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Spiriva Side Effects

Generic Name: tiotropium

Note: This document contains side effect information about tiotropium. Some of the dosage forms listed on this page may not apply to the brand name Spiriva.

In Summary

Common side effects of Spiriva include: xerostomia. Other side effects include: infection and skin rash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tiotropium: inhalation capsule, inhalation spray

Along with its needed effects, tiotropium (the active ingredient contained in Spiriva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tiotropium:

More common
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • sweating
  • trouble breathing
Less common
  • Cough
  • difficulty with swallowing
  • dizziness
  • hives, itching, or skin rash
  • painful blisters on the trunk of body
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness
Rare
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of tiotropium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chest pain
  • chills
  • congestion
  • cough
  • difficult, burning, or painful urination
  • dry mouth
  • dryness of the throat
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • heartburn
  • hoarseness
  • indigestion
  • loss of voice
  • lower back or side pain
  • pain or tenderness around the eyes and cheekbones
  • runny or stuffy nose
  • sneezing
  • sore throat
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • voice changes
Less common
  • Bloody nose
  • blurred vision
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • lack of appetite
  • leg pain
  • loss of interest or pleasure
  • muscle pain
  • nausea
  • painful or difficult urination
  • sore mouth or tongue
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • sweating
  • swelling or inflammation of the mouth
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unexplained weight loss
  • vomiting
Incidence not known
  • Bloating
  • change in vision
  • diarrhea
  • red skin

For Healthcare Professionals

Applies to tiotropium: inhalation aerosol, inhalation capsule

General

The most commonly reported adverse reaction was dry mouth, usually mild and often resolved during continued treatment.
Other reactions consistent with possible anticholinergic effects included constipation, tachycardia, blurred vision, glaucoma (new onset or worsening), dysuria, and urinary retention.[Ref]

Respiratory

Very common (10% or more): Pharyngitis (11.5%)
Common (1% to 10%): Respiratory tract infection, cough, sinusitis, rhinitis, epistaxis, dysphonia, chest pain, laryngitis
Rare (less than 0.1%): Epistaxis, bronchospasm,
Postmarketing reports: Pharyngolaryngeal pain, throat irritation, hoarseness[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, angina pectoris (including aggravated angina pectoris)
Uncommon (0.1% to 1%): Atrial fibrillation
Rare (less than 0.1%): Palpitations, supraventricular tachycardia, tachycardia[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash
Rare (less than 0.1%): Angioneurotic edema, urticaria, skin infection, skin ulcer, dry skin[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth, constipation, gastroesophageal reflux, oropharyngeal candidiasis, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Dysphagia, gingivitis, intestinal obstruction including ileus paralytic, stomatitis (including ulcerative stomatitis)
Rare (less than 0.1%): Dental caries, glossitis
Frequency not reported: Nausea
Postmarketing reports: Oral candidiasis, throat irritation, mouth ulceration[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention, dysuria[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions
Rare (less than 0.1%): Angioedema, hypersensitivity (including immediate reactions)
Frequency not reported: Anaphylactic reactions[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperglycemia
Frequency not reported: Dehydration[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, skeletal pain, leg pain
Frequency not reported: Join swelling[Ref]

Nervous system

Common (1% to 10%): Dizziness, paresthesia
Uncommon (0.1% to 1%): Headache, insomnia, taste disorder[Ref]

Ocular

Common (1% to 10%): Cataract
Uncommon (0.1% to 1%): Blurred vision
Rare (less than 0.1%): Glaucoma, intraocular pressure increased[Ref]

Other

Common (1% to 10%): Edema, infections, moniliasis, influenza-like symptoms, herpes zoster[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

References

1. "Product Information. Spiriva Respimat (tiotropium)." Boehringer Ingelheim (Canada) Ltd, Burlington, IA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Spiriva (tiotropium)." Boehringer Ingelheim, Ridgefield, CT.

5. "Tiotropium (Spiriva) for COPD." Med Lett Drugs Ther 46 (2004): 41-42

6. Grosso A, Douglas I, Hingorani AD, MacAllister R, Hubbard R, Smeeth L "Inhaled tiotropium bromide and risk of stroke." Br J Clin Pharmacol 68 (2009): 731-6

Some side effects of Spiriva may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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