Combivent Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/9/2018

Combivent (ipratropium bromide and albuterol sulfate) is an inhaler that is a combination of an anticholinergic bronchodilator and a selective beta2-adrenergic bronchodilator used to treat and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). Side effects of Combivent include:

headache,
dizziness,
nausea,
dry mouth,
shaking (tremors),
nervousness, or
cold symptoms such as stuffy nose, sneezing, cough, or sore throat.

The dose of Combivent Inhalation Aerosol is two inhalations four times a day. Combivent may interact with bladder or urinary medicines, diuretics (water pills), heart or blood pressure medications, medications for Parkinson's disease or depression; medications to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome; other bronchodilators, stimulants, ADHD medications, diet pills, or over-the-counter cold or allergy medicines. Tell your doctor all medications and supplements you use. During pregnancy, this medication should be used only when clearly needed. It is unknown if Combivent is secreted in breast milk. Breastfeeding while using Combivent is not recommended.

Our Combivent Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Asthma is a chronic respiratory disease. See Answer

Combivent Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

wheezing, choking, or other breathing problems after using this medicine;
chest pain;
fast or pounding heartbeats, fluttering in your chest;
tremors, nervousness;
swelling of your ankles or feet;
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
painful or difficult urination; or
low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

headache;
trouble breathing; or
cold symptoms such as stuffy nose, sneezing, cough, or sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow

Combivent Professional Information

SIDE EFFECTS

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 N = 358	Ipratropium Bromide 36 mcg QID N = 362	Albuterol Sulfate 206 mcg QID 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
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
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.

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.

Read the entire FDA prescribing information for Combivent (Ipratropium Bromide and Albuterol Sulfate)