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Combivent

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Combivent

Combivent

Combivent Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Combivent (ipratropium bromide and albuterol sulfate) is a combination inhaler for that is 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). This product contains 2 medications: ipratropium and albuterol (also known as salbutamol). Both drugs work by relaxing the muscles around the airways.

Side effects can include headache, dizziness, nausea, dry mouth, shaking (tremors), or nervousness. During pregnancy, this medication should be used only when clearly needed. It is unknown if Combivent is secreted in breast milk.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Combivent in Detail - Patient Information: Side Effects

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using albuterol and ipratropium and call your doctor at once if you have any of these serious side effects:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • swelling of your ankles or feet;
  • vision problems, eye pain, or seeing halos around lights;
  • pain or burning with urination; or
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

  • hoarse voice, sore throat, cough, runny or stuffy nose;
  • constipation, diarrhea;
  • nausea, upset stomach;
  • headache; or
  • leg cramps.

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.

Read the entire detailed patient monograph for Combivent (Ipratropium Bromide and Albuterol Sulfate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Combivent Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Headache, dizziness, nausea, dry mouth, shaking (tremors), or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, get medical help right away.

Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes (such as blurred vision, seeing halos), difficult/painful urination, muscle cramps.

Get medical help right away if you have any serious side effects, including: chest pain, fast/pounding/irregular heartbeat.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Combivent (Ipratropium Bromide and Albuterol Sulfate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Combivent FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Combivent - User Reviews

Combivent User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Combivent sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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