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Budesonide And Formoterol Fumarate Dihydrate

Also sold as Budesonide and Formoterol Fumarate Dihydrate

Medicine summary · from official FDA labels · Oct 19, 2026

7 recalls on record — a recall affects specific batches; check with your pharmacist.

What it’s used for

1 INDICATIONS AND USAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.

How to take it

For oral inhalation only. • Treatment of asthma in patients 12 years and older: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.

Important warnings

5 WARNINGS AND PRECAUTIONS • Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk. ( 5.

Common side effects

6 ADVERSE REACTIONS LABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5. 1) ].

Interactions

In clinical studies, concurrent administration of budesonide and formoterol fumarate dihydrate and other drugs, such as short-acting beta 2 -agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions.

If pregnant or breastfeeding

8.

Forms & strengths

3 MG Delayed Release Oral Capsule · 0.032 MG/ACTUAT Nasal Spray · 0.05 MG/ACTUAT Nasal Spray · 0.1 MG/ACTUAT Nasal Spray · 4 MG Delayed Release Oral Capsule · 0.2 MG/ML Oral Suspension

Questions to ask your doctor or pharmacist

  • Is this the right medicine for my condition, and how long should I take it?
  • What side effects should I watch for, and which need urgent attention?
  • Does this interact with my other medicines, supplements, or alcohol?
  • What should I do if I miss a dose or take too much?