and do not chew.
  • Avoid grapefruit juice while taking budesonide capsules.
Available strengths 1 strength
3 mg
18 FDA-listed product records ⓘ

Nasal spray

In the nose
Available strengths 1 strength
32 mcg
16 FDA-listed product records ⓘ

Delayed-release capsule

By mouth
Brands Tarpeyo
How this form is used
What it may be used for
  • Tarpeyo reduces loss of kidney function in adults with primary IgA nephropathy at risk of progression.
  • Budesonide delayed-release capsules treat mild to moderate active Crohn’s disease in patients 8 and older.
Important instructions
  • Tarpeyo is swallowed whole in the morning, at least 1 hour before a meal. Do not open, crush or chew.
  • Tarpeyo is used for about 9 months, with a lower dose for the last 2 weeks when stopping.
  • If a Tarpeyo dose is missed, take the next dose at the usual time; do not double up.
Available strengths 2 strengths
3 mg 4 mg
10 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Uceris
How this form is used
What it may be used for
  • Uceris extended-release tablets help bring on remission in active, mild to moderate ulcerative colitis.
Important instructions
  • Uceris tablets are taken once daily in the morning, with or without food, for up to 8 weeks.
  • Swallow Uceris whole; do not chew or crush.
  • Avoid grapefruit juice while taking Uceris.
Available strengths 1 strength
9 mg
10 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Eohilia
How this form is used
What it may be used for
  • Eohilia treats eosinophilic esophagitis for 12 weeks in people 11 and older.
Important instructions
  • Eohilia is taken twice daily; do not mix it with food or liquid.
  • Shake the packet for at least 10 seconds, then squeeze it directly into your mouth and swallow all of it.
  • Do not eat or drink for 30 minutes after Eohilia, then rinse your mouth with water and spit.
Available strengths 1 strength
2 mg/10 mL
1 FDA-listed product record ⓘ

Budesonide on the U.S. market: products, makers and brands

How Budesonide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

39 companies list 70 Budesonide product records with the FDA, mostly as inhalation solution (nebulizer), inhaler, capsule; the earliest marketing or approval year on record is 1993. Brand names on the directory include Entocort EC, Tarpeyo, Uceris and 8 more; the rest are generics.

7
Dose forms ⓘ
39
Labelers (makers, repackagers, distributors)
9
Brand names
70
FDA-listed product records ⓘ
1993
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (41) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions11%
American Health Packaging4%
Amneal Pharmaceuticals of New York LLC4%
AstraZeneca Pharmaceuticals LP4%
Cipla USA Inc.4%
Exelan Pharmaceuticals, Inc.4%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Budesonide is used (Medicaid data)

A general measure of how commonly Budesonide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Budesonide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

967,284
Medicaid prescriptions filled (Q1–Q4 2025)
$154.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Budesonide prescribed? Of the 1,601 medications we measure, Budesonide ranks #182 by Medicaid prescriptions — more than 89% of them.

Where Budesonide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #182 of 1,601
#177 Insulin Aspart (rDNA O... 1,003,363 Rx #178 Lisinopril and Hydroch... 999,534 Rx #179 Naloxone 980,072 Rx #180 Oxybutynin 974,653 Rx #181 Naloxone Nasal Spray 970,105 Rx #182 Budesonide 967,284 Rx #183 Ciprofloxacin 959,810 Rx #184 Erythromycin 942,102 Rx #185 Linaclotide 914,996 Rx #186 Iron Sucrose Injection 913,265 Rx #187 Allopurinol 901,974 Rx

Utilization by Budesonide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.25 mg/mL inhalation suspension is the most-dispensed Budesonide product — about 54% of these Medicaid prescriptions.

budesonide 0.25 MG/ML Inhalation Suspension Most dispensed

524,097 Medicaid prescriptions (Q1–Q4 2025) 54% of Budesonide prescriptions shown $43.5M gross reimbursement (before rebates) ≈ $83 per prescription (gross)

Summed across the 14 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351109

budesonide 0.125 MG/ML Inhalation Suspension

226,081 Medicaid prescriptions (Q1–Q4 2025) 23% of Budesonide prescriptions shown $18.7M gross reimbursement (before rebates) ≈ $83 per prescription (gross)

Summed across the 9 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349094

budesonide 0.5 MG/ML Inhalation Suspension

52,509 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $18.3M gross reimbursement (before rebates) ≈ $349 per prescription (gross)

Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 252559

60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler

51,285 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $10.8M gross reimbursement (before rebates) ≈ $211 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966527

budesonide 3 MG Delayed Release Oral Capsule

44,768 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $71 per prescription (gross)

Summed across the 4 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1244214

120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler

39,155 Medicaid prescriptions (Q1–Q4 2025) 4% of Budesonide prescriptions shown $10.7M gross reimbursement (before rebates) ≈ $273 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966522

budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray

20,113 Medicaid prescriptions (Q1–Q4 2025) 2% of Budesonide prescriptions shown $388,554 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797929

24 HR budesonide 9 MG Extended Release Oral Tablet

3,246 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $778 per prescription (gross)

Summed across the 4 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1366550

budesonide 0.2 MG/ML Oral Suspension

3,205 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $5.9M gross reimbursement (before rebates) ≈ $1,842 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2675280

budesonide 4 MG Delayed Release Oral Capsule

2,288 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $39.8M gross reimbursement (before rebates) ≈ $17,381 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2587883

14 ACTUAT budesonide 2 MG/ACTUAT Rectal Foam

537 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $326,563 gross reimbursement (before rebates) ≈ $608 per prescription (gross)

Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596779

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Budesonide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 48 of 170 listed Budesonide NDCs with Medicaid activity.

Compare Budesonide products

A representative set of FDA-listed product records for Budesonide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 70 of 70 products — FDA National Drug Code Directory. See every product, package size and price: browse all 70 Budesonide NDCs →

Budesonide recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Budesonide recalls since July 2021. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II May 29, 2026 · 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
  • Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,… Lots: Lot #: BAG0074A, Exp. Date: 1/31/2027. FDA record D-0607-2026 →
Ongoing Class II Jun 30, 2025 · Cipla USA, Inc.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
  • Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10… Lots: Batch # 4IA0505, Exp 09/31/2026 FDA record D-0541-2025 →
Ongoing Class II Jan 8, 2024 · Teva Pharmaceuticals USA, Inc
Failed Dissolution Specifications
  • Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ… Lots: Lot # 100047273; Exp. 07/2025 FDA record D-0275-2024 →
Class II Sep 15, 2022 · Terminated · CIPLA
Lack of Assurance of Sterility
  • Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured f… Lots: Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024 FDA record D-1545-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Budesonide RxCUI 19831 11 dose forms · 16 strengths
  1. Dose form (SCDF) Delayed Release Oral Capsule RxCUI 1489770 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 1244214 4 MG RxCUI 2587883
  3. Dose form (SCDF) Enema RxCUI 381066 No current FDA listing
  4. Dose form (SCDF) Extended Release Oral Capsule RxCUI 2269304 No current FDA listing
    Clinical drug / strength (SCD) 24 HR budesonide 6 MG RxCUI 2269305 24 HR budesonide 9 MG RxCUI 2269307
  5. Dose form (SCDF) Extended Release Oral Tablet RxCUI 1366549 In current FDA listings
    Clinical drug / strength (SCD) 24 HR budesonide 9 MG RxCUI 1366550
  6. Dose form (SCDF) Inhalation Powder RxCUI 2108302 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG RxCUI 247047
  7. Dose form (SCDF) Inhalation Suspension RxCUI 2108295 In current FDA listings
    Clinical drug / strength (SCD) 0.125 MG/ML RxCUI 349094 0.25 MG/ML RxCUI 351109 0.5 MG/ML RxCUI 252559
  8. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797928 In current FDA listings
    Clinical drug / strength (SCD) 0.032 MG/ACTUAT RxCUI 1797929
  9. Dose form (SCDF) Nasal Spray RxCUI 371152 In current FDA listings
    Clinical drug / strength (SCD) 0.05 MG/ACTUAT RxCUI 247042 0.1 MG/ACTUAT RxCUI 247691
  10. Dose form (SCDF) Oral Suspension RxCUI 2675279 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 2675280

Look up RxCUI 19831 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Budesonide costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Suspension · Respiratory (inhalation) 0.5 mg/2 mL $0.676 per mL NDC details & price history
Suspension · Respiratory (inhalation) 0.25 mg/2 mL $0.697 per mL NDC details & price history
Suspension · Respiratory (inhalation) 1 mg/2 mL $3.43 per mL NDC details & price history
Aerosol, Powder · Respiratory (inhalation) 90 mcg $188.52 each NDC details & price history
Capsule, Coated Pellets · Oral 3 mg $0.498 per capsule NDC details & price history
Inhalant · Oral 0.25 mg/2 mL $0.697 per mL NDC details & price history
Inhalant · Oral 1 mg/2 mL $3.43 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Budesonide brand names

Budesonide is sold under 11 brand names in the FDA directory — Entocort EC, Tarpeyo, Uceris, Rhinocort and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Entocort EC Tarpeyo Uceris Rhinocort Ortikos Eohilia Pulmicort Budesonide Inhalation Pulmicort Flexhaler Budesonide Inhalation Suspension Pulmicort Respules

Who makes Budesonide: manufacturers and labelers

39 companies list Budesonide products with the FDA. By number of product records, the largest are A-S Medication Solutions, American Health Packaging, Amneal Pharmaceuticals of New York LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 8 American Health Packaging 3 Amneal Pharmaceuticals of New York LLC 3 AstraZeneca Pharmaceuticals LP 3 Cipla USA Inc. 3 Exelan Pharmaceuticals, Inc. 3 Preferred Pharmaceuticals Inc. 3 Sun Pharmaceutical Industries, Inc. 3 Teva Pharmaceuticals USA, Inc. 3 Bryant Ranch Prepack 2 Chartwell RX, LLC 2 H2-Pharma LLC 2 Nephron Pharmaceuticals Corporation 2 Oceanside Pharmaceuticals 2 Rising Pharma Holdings, Inc. 2 Rubicon Holdings Inc. 2 Rugby Laboratories 2 Actavis Pharma, Inc. 1 Amneal Pharmaceuticals LLC 1 Apotex Corp. 1 Aurobindo Pharma Limited 1 CVS Pharmacy 1 Calliditas Therapeutics AB 1 Cardinal Health 107, LLC 1

…and 15 more on the FDA NDC directory.

Budesonide drug class (RxNorm)

Budesonide belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
How it works Corticosteroid Hormone Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Budesonide page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Budesonide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Budesonide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
Finished products in the current FDA directory
70
Companies listing them (makers, repackagers, distributors)
39
FDA labeler codes behind them ⓘ
41
Linked representative label ⓘ
Cipla USA Inc.
Linked label effective
Jun 10, 2026
Composite sections available
23
Linked SPL Set ID
c52c5382-1400-44b9-95be-a30e1cf706da
Linked SPL Document ID
29644146-4bcf-49d0-80b3-e31f4b3a6f54
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →