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Atrovent HFA

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Atrovent HFA

Atrovent HFA Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Atrovent HFA (ipratropium bromide HFA) is an anticholinergic bronchodilator, packaged in an inhaler, used for dose for maintenance and treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, and emphysema. Atrovent HFA is available as a generic termed ipratropium bromide. Common side effects of Atrovent HFA are headache, dry mouth, hoarseness, cough, nausea, blurred vision, and dizziness. The "HFA" is an acronym that means hydrofluoroalkane, the propellant that pushes out the puff or spray from inside the inhaler.

Atrovent HFA is available as a pressurized metered-dose aerosol unit for oral inhalation that contains a solution of ipratropium bromide. Severe side effects of Atrovent HFA may include shortness of breath, swelling of face, lips, tongue or throat, rapid heartbeats, urinary retention, and glaucoma. Patients that are hypersensitive to atropine should not be given Atrovent HFA. There are no well controlled studies of Atrovent HFA in pregnancy or in women who are breastfeeding, or in the pediatric population; use of Atrovent HFA with these patients requires risks versus benefits be considered by the doctor and patient.

Our Atrovent HFA 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.

Atrovent HFA in Detail - Patient Information: Side Effects

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

Stop using ipratropium and call your doctor at once if you have a side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • blurred vision, eye pain, or seeing halos around lights;
  • pain or burning when you urinate;
  • urinating less than usual or not at all; or
  • worsening of your symptoms.

Other common side effects may include:

  • headache, dizziness;
  • stuffy nose, sinus pain, dry mouth, cough, hoarseness;
  • nausea, upset stomach, constipation;
  • back pain; or
  • fever, chills, body aches, flu symptoms.

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 Atrovent HFA (Ipratropium Bromide Inhalation Aerosol) »

What is Patient Information Overview?

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

Atrovent HFA Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Dizziness, nausea, stomach upset, dry mouth, or constipation 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, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including: vision changes, eye pain, fast/pounding heartbeat, difficult/painful urination.

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 Atrovent HFA (Ipratropium Bromide Inhalation Aerosol)»

What is Prescribing information?

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

Atrovent HFA FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.

Clinical Trials Experience

The adverse reaction information concerning ATROVENT HFA is derived from two 12-week, double-blind, parallel group studies and one 1-year open-label, parallel group study. These studies compared ATROVENT HFA Inhalation Aerosol, ATROVENT CFC Inhalation Aerosol, and placebo (in one study only) in 1010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group and greater than placebo in the 12-week study. The frequency of corresponding reactions in the 1-year open label study is included for comparison.

TABLE 1 : Adverse Reactions (% Patients) in ATROVENT HFA Clinical Trials

  Placebo-controlled 12 week Study 244.1405 and Active-controlled 12 week Study 244.1408 Active-controlled 1-year Study 244.2453
Atrovent HFA
(N=243)
%
Atrovent CFC
(N=183)
%
Placebo
(N=128)
%
Atrovent HFA
(N=305)
%
Atrovent CFC
(N=151)
%
BODY AS A WHOLE - GENERAL DISORDERS
  Back pain 2 3 2 7 3
  Headache 6 9 8 7 5
  Influenza-like symptoms 4 2 2 8 5
CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS
  Dizziness 3 3 2 3 1
GASTROINTESTINAL SYSTEM DISORDERS
  Dyspepsia 1 3 1 5 3
  Mouth dry 4 2 2 2 3
  Nausea 4 1 2 4 4
RESPIRATORY SYSTEM DISORDERS
  Bronchitis 10 11 6 23 19
  COPD exacerbation 8 14 13 23 23
  Dyspnea 8 8 4 7 4
  Sinusitis 1 4 3 11 14
URINARY SYSTEM DISORDERS
  Urinary tract infection 2 3 1 10 8

Cough, rhinitis, and upper respiratory infection occurred in greater than or equal to 3% of patients in either ipratropium treatment group but not greater than placebo in the 12-week study.

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between ATROVENT HFA and ATROVENT CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ATROVENT HFA and 8.7% of the patients taking 42 mcg ATROVENT CFC reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of ATROVENT HFA and 0.9% of ATROVENT CFC patients), and taste perversion (bitter taste) (0.9% of ATROVENT HFA and 0.3% of ATROVENT CFC patients).

As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, halo vision, conjunctival hyperaemia, corneal edema, mydriasis, acute eye pain, dry throat, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported with the use of ATROVENT. Additional adverse reactions identified for ATROVENT seen in clinical trials include throat irritation, stomatitis, mouth edema, and vision blurred.

Allergic-type reactions such as skin rash, pruritus, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported [see WARNINGS AND PRECAUTIONS].

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 CFC.

In addition to the adverse reactions reported in the controlled clinical trials, adverse reactions have been identified during post approval use of ATROVENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic-type reactions such as skin rash, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.

Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), cough and bronchospasm, including paradoxical bronchospasm, hypersensitivity reactions, intraocular pressure increased, accommodation disorder, heart rate increased, pharyngeal edema, and gastrointestinal motility disorders have been reported during the post-marketing period with use of ATROVENT.

Read the entire FDA prescribing information for Atrovent HFA (Ipratropium Bromide Inhalation Aerosol) »

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Atrovent HFA - User Reviews

Atrovent HFA User Reviews

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Here is a collection of user reviews for the medication Atrovent HFA 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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