ADVERSE REACTIONS
Adverse reaction information concerning Combivent Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for Combivent Inhalation Aerosol).
All Adverse Events (in percentages), from Two Large Double-Blind, Parallel, 12-Week Studies of Patients with COPD *
|
|
Combivent
Ipratropium Bromide
36 mcg/Albuterol Sulfate
206 mcg q.i.d. N=358
|
Ipratropium Bromide
36 mcg q.i.d.
N=362
|
Albuterol Sulfate
206 mcg q.i.d.
N=347
|
| Body as A Whole-- General Disorders |
|
Headache
|
5.6
|
3.9
|
6.6
|
|
Pain
|
2.5
|
1.9
|
1.2
|
|
Influenza
|
1.4
|
2.2
|
2.9
|
|
Chest Pain
|
0.3
|
1.4
|
2.9
|
| Gastrointestinal System Disorders |
|
Nausea
|
2.0
|
2.5
|
2.6
|
| Respiratory System Disorders (Lower) |
|
Bronchitis
|
12.3 |
12.4
|
17.9
|
|
Dyspnea
|
4.5
|
3.9
|
4.0
|
|
Coughing
|
4.2
|
2.8
|
2.6
|
|
Respiratory Disorders
|
2.5
|
1.7
|
2.3
|
|
Pneumonia
|
1.4
|
2.5
|
0.6
|
|
Bronchospasm
|
0.3
|
3.9
|
1.7
|
| Respiratory System Disorders (Upper) |
|
Upper Resp. Tract Infection
|
10.9 |
12.7
|
13.0
|
|
Pharyngitis
|
2.2
|
3.3
|
2.3
|
|
Sinusitis
|
2.3
|
1.9
|
0.9
|
|
Rhinitis
|
1.1
|
2.5
|
2.3
|
|
*All adverse events, regardless of drug relationship, reported by two percent or more patients in one or more treatment group in the 12-week controlled clinical trials. |
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Additional adverse reactions, reported in less than two percent of the patients in the Combivent Inhalation Aerosol treatment group include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, and urinary tract infection/dysuria.
Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported, with positive rechallenge in some cases. Many of these patients had a history of allergies to other drugs and/or foods including soybean (See CONTRAINDICATIONS).
Additional information derived from the published literature and post-marketing surveillance on the use of ipratropium or albuterol inhalation aerosol singly or in combination that is not included in the lists above includes: cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, nasal congestion, drying of secretions, mucosal ulcers, irritation from aerosol, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, heartburn, drowsiness, CNS stimulation, coordination difficulty, weakness, itching, flushing, alopecia, hypotension, gastrointestinal distress, constipation, and urinary difficulties.
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