What the label lists and what reports show
Budesonide and formoterol side effects
Budesonide and formoterol's FDA label: “Most common adverse reactions (incidence > 3%) are: • Asthma: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.” FAERS holds 97,711 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 dyspnoea (17,851 reports).
- Generic listed
Check it at the source: the budesonide and formoterol FDA label on DailyMed (effective July 24, 2019, 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 SYMBICORT?SYMBICORT may cause serious side effects, including: • Using too much of a LABA medicine may cause: ∘ chest pain ∘ a fast and irregular heartbeat ∘ tremor ∘ increased blood pressure ∘ headache ∘ nervousness • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using SYMBICORT to help reduce your chance of getting thrush. • Pneumonia and other lower respiratory tract infections. People with COPD have a higher chance of getting pneumonia and other lung infections. Inhaled corticosteroids may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of these symptoms: ∘ increase in mucus (sputum) production ∘ fever ∘ increased cough ∘ change in mucus color ∘ chills ∘ increased breathing problems • Immune system effects and a higher chance for infections. […]
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective July 24, 2019 (SPL set fafa4cf1-99c2-43d5-73ad-51f256de3be0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 3%) are: • Asthma: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
Table 2 Adverse reactions occurring at an incidence of ≥ 3% and more commonly than placebo in the SYMBICORT groups: pooled data from three 12-week, double-blind, placebo-controlled clinical asthma trials in patients 12…
| Adverse Event | 80/4.5 N = 277 % | 160/4.5 N = 124 % | 80 mcg N = 121 % | 160 mcg N = 109 % | 4.5 mcg N = 237 % | N = 400 % |
|---|---|---|---|---|---|---|
| Nasopharyngitis | 10.5 | 9.7 | 14.0 | 11.0 | 10.1 | 9.0 |
| Headache | 6.5 | 11.3 | 11.6 | 12.8 | 8.9 | 6.5 |
| Upper respiratory tract infection | 7.6 | 10.5 | 8.3 | 9.2 | 7.6 | 7.8 |
| Pharyngolaryngeal pain | 6.1 | 8.9 | 5.0 | 7.3 | 3.0 | 4.8 |
| Sinusitis | 5.8 | 4.8 | 5.8 | 2.8 | 6.3 | 4.8 |
| Influenza | 3.2 | 2.4 | 6.6 | 0.9 | 3.0 | 1.3 |
| Back pain | 3.2 | 1.6 | 2.5 | 5.5 | 2.1 | 0.8 |
| Nasal congestion | 2.5 | 3.2 | 2.5 | 3.7 | 1.3 | 1.0 |
| Stomach discomfort | 1.1 | 6.5 | 2.5 | 4.6 | 1.3 | 1.8 |
| Vomiting | 1.4 | 3.2 | 0.8 | 2.8 | 1.7 | 1.0 |
| Oral Candidiasis | 1.4 | 3.2 | 0 | 0 | 0 | 0.8 |
| Average Duration of Exposure (days) | 77.7 | 73.8 | 77.0 | 71.4 | 62.4 | 55.9 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedLABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ]. • Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ]. Systemic and inhaled corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions (5.4) ] • Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions (5.5) ] • Immunosuppression [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Growth effects in pediatric patients [see Warnings and Precautions (5.14) ] • Glaucoma and cataracts [see Warnings and Precautions (5.15) ] 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. Most common adverse reactions (incidence > 3%) are: • Asthma: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. ( 6.1 ) • COPD: nasopharyngitis, oral candidiasis, bronchitis, sinusitis, upper respiratory tract infections.
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective July 24, 2019 (SPL set fafa4cf1-99c2-43d5-73ad-51f256de3be0), via openFDA; the full label on DailyMed
What do FAERS reports show?
97,711 reports list budesonide and formoterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,692 are coded as a death and 28,466 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 16 reactions below, 8 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Budesonide and formoterol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions