Fluticasone Propionate / Salmeterol Xinafoate

Common brands: Advair Hfa, Ventolin Hfa, Albuterol, Singulair, Spiriva Handihaler

Top reporter: Glaxosmithkline Llc

Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Loop Diuretic [EPC]Provitamin D2 Compound [EPC]
59,090
Total Reports
16,911
Serious Reports
3,539
Death Reports
30
Reported Reactions
Death Report Ratio: High (5.99%)

Patient Demographics

Male
17,683
Female
37,133

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Fluticasone Propionate / Salmeterol Xinafoate.

# Reaction Reports % of Total
1 DYSPNOEA 9,857
10.7%
2 ASTHMA 8,017
8.7%
3 DRUG INEFFECTIVE 5,420
5.9%
4 PNEUMONIA 4,847
5.3%
5 COUGH 4,843
5.3%
6 WHEEZING 4,127
4.5%
7 FATIGUE 3,908
4.3%
8 MALAISE 3,563
3.9%
9 HEADACHE 3,555
3.9%
10 PAIN 3,318
3.6%
11 OFF LABEL USE 2,782
3.0%
12 NAUSEA 2,701
2.9%
13 DIARRHOEA 2,174
2.4%
14 NASOPHARYNGITIS 2,127
2.3%
15 VOMITING 2,121
2.3%
16 DIZZINESS 2,117
2.3%
17 PRODUCTIVE COUGH 2,092
2.3%
18 WEIGHT DECREASED 2,078
2.3%
19 DRUG HYPERSENSITIVITY 1,979
2.2%
20 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1,976
2.2%
21 FALL 1,964
2.1%
22 THERAPEUTIC PRODUCT EFFECT INCOMPLETE 1,935
2.1%
23 PYREXIA 1,925
2.1%
24 RASH 1,890
2.1%
25 ARTHRALGIA 1,846
2.0%
26 CHEST DISCOMFORT 1,842
2.0%
27 DEATH 1,746
1.9%
28 HYPERSENSITIVITY 1,708
1.9%
29 ASTHENIA 1,690
1.8%
30 CONDITION AGGRAVATED 1,684
1.8%

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.