Prescription medication · Corticosteroid
budesonide
Also sold as Pulmicort, Entocort. This medicine temporarily relieves allergy symptoms.
Data updated 2026-05-15
- 55,389
- FDA reportsOften reported
- 4
- InteractionsFew interactions
- 89% less
- Generic vs brandHuge savings
- 3
- Recall records
What the data shows
budesonide (Pulmicort) is a prescription Corticosteroid, more reported than most tracked drugs (55,389 FDA reports), whose generic runs roughly half the brand price or less (89% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
budesonide (Pulmicort) is a prescription Corticosteroid. This medicine temporarily relieves allergy symptoms.
Budesonide nasal spray is a steroid medicine. It helps to relieve allergy symptoms like sneezing and runny nose.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$4.19/unit
Generic Price
$0.46/unit
Generic Savings
89%
Generic Available
Yes (17 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
What it does
This medicine temporarily relieves allergy symptoms.
Common side effects
Headache, Cough
Key warnings
The growth rate of some children may be slower while using this product.
The sections below are summarized in plain English from budesonide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Budesonide is a corticosteroid. It reduces inflammation in the nasal passages. This helps to relieve allergy symptoms.
How to Take It
Read the instructions inside the package before using. Before the first use, prime the bottle. If you haven't used it in two days, prime it again. Shake the bottle well before each use. For adults and children 12 and older, spray 2 times into each nostril once daily. Once your symptoms get better, reduce to 1 spray in each nostril per day.
This is a plain-language summary of budesonide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Talk to your doctor about the risks and benefits of using budesonide nasal spray during pregnancy. It is not known if budesonide passes into breast milk.
This is a plain-language summary of budesonide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you forget a dose, do not double the next dose. Just take your next dose as scheduled.
This is a plain-language summary of budesonide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store the medicine as directed on the package.
Side Effects (from patient reports)
Based on 55,389 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for budesonide, by number of reports
- Difficulty breathing
Difficulty breathing
6,363 reports
- Asthma
Asthma
4,697 reports
- Tiredness
Tiredness
3,354 reports
- Cough
Cough
3,164 reports
- Headache
Headache
2,978 reports
- Condition getting worse
Condition getting worse
2,696 reports
- Diarrhea
Diarrhea
2,696 reports
- Nausea
Nausea
2,621 reports
- Pneumonia
Pneumonia
2,556 reports
- Wheezing 2,399
Wheezing
2,399 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for budesonide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where budesonide sits
budesonide has more FDA adverse-event reports than 75% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is budesonide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 55,389 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
55,389
Reports Mentioning Death
3,535
6.4% of reports — not proof of cause
Hospitalization Reports
17,576
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 6,364 |
| 4 | ASTHMA | 4,695 |
| 5 | FATIGUE | 3,354 |
| 6 | COUGH | 3,164 |
| 7 | HEADACHE | 2,978 |
| 8 | CONDITION AGGRAVATED | 2,696 |
| 9 | DIARRHOEA | 2,696 |
| 10 | NAUSEA | 2,621 |
| 11 | PNEUMONIA | 2,556 |
| 12 | WHEEZING | 2,399 |
| 13 | MALAISE | 2,194 |
| 14 | PYREXIA | 2,117 |
| 15 | PAIN | 2,104 |
| 16 | WEIGHT DECREASED | 1,961 |
| 17 | ARTHRALGIA | 1,783 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
The growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. Do not spray into eyes or mouth. If allergy symptoms do not improve after two weeks, stop using and talk to a doctor.
Known Drug Interactions
betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone ↑ corticosteroids Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing's syndrome and adrenal suppression.
Mechanism: Darunavir prevents the body from clearing budesonide, which can lead to very high steroid levels in the blood. This increases the risk of your adrenal glands not working properly.
What to do: You should avoid taking these medicines together because of the high risk of serious side effects.
Corticosteroids primarily metabolized by CYP3A betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone ↑ corticosteroid Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression.
Mechanism: The antiviral blocks the natural process your body uses to get rid of budesonide, causing the steroid levels to rise. This can lead to serious side effects like hormone imbalances and adrenal suppression.
What to do: Your doctor may need to monitor you for signs of too much steroid or switch you to a different medication. Report any unusual symptoms to your healthcare provider immediately.
(7.4) 7.1 Inhibitors of Cytochrome P4503A4 The main route of metabolism of corticosteroids, including budesonide, a component of SYMBICORT, 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 CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide.
Mechanism: Certain medications can slow down how your body breaks down budesonide. This causes the drug to stay in your system longer and reach higher levels.
What to do: Your doctor may need to adjust your dosage or watch for signs of increased steroid side effects.
Budesonide (inhalation) a Budesonide (non-inhalation) Ciclesonide (inhalation) Cyclosporine (IV) a Cyclosporine (non-IV) Dexamethasone a Fluticasone (inhalation) a Fluticasone (nasal)Methylprednisolone a Tacrolimus (IV) a Tacrolimus (oral) Monitor for adverse reactions.
Mechanism: Itraconazole can slow down the way your body breaks down this steroid, which may cause the steroid to stay in your system longer than usual.
What to do: Your doctor should monitor you for signs of having too much steroid in your body, such as swelling or mood changes.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
How often should I use this spray?
Can children under 6 use this?
What if my symptoms don't improve?
Can I use this for a cold?
What should I do if I miss a dose?
How should I store this medicine?
Do I need to shake the bottle before using?
What if the spray gets in my eyes?
Can I use this every day?
Should I talk to my doctor before using this?
What are the common side effects of budesonide?
Does budesonide interact with other medications?
What drug class is budesonide?
Is there a generic version of budesonide?
Is budesonide safe during pregnancy?
Has budesonide been recalled?
Active Recalls
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
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA, Inc.
Failed Dissolution Specifications
Teva Pharmaceuticals USA, Inc
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for budesonide
The FDA label for budesonide (sold under brand names such as Pulmicort, Entocort) classifies it as a prescription-only medication in the Corticosteroid class. This medicine temporarily relieves allergy symptoms. Official labeling lists 2 commonly reported side effects, including Headache, Cough.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 55,389 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.46 versus $4.19 for the brand - a 89% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: August 5, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages