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Spiriva Side Effects

Common Spiriva Side Effects

The most commonly reported Spiriva side effects (click to view or check a box to report):

Dyspnoea (2211)
Product Quality Issue (1652)
Dry Mouth (612)
Cough (534)
Pneumonia (495)
Chronic Obstructive Pulmonary Disease (376)
Off Label Use (365)
Dysphonia (321)
Dizziness (253)
Vision Blurred (252)
Constipation (243)
Chest Discomfort (214)
Headache (206)
Fatigue (192)
Chest Pain (184)
Ageusia (180)
Asthenia (178)
Nausea (176)
Bronchitis (171)
Fall (168)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Spiriva Side Effects Reported to FDA

The following Spiriva reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Spiriva on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Visual Acuity Reduced, Amnesia, Weight Decreased
on Mar 12, 2014 Male from US , weighting 185.2 lb, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: visual acuity reduced, amnesia, weight decreased. Spiriva dosage: 18 Mcg.
Associated medications used:
  • Advair Diskus (Fomulation: Inhalation Spray; Strength: 500/50 Mcg; Daily Dose: 1000/100 Mcg)


Dry Eye, Thirst, Abnormal Faeces, Faeces Hard, Constipation, Dry Mouth, Lip Dry, Off Label Use
Patient was taking Spiriva. Patient felt the following Spiriva side effects: dry eye, thirst, abnormal faeces, faeces hard, constipation, dry mouth, lip dry, off label use on Mar 12, 2014 from US Additional patient health information: Male , 49 years of age, weighting 165.3 lb, was diagnosed with and. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Advair Diskus (Formulation: Inhalation Spray, Strength: 500/50 Mcg; Daily Dose: 1000/100 Mcg)
  • Montelukast (10 Mg)
  • Guaifenesin (800 Mg)
  • Fluticasone (50 Mcg)


Dry Skin, Pallor, Rash Erythematous
Adverse event was reported on Mar 12, 2014 by a Female taking Spiriva (Dosage: 1 Anz) . Location: CA , 54 years of age, After Spiriva was administered, patient encountered several Spiriva side effects: dry skin, pallor, rash erythematous.
Multiple concurrent drugs taken:
  • Advair
  • Perindopril
  • Ranitidine
  • Salbutamol


Infectious Pleural Effusion, Lung Abscess, Pneumonia
on Mar 12, 2014 Male from CA , 64 years of age, was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: infectious pleural effusion, lung abscess, pneumonia. Spiriva dosage: N/A.
Associated medications used:
  • Advair
  • Enbrel (7.1429 Mg)
  • Methotrexate (2.8571 Mg)
  • Salbutamol
  • Prednisone (40 Mg)
Patient was hospitalized.


Hip Fracture
on Mar 11, 2014 Female from US , 71 years of age, weighting 121.3 lb, was diagnosed with and was treated with Spiriva. Patient felt the following Spiriva side effects: hip fracture. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Metformin
  • Pletal
  • Plavix
  • Hydrochlorothiazide
  • Tricor
  • Wellbutrin
  • Gabapentin
  • Simvastatin
Patient was hospitalized.

Myocardial Infarction, Dizziness
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: myocardial infarction, dizziness on Mar 11, 2014 from US Additional patient health information: Female , 65 years of age, was diagnosed with and. Spiriva dosage: 18 Mcg. Patient was hospitalized.

Lumbar Vertebral Fracture, Upper Respiratory Tract Infection
Adverse event was reported on Mar 11, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , weighting 189.6 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: lumbar vertebral fracture, upper respiratory tract infection.
Associated medications used:
  • Norco
  • Oxycontin (20 Mg)
  • Dulera ((inhalation Aerosol))
Patient was hospitalized.

Muscle Spasms
on Mar 11, 2014 Female from US , 76 years of age, weighting 246.9 lb, was diagnosed with and was treated with Spiriva. Patient felt the following Spiriva side effects: muscle spasms. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Symbicort (4 Puf)
  • Norvasc (10 Mg)
  • Losartin (100 Mg)
  • Metaprolol Er (100 Mg)


Paraesthesia, Dry Mouth, Off Label Use
on Mar 11, 2014 Female from US , 83 years of age, weighting 149.9 lb, was diagnosed with and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: paraesthesia, dry mouth, off label use. Spiriva dosage: 18 Mcg.

Off Label Use
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: off label use on Mar 11, 2014 from US Additional patient health information: Male , 75 years of age, weighting 209.4 lb, was diagnosed with and. Spiriva dosage: 18 Mcg.

Off Label Use
Adverse event was reported on Mar 11, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , 34 years of age, Patient felt the following Spiriva side effects: off label use.

Off Label Use
on Mar 11, 2014 Female from US , 48 years of age, was diagnosed with and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: off label use. Spiriva dosage: 18 Mcg.

Arthritis, Bone Disorder, Candida Infection, Chest Pain, Choking, Condition Aggravated, Decreased Appetite, Dyspnoea, Fear Of Eating
on Mar 11, 2014 Female from CA , 66 years of age, was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: arthritis, bone disorder, candida infection, chest pain, choking, condition aggravated, decreased appetite, dyspnoea, fear of eating. Spiriva dosage: N/A.
Associated medications used:
  • Advair Diskus
  • Advair Diskus (Dose Per Application Unit: Dosage Forms)
  • Advair Diskus
  • Advair Diskus
  • Ventolin (Dose Per Application Unit: Dosage Forms)
  • Morphine


Anxiety
Patient was taking Spiriva. Patient felt the following Spiriva side effects: anxiety on Mar 11, 2014 from US Additional patient health information: Male , 60 years of age, was diagnosed with and. Spiriva dosage: 18 Mcg.

Malaise, Product Quality Issue
Adverse event was reported on Mar 11, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , 75 years of age, After Spiriva was administered, patient encountered several Spiriva side effects: malaise, product quality issue.

Vision Blurred, Off Label Use
on Mar 11, 2014 Male from US , 63 years of age, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: vision blurred, off label use. Spiriva dosage: 18 Mcg.

Dry Eye, Thirst, Dry Mouth, Abdominal Distension, Infrequent Bowel Movements, Dysuria, Abnormal Faeces, Proctalgia, Intestinal Obstruction
on Mar 07, 2014 Male from US , 49 years of age, weighting 165.0 lb, was diagnosed with and was treated with Spiriva. Patient felt the following Spiriva side effects: dry eye, thirst, dry mouth, abdominal distension, infrequent bowel movements, dysuria, abnormal faeces, proctalgia, intestinal obstruction. Spiriva dosage: 2 Puffs.
Multiple prescriptions taken:
  • Sluticasone Propionate
  • Montelukast Sod
  • Guaiifenesin


Prescribed Overdose, Off Label Use
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: prescribed overdose, off label use on Mar 10, 2014 from US Additional patient health information: Male , 61 years of age, was diagnosed with and. Spiriva dosage: 36 Mcg.

Arthritis, Chronic Obstructive Pulmonary Disease
Adverse event was reported on Mar 10, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , weighting 209.4 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: arthritis, chronic obstructive pulmonary disease.
Associated medications used:
  • Synmbicort (Formulation: Inhalation Aerosol)
  • Neurotin
  • Vesicare
  • Albuterol (Formulation: Inhalation Aerosol)
  • Allopurinol
Patient was hospitalized.

Condition Aggravated, Dyspnoea, Musculoskeletal Stiffness, Neck Pain, Pneumonia, Insomnia, Musculoskeletal Pain, Arthralgia, Arthritis
on Mar 10, 2014 Male from CA , 75 years of age, was treated with Spiriva. Patient felt the following Spiriva side effects: condition aggravated, dyspnoea, musculoskeletal stiffness, neck pain, pneumonia, insomnia, musculoskeletal pain, arthralgia, arthritis. Spiriva dosage: N/A.
Multiple prescriptions taken:
  • Advair Diskus (1 Anz)
  • Advair Diskus (2 Anz)
  • Sierrasil Joint Formula
  • Altace


Cardiac Arrest
on Mar 13, 2014 Male from US , 58 years of age, was diagnosed with and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: cardiac arrest. Spiriva dosage: 18 Mcg.
Multiple concurrent drugs taken:
  • Advair
  • Proventil
  • Albuterol
  • Diovan
  • Pletal


Deep Vein Thrombosis, Myocardial Infarction, Depression, Sleep Apnoea Syndrome, Abnormal Loss Of Weight
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: deep vein thrombosis, myocardial infarction, depression, sleep apnoea syndrome, abnormal loss of weight on Mar 10, 2014 from US Additional patient health information: Male , 44 years of age, weighting 152.1 lb, was diagnosed with and. Spiriva dosage: 18 Mcg.

Renal Tumour Excision, Cerebrovascular Accident, Dyspnoea, Pericardial Effusion, Local Swelling
Adverse event was reported on Mar 10, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , weighting 127.9 lb, Patient felt the following Spiriva side effects: renal tumour excision, cerebrovascular accident, dyspnoea, pericardial effusion, local swelling.
Multiple prescriptions taken:
  • Pradaxa
Patient was hospitalized.

Diverticulitis, Pancreatic Cyst, Abdominal Pain, Urinary Tract Infection
on Mar 27, 2014 Female from US , 61 years of age, weighting 138.9 lb, was diagnosed with and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: diverticulitis, pancreatic cyst, abdominal pain, urinary tract infection. Spiriva dosage: 18 Mcg.
Multiple concurrent drugs taken:
  • Cefdinir (600 Mg)
Patient was hospitalized.

Dyspnoea, Renal Failure, Urinary Tract Infection
on Mar 10, 2014 Female from US , 77 years of age, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dyspnoea, renal failure, urinary tract infection. Spiriva dosage: 18 Mcg. Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Spiriva Side Effects

    Did You Have a Spiriva Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Spiriva for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative SPIRIVA Names:TIOTROPIU

    Active Ingredient: TIOTROPIU

    Spiriva Dosage, Warnings, Usage.

    Side Effects reported to FDA: 9515

    Spiriva safety alerts: 2008

    Reported deaths: 735

    Reported hospitalizations: 2882

    Spiriva (tiotropium bromide inhalation powder) Capsules

    Foradil (formoterol fumarate inhalation powder) Capsules

    Audience: Pulmonologists, respiratory therapists, pharmacists, other healthcare professionals, patients

    [Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the American Association of Poison Control CenterÔ??s (AAPCC) National Poison Data System have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products.

    [February 29, 2008 - Public Health Advisory - FDA]

    Latest Spiriva clinical trials