Atrovent (Ipratropium Bromide Monohydrate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse reaction information concerning ATROVENT (ipratropium bromide) Inhalation Aerosol is derived from 90 day controlled clinical trials (N=254), other controlled clinical trials using recommended doses of ATROVENT Inhalation Aerosol (N=377) and an uncontrolled study (N=1924). Additional information is derived from the post-marketing experience and the published literature.

Adverse reactions occurring in greater than one percent of patients in the 90 day controlled clinical trials appear in Table 1.

Table 1 Adverse Reactions Occurring in >1% of COPD Patients

	Percent of Patients
	Ipratropium Bromide	Metaproterenol Sulfate
	N = 254	N= 249
Reaction
Cardiovascular
Palpitations	1.8	1.6
Central Nervous System
Nervousness	3.1	6.8
Dizziness	2.4	2.8
Headache	2.4	2.0
Dermatological
Rash	1.2	0.4
Gastrointestinal
Nausea	2.8	1.2
Gastrointestinal    distress	2.4	2.8
Vomiting	0	1.2
Musculoskeletal
Tremor	0	2.4
Ophthalmological
Blurred vision	1.2	0.8
Oro-Otolaryngeal
Dry mouth	2.4	0.8
Irritation from    aerosol	1.6	1.6
Respiratory
Cough	5.9	1.2
Exacerbation   of symptoms	2.4	3.6

Additional adverse reactions reported in less than one percent of the patients considered possibly due to ATROVENT Inhalation Aerosol include urinary difficulty, fatigue, insomnia and hoarseness.

The large uncontrolled, open-label study included seriously ill patients. About 7% of patients treated discontinued the program because of adverse events.

Of the 2301 patients treated in the large uncontrolled study and in clinical trials other than the 90 day studies, the most common adverse reactions reported were: dryness of the oropharynx, about 5 in 100; cough, exacerbation of symptoms and irritation from aerosol, each about 3 in 100; headache, about 2 in 100; nausea, dizziness, blurred vision/difficulty in accommodation, and drying of secretions, each about 1 in 100. Less frequently reported adverse reactions that were possibly due to ATROVENT (ipratropium bromide) Inhalation Aerosol include tachycardia, paresthesia, drowsiness, coordination difficulty, itching, hives, flushing, alopecia, constipation, tremor, and mucosal ulcers.

Cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, and hypotension, have been reported.

In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and atrial fibrillation occurred with an incidence rate of 0.5% in patients receiving ATROVENT Inhalation Aerosol.

Post-Marketing Experience

Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported, with positive rechallenge in some cases. Many of the patients had a history of allergies to other drugs and/or foods, including soybean. (See CONTRAINDICATIONS).

Additionally, urinary retention, mydriasis, and bronchospasm, including paradoxical bronchospasm, have been reported during the post-marketing period.

REPORTS OF SUSPECTED ATROVENT SIDE EFFECTS / ADVERSE REACTIONS

Possible Atrovent side effects / adverse reactions in 76 year old male

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 76 year old male weighing 102.0 kg (224.4 pounds)

Reactions: Skin Wrinkling, Laceration, Skin Atrophy, Lipoatrophy

Suspect drug(s):
Symbicort
    Dosage: 80/4.5 mcg two puffs twice daily
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-01-01

Nicotine Polacrilex
    Dosage: 1 piece every 2-4 hours as required
    Indication: Nicotine Dependence
    Start date: 2010-07-01

Furosemide
    Administration route: Oral
    Start date: 1999-01-01

Atrovent
    Dosage: two puffs four times a day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-01-01

Folic Acid
    Administration route: Oral
    Start date: 1999-01-01

Metoprolol Tartrate
    Administration route: Oral
    Indication: Cardiac Disorder
    Start date: 1999-01-01

Warfarin Sodium
    Administration route: Oral
    Indication: Coagulopathy
    Start date: 1999-01-01

Pravastatin Sodium
    Administration route: Oral
    Indication: Hypercholesterolaemia
    Start date: 1999-01-01

Vitamin D
    Administration route: Oral
    Start date: 1999-01-01

Possible Atrovent side effects / adverse reactions in 76 year old male

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 76 year old male weighing 102.1 kg (224.5 pounds)

Reactions: Skin Wrinkling, Laceration, Skin Atrophy, Lipoatrophy

Suspect drug(s):
Nicotine Polacrilex
    Indication: Nicotine Dependence
    Start date: 2010-07-01

Pravastatin Sodium
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 1999-01-01

Folic Acid
    Administration route: Oral

Atrovent
    Indication: Chronic Obstructive Pulmonary Disease

Metoprolol Tartrate
    Administration route: Oral
    Indication: Cardiac Disorder
    Start date: 1999-01-01

Furosemide
    Administration route: Oral
    Start date: 1999-01-01

Vitamin D
    Administration route: Oral
    Start date: 1999-01-01

Warfarin Sodium
    Administration route: Oral
    Indication: Anticoagulant Therapy
    Start date: 1999-01-01

Symbicort
    Indication: Chronic Obstructive Pulmonary Disease

Possible Atrovent side effects / adverse reactions in 69 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-08

Patient: 69 year old female

Reactions: Neoplasm Malignant

Adverse event resulted in: life threatening event

Suspect drug(s):
Protelos
    Dosage: 1 sachet, 1x/day
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-01-01

Fenofibrate
    Dosage: 1 df, 1x/day

Xolair
    Dosage: unk (dose reduced)
    Start date: 2009-08-01
    End date: 2010-04-01

Calcium Carbonate
    Dosage: 1 df, 1x/day

Singulair
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Asthma

Aldactone
    Dosage: 25 mg, daily

Bricanyl
    Dosage: 5 mg, 6x/day
    Indication: Asthma
    Start date: 2008-01-01

Pantoprazole Sodium
    Dosage: 40 mg, daily

Prednisone
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Asthma
    Start date: 2006-01-01

Uteplex

Desloratadine
    Dosage: 1 df, 1x/day

Xolair
    Dosage: 300 mg, every two weeks
    Indication: Asthma
    Start date: 2008-07-10
    End date: 2009-08-01

Symbicort
    Dosage: 2 puff/day
    Indication: Asthma
    Start date: 2010-01-01

Xolair
    Dosage: unk (dose increased)
    Start date: 2010-04-01
    End date: 2011-08-05

Atrovent
    Dosage: 0.5 mg, 3x/day
    Indication: Asthma
    Start date: 2008-01-01

Dedrogyl
    Dosage: 3 gtt, 1x/day

Acetaminophen
    Dosage: unk