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What the label lists and what reports show

Albuterol and budesonide side effects

Albuterol and budesonide's FDA label: “Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, dysphonia.” FAERS holds 1,374 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device delivery system issue (377 reports).

  • No generic listed

Check it at the source: the albuterol and budesonide FDA label on DailyMed (effective September 18, 2025, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of AIRSUPRA?

AIRSUPRA can cause serious side effects, including: • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine. • heart problems, including faster heart rate and higher blood pressure. • possible death in people who use too much AIRSUPRA. • serious allergic reactions. Tell your healthcare provider or get emergency medical care right away if you have: o skin rash, redness, or swelling o severe itching o swelling of the face, mouth, and tongue o trouble breathing or swallowing o chest pain • changes in laboratory blood levels. Low levels of potassium (hypokalemia) may cause abnormal heart rhythms. […]

Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective September 18, 2025 (SPL set e60aa9f9-5139-44df-b886-ebddc3c7eb13), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, dysphonia.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in labeling: • Deterioration of Asthma [see Warnings and Precautions (5.1) ] • Paradoxical Bronchospasm [see Warnings and Precautions (5.2) ] • Cardiovascular Effects [see Warnings and Precautions (5.3) ] • Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions (5.5) ] • Hypokalemia [see Warnings and Precautions (5.7) ] • Immunosuppression and Risk of Infections [see Warnings and Precautions (5.8) ] • Oropharyngeal Candidiasis [see Warnings and Precautions (5.9) ] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.10) ] • Reduction in Bone Mineral Density [see Warnings and Precautions (5.11) ] • Glaucoma and Cataracts [see Warnings and Precautions (5.12) ] • Effects on Growth in Pediatric Patients [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, dysphonia. ( 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 practice. …

Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective September 18, 2025 (SPL set e60aa9f9-5139-44df-b886-ebddc3c7eb13), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,374 reports list albuterol and budesonide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 97 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. Of the 14 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Device Delivery System Issue377
  • Product Dose Omission Issue (a use or a product term, not a reaction)220
  • Asthma (a use or a product term, not a reaction)160
  • Wrong Technique In Device Usage Process (a use or a product term, not a reaction)150
  • Dyspnoea149
  • Device Malfunction147
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)132
  • Drug Ineffective (a use or a product term, not a reaction)121
  • Device Use Issue117
  • Incorrect Dose Administered By Device (a use or a product term, not a reaction)114
  • Incorrect Dose Administered (a use or a product term, not a reaction)88
  • Cough (named in the label)86
  • Drug Dose Omission By Device (a use or a product term, not a reaction)84
  • Product Use Issue (a use or a product term, not a reaction)79
  • Device Defective62
  • Illness47
  • Headache (named in the label)45
  • Fatigue44
  • Device Issue42
  • Off Label Use (a use or a product term, not a reaction)38
  • Wheezing (named in the label)38
  • Pneumonia37
  • Dysphonia (named in the label)34
  • Overdose (a use or a product term, not a reaction)34
  • Bronchitis30

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Albuterol and budesonide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions