Prednisolone vs Budesonide and Formoterol: side effects in FDA adverse event reports
At a glance
| Prednisolone | Budesonide and Formoterol | |
|---|---|---|
| Drug class | Corticosteroid | Corticosteroid |
| Brand names | – | Pulmicort Flexhaler |
| FAERS reports | 179,389 | 96,445 |
| Serious | 96% | 61% |
| Death outcome | 28,710 | 6,674 |
| Boxed warning | No | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Prednisolone
- Nocardiosis — n=550, PRR 31.8 Labeled (related wording)
- Bk virus infection — n=535, PRR 22.1 Labeled (related wording)
- Varicella zoster virus infection — n=387, PRR 26.8 Labeled (related wording)
- Hepatitis e — n=378, PRR 36.9 Labeled (related wording)
- Steroid diabetes — n=373, PRR 40.0 Labeled (related wording)
- Jc virus infection — n=284, PRR 25.1 Labeled (related wording)
- Infection reactivation — n=207, PRR 25.6 Labeled (related wording)
- Epstein-barr virus infection reactivation — n=199, PRR 21.7 Labeled (related wording)
Labeled signals distinctive to Budesonide and Formoterol
- Wheezing — n=5,738, PRR 23.3 Labeled adverse reaction
- Asthmatic crisis — n=442, PRR 29.8 Labeled (related wording)
- Pulmonary function test decreased — n=392, PRR 21.2 Labeled (related wording)
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=116, PRR 62.2 Labeled (related wording)
Common questions
Which has more reported side effects, Prednisolone or Budesonide and Formoterol?
Prednisolone has 179,389 FAERS reports and Budesonide and Formoterol 96,445. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (96% vs 61%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Prednisolone and Budesonide and Formoterol share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Prednisolone or Budesonide and Formoterol safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.