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.
Table 1 All Adverse Events (in percentages), from Two Large Double-blind, Parallel, 12-Week Studies of Patients with COPD*
36 mcg/Albuterol Sulfate
206 mcg QID
36 mcg QID
206 mcg QID
|N = 358||N = 362||N = 347|
|*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 || || |
| Chest Pain||0.3||1.4||2.9|
| Gastrointestinal System Disorders || || |
| Respiratory System Disorders (Lower) || || |
| Respiratory Disorders||2.5||1.7||2.3|
| Respiratory System Disorders (Upper) || || |
| Upper Respiratory Tract Infection||10.9||12.7||13.0|
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® (ipratropium bromide and albuterol sulfate) 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 (see CONTRAINDICATIONS).
In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving Atrovent® (ipratropium bromide) Inhalation Aerosol CFC.
Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: urinary retention, mydriasis, bronchospasm (including paradoxical bronchospasm), cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, ocular irritation, nasal congestion, drying of secretions, mucosal ulcers, irritation from aerosol, wheezing, exacerbation of COPD symptoms, hoarseness, palpitations, heartburn, drowsiness, CNS stimulation, coordination difficulty, flushing, alopecia, itching, hypotension, edema, gastrointestinal distress (diarrhea, nausea, vomiting), constipation, hypokalemia, mental disorder, hyperhidrosis, muscle spasms, muscular weakness, myalgia, and asthenia.
REPORTS OF SUSPECTED COMBIVENT SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Combivent. The information is not vetted and should not be considered as verified clinical evidence.
Possible Combivent side effects / adverse reactions in 68 year old female
Reported by a consumer/non-health professional from United States on 2011-10-03
Patient: 68 year old female
Reactions: Dysgeusia, Throat Irritation
Indication: Chronic Obstructive Pulmonary Disease
Start date: 2006-01-01
Other drugs received by patient: Furosemide; Humalog; Fish OIL; Prilosec; Vitamin TAB; Metoprolol Tartrate; Levemir
Possible Combivent side effects / adverse reactions in 84 year old female
Reported by a consumer/non-health professional from United States on 2011-10-04
Patient: 84 year old female
Reactions: Bronchitis, Cystitis
Other drugs received by patient: Tekturna; Coreg; Coumadin; Synthroid; Diltiazem HCL; Glipizide; Lantus
Possible Combivent side effects / adverse reactions in 69 year old male
Reported by a physician from United States on 2011-10-11
Patient: 69 year old male
Reactions: Dyspnoea, Drug Ineffective, Aortic Calcification, Gastric Cancer
Other drugs received by patient: Nebulizer; O2; Flomax; Advair Diskus 100/50