Budesonide / Formoterol Fumarate Dihydrate

Common brands: Symbicort, Ventolin Hfa, Spiriva Handihaler, Albuterol, Prednisone

Top reporter: Astrazeneca Pharmaceuticals Lp

Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Proton Pump Inhibitor [EPC]Loop Diuretic [EPC]Benzodiazepine [EPC]
95,178
Total Reports
31,332
Serious Reports
6,631
Death Reports
30
Reported Reactions
Death Report Ratio: High (6.97%)

Patient Demographics

Male
31,540
Female
56,062

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Budesonide / Formoterol Fumarate Dihydrate.

# Reaction Reports % of Total
1 DYSPNOEA 17,587
12.9%
2 ASTHMA 11,965
8.8%
3 COUGH 7,830
5.7%
4 DRUG INEFFECTIVE 6,733
4.9%
5 OFF LABEL USE 5,866
4.3%
6 PNEUMONIA 5,750
4.2%
7 WHEEZING 5,696
4.2%
8 FATIGUE 5,338
3.9%
9 MALAISE 4,564
3.3%
10 HEADACHE 4,497
3.3%
11 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 4,017
2.9%
12 NAUSEA 3,947
2.9%
13 DEATH 3,782
2.8%
14 DRUG DOSE OMISSION 3,643
2.7%
15 INTENTIONAL PRODUCT MISUSE 3,552
2.6%
16 PAIN 3,284
2.4%
17 DIZZINESS 3,281
2.4%
18 DIARRHOEA 3,105
2.3%
19 CHEST DISCOMFORT 3,019
2.2%
20 THERAPEUTIC PRODUCT EFFECT INCOMPLETE 2,960
2.2%
21 WEIGHT DECREASED 2,847
2.1%
22 PRODUCT DOSE OMISSION ISSUE 2,799
2.0%
23 NASOPHARYNGITIS 2,768
2.0%
24 DEVICE MALFUNCTION 2,712
2.0%
25 PRODUCTIVE COUGH 2,643
1.9%
26 ASTHENIA 2,567
1.9%
27 ARTHRALGIA 2,564
1.9%
28 FALL 2,535
1.9%
29 VOMITING 2,411
1.8%
30 BRONCHITIS 2,341
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.