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Fatigue (92)
Anxiety (60)
Leg Cramps (59)
Cough (54)
Hair Loss (52)
Fatigue And Anxiety (34)
Weight Gain (34)
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Spiriva Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 5679 

Red Blood Cell Count Decreased, White Blood Cell Count Decreased, Pneumonia (8442590-8)
on Jun 27, 2011 Male from UNITED STATES , 67 years of age, was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: red blood cell count decreased, white blood cell count decreased, pneumonia. Spiriva dosage: N/A.
Associated medications used:
  • Symbicort (symbicort Turbuhaler ^draco:)
  • Ativan
  • Lantus
  • Bactrim Ds
  • Creon
  • Revlimid (10 Mg, X 21 Days, Po)
  • Atenolol
  • Prandin (prepaglinide)
Patient was hospitalized.

Pneumonia, Pulmonary Fibrosis, Pulmonary Function Test Abnormal, Oral Fungal Infection, Upper Respiratory Fungal Infection (8441690-6)
Patient was taking Spiriva. Patient felt the following Spiriva side effects: pneumonia, pulmonary fibrosis, pulmonary function test abnormal, oral fungal infection, upper respiratory fungal infection on Jun 11, 2012 from GERMANY Additional patient health information: Male , weighting 187.4 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Simvahexal 40mg
  • Obsidan 40mg
  • Pantoprazol Tad 40mg
  • Methizol Sd 5mg
  • Irenat Tropfen
  • Korodin Herz Kreisl. Tr.
  • Kinzalkomb 80/12.5
  • Prednisolon 10mg Jena


Hip Fracture, Total Lung Capacity Decreased (8439686-3)
Adverse event was reported on Jun 12, 2012 by a Female taking Spiriva (Dosage: Unk) was diagnosed with
  • chronic obstructive pulmonary disease
and. Location: UNITED STATES , 93 years of age, After Spiriva was administered, patient encountered several Spiriva side effects: hip fracture, total lung capacity decreased.
Multiple concurrent drugs taken:
  • Lipitor (Unk)


Oesophageal Candidiasis (8436995-9)
on Jun 10, 2012 Female from UNITED STATES , 73 years of age, weighting 140.0 lb, was diagnosed with
  • chronic obstructive pulmonary disease
  • seasonal allergy
and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: oesophageal candidiasis. Spiriva dosage: 1 Capsule Daily Inhal.


Ageusia (8435368-2)
on Jun 04, 2012 Female from UNITED STATES , 70 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Spiriva. Patient felt the following Spiriva side effects: ageusia. Spiriva dosage: 18 Mcg.

Dehydration, White Blood Cell Count Decreased (8434794-5)
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: dehydration, white blood cell count decreased on May 31, 2011 from UNITED STATES Additional patient health information: Female , 64 years of age, . Spiriva dosage: N/A.
Multiple concurrent drugs taken:
  • Advair Hfa
  • Revlimid (15 Mg, 1 In 1 D, Po)
  • Boniva
  • Synthroid
Patient was hospitalized.

Neuropathy Peripheral, Headache (8433229-6)
Adverse event was reported on Dec 15, 2011 by a Male taking Spiriva (Dosage: N/A) . Location: UNITED STATES , 60 years of age, weighting 245.0 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: neuropathy peripheral, headache.
Associated medications used:
  • Lyrica
  • Zometa
  • Revlimid (25 Mg, Days 1 Through 21 Every 28 Days, Po 10 Mg, Days 1 Through 21 Every 28 Days, Po)
  • Revlimid (25 Mg, Days 1 Through 21 Every 28 Days, Po 10 Mg, Days 1 Through 21 Every 28 Days, Po)
  • Norco


Chest Discomfort, Nasal Discomfort, Throat Irritation (8432694-8)
on Jun 05, 2012 Female from UNITED STATES , weighting 135.0 lb, was diagnosed with
  • chronic obstructive pulmonary disease
  • headache
  • blood cholesterol increased
  • pain
and was treated with Spiriva. Patient felt the following Spiriva side effects: chest discomfort, nasal discomfort, throat irritation. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Excedrin (migraine)
  • Pravastatin (10 Mg)
  • Excedrin (migraine)
  • Benzonatate
  • Xopenex


Coordination Abnormal (8432690-0)
on Jun 05, 2012 Male from UNITED STATES , weighting 277.0 lb, was diagnosed with
  • dyspnoea
and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: coordination abnormal. Spiriva dosage: N/A.
Multiple concurrent drugs taken:
  • Labetalol Hydrochloride
  • Symbicort


Hip Fracture, Total Lung Capacity Decreased (8430906-8)
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: hip fracture, total lung capacity decreased on Jun 07, 2012 from UNITED STATES Additional patient health information: Female , 93 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Spiriva dosage: Unk.
Associated medications used:
  • Lipitor (Unk)


Dyspnoea, Chest Discomfort (8428573-2)
Adverse event was reported on May 31, 2012 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with
  • bronchitis chronic
and. Location: UNITED STATES , 67 years of age, Patient felt the following Spiriva side effects: dyspnoea, chest discomfort.
Multiple prescriptions taken:
  • Advair Diskus 100/50


Cardiac Failure Congestive (8426729-6)
on May 18, 2011 Male from UNITED STATES , 86 years of age, weighting 257.9 lb, was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: cardiac failure congestive. Spiriva dosage: N/A.
Multiple concurrent drugs taken:
  • Revlimid (5 Mg, 1 In 1 D, Po)
  • Lasix (flurosemide)
  • Glipizide
  • Advair Hfa
Patient was hospitalized.

Dyspnoea, Blister (8425891-9)
on May 30, 2012 Female from UNITED STATES , 53 years of age, was diagnosed with
  • emphysema
and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dyspnoea, blister. Spiriva dosage: 18 Mcg.
Associated medications used:
  • Proventil
  • Advair Diskus 100/50
  • Combivent (10 Puf)
  • Xanax
  • Albuterol


Inappropriate Antidiuretic Hormone Secretion, Respiratory Failure, Intentional Overdose, Hyponatraemia, Miosis, Somnolence (8424446-X)
Patient was taking Spiriva. Patient felt the following Spiriva side effects: inappropriate antidiuretic hormone secretion, respiratory failure, intentional overdose, hyponatraemia, miosis, somnolence on May 28, 2012 from UNITED KINGDOM Additional patient health information: Male , 56 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Spiriva dosage: N/A.
Multiple prescriptions taken:
  • Co-dydramol (20x10mg Dihydrocodeine/20x500mg Paracetamol)
  • Tramadol Hcl (60x50mg)
  • Fluticasone Propionate/salmeterol
Patient was hospitalized.

Dyspnoea, Disease Progression, Nasal Congestion (8424233-2)
Adverse event was reported on Oct 19, 2011 by a Male taking Spiriva (Dosage: N/A) . Location: UNITED STATES , 72 years of age, weighting 158.1 lb, After Spiriva was administered, patient encountered several Spiriva side effects: dyspnoea, disease progression, nasal congestion.
Multiple concurrent drugs taken:
  • Pulmicort
  • Xopenex
  • Pulmicort
  • Brovana


Chronic Obstructive Pulmonary Disease (8423831-X)
on May 24, 2011 Female from UNITED STATES , 74 years of age, was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: chronic obstructive pulmonary disease. Spiriva dosage: N/A.
Associated medications used:
  • Atacand


Fall, Tremor, Headache, Diarrhoea, Decreased Appetite, Nausea, Dizziness, Pneumonia, Renal Failure Acute (8423588-2)
on Jun 05, 2012 Female from UNITED STATES , weighting 180.0 lb, was treated with Spiriva. Patient felt the following Spiriva side effects: fall, tremor, headache, diarrhoea, decreased appetite, nausea, dizziness, pneumonia, renal failure acute. Spiriva dosage: N/A.
Multiple prescriptions taken:
  • Phenazopyridine Hcl Tab (200 Mg As Needed)
  • Oxygen (5l At Bedtime)
  • Advair Diskus 100/50 (500/50)
  • Prilosec (20 Mg)
  • Halcion (0.25 Mg At Bedtime)
  • Fosamax (One Time Per Week)
  • Nystatin
  • Daliresp (500 Mcg)
Patient was hospitalized.

Constipation, Eye Pain, Skin Irritation, Increased Upper Airway Secretion (8419220-4)
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: constipation, eye pain, skin irritation, increased upper airway secretion on May 30, 2012 from UNITED STATES Additional patient health information: Female , 91 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Spiriva dosage: 18 Mcg.

Tendon Rupture, Thrombosis (8417091-3)
Adverse event was reported on May 30, 2012 by a Male taking Spiriva (Dosage: N/A) was diagnosed with
  • lung disorder
  • pneumonia
and. Location: UNITED STATES , weighting 200.0 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: tendon rupture, thrombosis.
Associated medications used:
  • Levofloxacin
  • Combivent
  • Prednisone Tab (Every Other Day)
  • Toprol-xl
  • Glyburide
  • Theophylline
  • Toprol-xl
  • Januvia


Chronic Obstructive Pulmonary Disease, Colitis, Pneumonia (8416668-9)
on Mar 22, 2011 Male from UNITED STATES , 86 years of age, weighting 257.9 lb, was treated with Spiriva. Patient felt the following Spiriva side effects: chronic obstructive pulmonary disease, colitis, pneumonia. Spiriva dosage: N/A.
Multiple prescriptions taken:
  • Revlimid (5 Mg, 1 In 1 D, Po)
  • Lasix
  • Advair Hfa
  • Glipizide
Patient was hospitalized.

Suicidal Ideation, Agitation (8416177-7)
on Jun 01, 2012 Male from GREECE , 70 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: suicidal ideation, agitation. Spiriva dosage: 1 Df Every Morning.
Multiple concurrent drugs taken:
  • Lexotanil (1 Df, 1-2 Times Per Year)
  • Onbrez
  • Asmanex Twisthaler (1 Df Every Morning)


Feeling Abnormal, Somnolence, Dizziness, Hot Flush, Headache (8415200-3)
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: feeling abnormal, somnolence, dizziness, hot flush, headache on Jun 01, 2012 from UNITED STATES Additional patient health information: Female , weighting 130.0 lb, was diagnosed with
  • emphysema
and. Spiriva dosage: Unk, Daily In The Morning.
Associated medications used:
  • Combivent (Unk, Every 4 Hrs)
  • Prednisone Tab (50 Mg, Unk)
  • Advair Diskus 100/50 (Unk, 2x/day)
  • Prednisone Tab (40 Mg, Unk)
  • Revatio (20 Mg, 3x/day)
  • Prednisone Tab (Unk)


Metastatic Neoplasm (8408711-8)
Adverse event was reported on May 30, 2012 by a Male taking Spiriva (Dosage: 5 Mcg) . Location: JAPAN , 79 years of age, Patient felt the following Spiriva side effects: metastatic neoplasm.
Multiple prescriptions taken:
  • Tirashizin (50 Mcg)
  • Erythromycin (300 Mg)
  • Gasmotin (15 Mg)
Patient was hospitalized.

Adverse Event, Brain Stem Stroke, Abdominal Discomfort, Muscle Spasms, Muscle Fatigue, Memory Impairment, Hypersensitivity, Headache (8407988-2)
on May 31, 2012 Female from UNITED STATES , 50 years of age, weighting 240.3 lb, was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: adverse event, brain stem stroke, abdominal discomfort, muscle spasms, muscle fatigue, memory impairment, hypersensitivity, headache. Spiriva dosage: N/A.
Multiple concurrent drugs taken:
  • Loperamide Hydrochloride
  • Zanaflex
  • Lorazepam
  • Garlic Oil
  • Cyclocort
  • Benadryl
  • Zocor
  • Lipitor


Dry Eye, Eye Pain, Dry Mouth, Burning Sensation, Skin Exfoliation (8405744-2)
on May 30, 2012 Female from UNITED STATES , 76 years of age, weighting 130.0 lb, was diagnosed with
  • chronic obstructive pulmonary disease
  • dry eye
and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dry eye, eye pain, dry mouth, burning sensation, skin exfoliation. Spiriva dosage: 1 Capsule Once A Day Inhaler.
Associated medications used:
  • Restasis (1 Drop Twice A Day Both Eyes)


Showing 1-25 of 5679 

Spiriva Health Episodes

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Spiriva Information

Alternative SPIRIVA Names:TIOTROPIU

Active Ingredient: TIOTROPIU

Spiriva Dosage, Warnings, Usage.

Side Effects reported to FDA: 5679. View Spiriva Adverse Reports

Spiriva safety alerts: 2008

Reported deaths: 401

Reported hospitalizations: 1340

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]

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