Ipratropium Side Effects
Brand Names: Atrovent, Atrovent HFA
Please note - some side effects for Ipratropium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Ipratropium - for the Consumer
Ipratropium Aerosol Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ipratropium Aerosol Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Ipratropium Aerosol Suspension:Cough; dizziness; dry mouth; dry nose or nose irritation; flu-like symptoms; headache; nausea; nervousness; pain; runny nose; sinus infection; sore throat; upper respiratory tract infection.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; eye pain; nosebleeds; trouble urinating; visual halos or colored rings.
Ipratropium Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ipratropium Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Ipratropium Solution:Cough; dizziness; dry mouth; dry nose or nose irritation; flu-like symptoms; headache; nausea; nervousness; pain; upper respiratory tract infection; runny nose; sinus infection; sore throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; eye pain; nosebleeds; trouble urinating.
Ipratropium Spray
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ipratropium Spray:
Seek medical attention right away if any of these SEVERE side effects occur when using Ipratropium Spray:Dry nose or nose irritation; mild nosebleed; nausea; sore throat.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; eye pain; fast heartbeat; hoarseness; severe constipation; severe or recurring nosebleeds; severe nasal dryness; sinus infection; trouble urinating; visual halos or colored rings.
Ipratropium Side Effects - for the Professional
Ipratropium
Adverse reaction information concerning Ipratropium Bromide Inhalation Solutions is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign postmarketing experience and the published literature.
All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.
Additional adverse reactions reported in less than three percent of the patients treated with Ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma and acute eye pain have been reported.
Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of Ipratropium bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of Ipratropium bromide equals or exceeds 2,000 mcg.
Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.
All Adverse Events, from a Double-blind, Parallel, 12-week Study of Patients with COPD*
| Ipratropium Bromide (500 mcg t.i.d) n=219 |
Metaproterenol (15 mg t.i.d) n=212 |
Ipratropium Bromide/ Metaproterenol (500 mg t.i.d/15 mg t.i.d) n=108 |
Albuterol (2.5 mg t.i.d) n=205 |
Ipratropium Bromide/ Albuterol (500 mcg t.i.d. 2.5 mg t.i.d) n=100 |
|
| *All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials. | |||||
| Body as a Whole-General Disorders | |||||
| Headache | 6.4 | 5.2 | 6.5 | 6.3 | 9.0 |
| Pain | 4.1 | 3.3 | 0.9 | 2.9 | 5.0 |
| Influenza-like symptoms | 3.7 | 4.7 | 6.5 | 0.5 | 1.0 |
| Back Pain | 3.2 | 1.9 | 1.9 | 2.4 | 0.0 |
| Chest Pain | 3.2 | 4.2 | 5.6 | 2.0 | 1.0 |
| Cardiovascular Disorders | |||||
| Hypertension/Hypertension Aggravated | 0.9 | 1.9 | 0.9 | 1.5 | 4.0 |
| Central & Peripheral Nervous System | |||||
| Dizziness | 2.3 | 3.3 | 1.9 | 3.9 | 4.0 |
| Insomnia | 0.9 | 0.5 | 4.6 | 1.0 | 1.0 |
| Tremor | 0.9 | 7.1 | 8.3 | 1.0 | 0.0 |
| Nervousness | 0.5 | 4.7 | 6.5 | 1.0 | 1.0 |
| Gastrointestinal System Disorders | |||||
| Mouth Dryness | 3.2 | 0.0 | 1.9 | 2.0 | 3.0 |
| Nausea | 4.1 | 3.8 | 1.9 | 2.9 | 2.0 |
| Constipation | 0.9 | 0.0 | 3.7 | 1.0 | 1.0 |
| Musculo-skeletal System Disorders | |||||
| Arthritis | 0.9 | 1.4 | 0.9 | 0.5 | 3.0 |
| Respiratory System Disorders (Lower) | |||||
| Coughing | 4.6 | 8.0 | 6.5 | 5.4 | 6.0 |
| Dyspnea | 9.6 | 13.2 | 16.7 | 12.7 | 9.0 |
| Bronchitis | 14.6 | 24.5 | 15.7 | 16.6 | 20.0 |
| Bronchospasm | 2.3 | 2.8 | 4.6 | 5.4 | 5.0 |
| Sputum Increase | 1.4 | 1.4 | 4.6 | 3.4 | 0.0 |
| Respiratory Disorder | 0.0 | 6.1 | 6.5 | 2.0 | 4.0 |
| Respiratory System Disorder (Upper) | |||||
| Upper Respiratory Tract Infection | 13.2 | 11.3 | 9.3 | 12.2 | 16.0 |
| Pharyngitis | 3.7 | 4.2 | 5.6 | 2.9 | 4.0 |
| Rhinitis | 2.4 | 4.2 | 1.9 | 2.4 | 0.0 |
| Sinusitis | 2.3 | 2.8 | 0.9 | 5.4 | 4.0 |
Side Effects by Body System
General
Ipratropium has been generally well-tolerated, and void of systemic effects when administered intranasally.
Local
Local side effects have included blood-tinged mucus (17%), nasal dryness (10%), epistaxis (7%), and nasal irritation (2%).
Nervous system
Nervous system side effects have included headache is reported in approximately 9% of the patients treated with the nasal spray. Dizziness has occurred infrequently.
Hypersensitivity
Hypersensitivity side effects have included reports of allergic-type reactions including skin rash, angioedema of the throat, tongue, lips,and face, generalized urticaria, laryngospasm, and anaphylactic reactions.
Ocular
Ocular side effects have included blurred vision and conjunctivitis after the medication came in contact with the eyes.
Genitourinary
Genitourinary side effects have not been usually observed with the low doses given by nasal spray. Urinary retention has been reported occasionally in patients receiving larger doses by nebulizer. Caution may be warranted when using ipratropium in men with prostatic hypertrophy.
Respiratory
Respiratory side effects have included pharyngitis and upper respiratory tract infection has been reported in 8% and 9% of patients, respectively.
Cardiovascular
Cardiovascular side effects have included rare reports of tachycardia and palpitations.
Gastrointestinal
Gastrointestinal side effects have included nausea and diarrhea.
Dermatologic
Dermatologic side effects have included rare reports of skin rash.
TopMore Ipratropium resources
- ipratropium Inhalation, oral/nebulization Advanced Consumer (Micromedex) - Includes Dosage Information
- Ipratropium Prescribing Information (FDA)
- Ipratropium Aerosol Suspension Medfacts Consumer Leaflet (Wolters Kluwer)
- Atrovent Detailed Consumer Information (PDR)
- Atrovent Consumer Overview
- Atrovent Aerosol Suspension Medfacts Consumer Leaflet (Wolters Kluwer)
- Atrovent HFA Prescribing Information (FDA)
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