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

Applies to tiotropium: inhalation capsule, inhalation spray.

Serious side effects of Spiriva Respimat

Along with its needed effects, tiotropium (the active ingredient contained in Spiriva Respimat) 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

Other side effects of Spiriva Respimat

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]