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Combivent (Ipratropium Bromide / Albuterol Sulfate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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*
  COMBIVENT
Ipratropium Bromide
36 mcg/Albuterol Sulfate
206 mcg QID
Ipratropium Bromide
36 mcg QID
Albuterol Sulfate
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    
    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 reactions including rash, pruritus, and urticaria (including giant urticaria), angioedema including that of tongue, lips and face, 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 ).

Post-Marketing Experience

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: hypersensitivity, pharyngeal edema, mouth edema, urinary retention, mydriasis, bronchospasm (including paradoxical bronchospasm), cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, intraocular pressure increased, acute eye pain, halo vision, blurred vision, accommodation disorder, ocular irritation, corneal edema, conjunctival hyperaemia, nasal congestion, drying of secretions, mucosal ulcers, stomatitis, irritation from aerosol, throat irritation, dry throat, wheezing, exacerbation of COPD symptoms, hoarseness, palpitations, heartburn, drowsiness, CNS stimulation, coordination difficulty, flushing, alopecia, hypotension, edema, gastrointestinal distress (diarrhea, nausea, vomiting), gastrointestinal motility disorder, constipation, hypokalemia, mental disorder, hyperhidrosis, muscle spasms, muscular weakness, myalgia, asthenia, myocardial ischemia, diastolic blood pressure decreased, and systolic blood pressure increased.

Metabolic acidosis has been reported with use of albuterol-containing products.



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

Suspect drug(s):
Combivent
    Indication: Chronic Obstructive Pulmonary Disease

Combivent
    Indication: Bronchitis
    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

Suspect drug(s):
Combivent

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

Suspect drug(s):
Combivent

Other drugs received by patient: Nebulizer; O2; Flomax; Advair Diskus 100/50



See index of all Combivent side effect reports >>

Drug label data at the top of this Page last updated: 2012-09-20

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