Combivent Side Effects
Please note - some side effects for Combivent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Combivent - for the consumer
Combivent Aerosol
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Combivent Aerosol:
Seek medical attention right away if any of these SEVERE side effects occur when using Combivent Aerosol:Coughing; dizziness; dry mouth; headache; nervousness; sinus inflammation; sore throat.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsening breathing problems; pounding in the chest; shortness of breath; swelling of the arms or legs; tremors; unexplained hoarseness; wheezing.
For the professional
Combivent
Adverse reaction information concerning Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for Combivent Inhalation Aerosol) as seen in Table 1.
| Combivent Ipratropium Bromide 36 mcg/Albuterol Sulfate 206 mcg QID N=358 |
Ipratropium Bromide 36 mcg QID N=362 |
Albuterol Sulfate 206 mcg QID N=347 |
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|---|---|---|---|
*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. | |||
| Body as A Whole- General Disorders |
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| 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 Respiratory 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 |
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 Combivent Inhalation Aerosol, with positive rechallenge in some cases. Many of these patients had a history of allergies to other drugs and/or foods including soybean.
TopMore resources:
Combivent Inhalation-Local - Includes detailed dosage instructions.
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