Learn more about reported common adverse reactions
Experience with TRELEGY in COPD and in ASTHMA
Adverse Reactions in COPD Adverse Reactions in ASTHMA
TRELEGY in COPD: data from two 12-week studies and a 52-week long-term study
Across two 12-week studies in subjects with COPD, the most commonly reported adverse reactions with ≥1% incidence and more common than BREO were:
TRELEGY |
BREO |
|
Nervous system disorders | ||
Headache Dysgeusia |
4 2 |
3 <1 |
Musculoskeletal & connective tissue disorders | ||
Back pain |
4 |
2 |
Respiratory, thoracic, & mediastinal disorders | ||
Cough Oropharyngeal pain |
1 1 |
<1 0 |
GI disorders | ||
Diarrhea |
2 |
<1 |
Infections & infestations | ||
Gastroenteritis |
1 |
0 |
Long-term safety data: 52-week study in subjects with COPD
In addition to the adverse reactions shown in table above, adverse reactions occurring in ≥1% of the subjects with COPD treated with TRELEGY 100/62.5/25 (n=4151) for up to 52 weeks also included URTI, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, UTI, and dysphonia.
TRELEGY in ASTHMA: data from a study of 24 to 52 weeks’ duration
Table below shows adverse reactions for TRELEGY 100/62.5/25 vs BREO 100/25.
See adverse reactions for TRELEGY 200/62.5/25 vs BREO 200/25 in next table.
To view all treatment groups in one chart, see Table 3 in Prescribing Information
Adverse reactions in subjects with ASTHMA ≥1% incidence in the CAPTAIN study
Adverse reactions in subjects with ASTHMA ≥1% incidence in the CAPTAIN study
TRELEGY |
TRELEGY |
BREO |
BREO |
|
Infections & infestations |
||||
Pharyngitis/nasopharyngitis URTI/viral URTI Bronchitis RTI/viral RTI Sinusitis/acute sinusitis UTI Rhinitis Influenza Pneumonia |
15 7 5 3 3 2 1 1 <1 |
17 5 4 4 2 <1 2 4 1 |
16 6 5 2 2 <1 2 2 2 |
16 7 3 4 3 1 3 3 2 |
Nervous system disorders | ||||
Headache |
5 |
9 |
6 |
7 |
Musculoskeletal & connective tissue disorders | ||||
Back pain |
2 |
3 |
1 |
4 |
Respiratory, thoracic, & mediastinal disorders | ||||
Dysphonia Oropharyngeal pain Cough |
1 1 1 |
1 1 <1 |
2 <1 1 |
1 <1 1 |
TRELEGY |
BREO |
|
Infections & infestations | ||
Pharyngitis/nasopharyngitis |
17 | 16 |
URTI/viral URTI | 5 | 7 |
Bronchitis | 4 | 3 |
RTI/viral RTI | 4 | 4 |
Sinusitis/acute sinusitis |
2 | 3 |
UTI | <1 | 1 |
Rhinitis | 2 | 3 |
Influenza | 4 | 3 |
Pneumonia | 1 | 2 |
Nervous system disorders | ||
Headache |
9 |
7 |
Musculoskeletal & connective tissue disorders | ||
Back pain |
3 |
4 |
Respiratory, thoracic, & mediastinal disorders | ||
Dysphonia | 1 | 1 |
Oropharyngeal pain |
1 | <1 |
Cough | <1 | 1 |
Table below shows adverse reactions for TRELEGY 200/62.5/25 vs BREO 200/25.
See adverse reactions for TRELEGY 100/62.5/25 vs BREO 100/25 in previous table.
To view all treatment groups in one chart, see Table 3 in Prescribing Information
Adverse reactions in subjects with ASTHMA ≥1% incidence in the CAPTAIN study
TRELEGY |
BREO |
|
Infections & infestations | ||
Pharyngitis/nasopharyngitis |
15 | 16 |
URTI/viral URTI | 7 | 6 |
Bronchitis | 5 | 5 |
RTI/viral RTI | 3 | 2 |
Sinusitis/acute sinusitis |
3 | 2 |
UTI | 2 | <1 |
Rhinitis | 1 | 2 |
Influenza | 1 | 2 |
Pneumonia | <1 | 2 |
Nervous system disorders | ||
Headache |
5 |
6 |
Musculoskeletal & connective tissue disorders | ||
Back pain |
2 |
1 |
Respiratory, thoracic, & mediastinal disorders | ||
Dysphonia | 1 | 2 |
Oropharyngeal pain |
1 | <1 |
Cough | 1 | 1 |
Once-daily TRELEGY provides triple therapy with simplified delivery in a single inhaler.