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Spiriva Side Effects

Report Spiriva Side Effects

If you experienced any harmful or unwanted effects of Spiriva, please share your experience. This could help to raise awareness about Spiriva side effects, identify uknown risks and inform health professionals and patients taking Spiriva.

Examples: headache, dizziness


The most commonly reported Spiriva side effects are:
Fatigue (93 reports)
Anxiety (61 reports)
Leg Cramps (59 reports)
Cough (56 reports)
Hair Loss (53 reports)
Weight Gain (36 reports)
Fatigue And Anxiety (34 reports)
Dry Mouth (17 reports)
Crusty Rash On Back Of Legs (12 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Spiriva side effects . You can also compare Spiriva side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Cardiac Failure Congestive, Blood Potassium Decreased, Blood Magnesium Decreased, Off Label Use
on Mar 10, 2014 Female from US , 62 years of age, weighting 264.6 lb, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: cardiac failure congestive, blood potassium decreased, blood magnesium decreased, off label use. Spiriva dosage: 18 Mcg.
Associated medications used:
  • Simvastatin (40 Mg)
  • Furosemide (80 Mg)
  • Fluoxetine (20 Mg)
  • Metoprolol (50 Mg)
  • Feso4 (325 Mg)
  • Calcitrol (0.25 Mcg)
  • Omeprazole (80 Mg)
  • Folic Acid (1 Mg)
Patient was hospitalized.

Dyspnoea, Product Quality Issue
Patient was taking Spiriva. Patient felt the following Spiriva side effects: dyspnoea, product quality issue on Mar 10, 2014 from US Additional patient health information: Male , 53 years of age, weighting 136.7 lb, was diagnosed with and. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:

Pyrexia, Respiratory Tract Infection, Productive Cough, Pain, Chills, Dyspnoea, Body Temperature Increased
Adverse event was reported on Mar 20, 2014 by a Male taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , 69 years of age, weighting 200.4 lb, After Spiriva was administered, patient encountered several Spiriva side effects: pyrexia, respiratory tract infection, productive cough, pain, chills, dyspnoea, body temperature increased.
Multiple concurrent drugs taken:
  • Advair (Strength: 100/50 Mg; Daily Dose: 200/100 Mg)
  • Albuterol
  • Aspirin (81 Mg)
  • Aspirin
  • Coreg (6.25 Mg)
  • Coreg
  • Crestor (10 Mg)
  • Lisnopril (20 Mg)


Pneumonia, Influenza
on Mar 17, 2014 Male from US , 68 years of age, was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: pneumonia, influenza. Spiriva dosage: 18 Mcg. Patient was hospitalized.


Blood Urine Present
on Mar 10, 2014 Female from CA , 80 years of age, was treated with Spiriva. Patient felt the following Spiriva side effects: blood urine present. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:

Fall, Hip Fracture, Orthopaedic Procedure, Pain, Walking Aid User, Weight Decreased, Hypersensitivity, Pruritus, Urticaria
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: fall, hip fracture, orthopaedic procedure, pain, walking aid user, weight decreased, hypersensitivity, pruritus, urticaria on Mar 07, 2014 from CA Additional patient health information: Male , 70 years of age, weighting 160.9 lb, . Spiriva dosage: N/A.
Multiple concurrent drugs taken:
  • Humira (2.8571 Mg)
  • Fiorinal
  • Furosemide
  • Ipratropium
  • Iron
  • Metoprolol - 25
  • Ramipril (Route: Opthalmic)
  • Salbutamol
Patient was hospitalized.

Pneumonia, Cataract, Headache, Influenza, Dysphagia
Adverse event was reported on Mar 07, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , weighting 138.9 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: pneumonia, cataract, headache, influenza, dysphagia.
Associated medications used:
  • Allegra
  • Symbicort
  • Proair
  • Lisinopril
  • Cephalexin
Patient was hospitalized.

Dizziness, Somnolence
on Mar 07, 2014 Male from US , 71 years of age, was treated with Spiriva. Patient felt the following Spiriva side effects: dizziness, somnolence. Spiriva dosage: 18 Mcg.

Off Label Use
on Mar 07, 2014 Male from US , 67 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.

Off Label Use
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: off label use on Mar 06, 2014 from US Additional patient health information: Male , 55 years of age, was diagnosed with and. Spiriva dosage: 18 Mcg.

Chronic Obstructive Pulmonary Disease, Alcoholism
Adverse event was reported on Mar 27, 2014 by a Male taking Spiriva (Dosage: 18 Mcg) . Location: US , 57 years of age, Patient felt the following Spiriva side effects: chronic obstructive pulmonary disease, alcoholism.
Multiple prescriptions taken:

Myocardial Infarction
on Mar 21, 2014 Male from US , 52 years of age, was diagnosed with and was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: myocardial infarction. Spiriva dosage: 18 Mcg.

Dysgeusia, Vomiting
on Mar 28, 2014 Male from US , 83 years of age, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dysgeusia, vomiting. Spiriva dosage: 18 Mcg.
Associated medications used:

Pneumonia, Blood Pressure Increased, Blood Glucose Increased, Dysphonia
Patient was taking Spiriva. Patient felt the following Spiriva side effects: pneumonia, blood pressure increased, blood glucose increased, dysphonia on Mar 06, 2014 from US Additional patient health information: Male , 75 years of age, weighting 198.4 lb, was diagnosed with and. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken: Patient was hospitalized.

Dyspnoea, Lung Infection, Nasopharyngitis, Cough, Increased Upper Airway Secretion, Tooth Disorder, Fall, Avulsion Fracture, Foot Fracture
Adverse event was reported on Mar 06, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , 63 years of age, weighting 191.8 lb, After Spiriva was administered, patient encountered several Spiriva side effects: dyspnoea, lung infection, nasopharyngitis, cough, increased upper airway secretion, tooth disorder, fall, avulsion fracture, foot fracture.
Multiple concurrent drugs taken:
  • Advair (Formulation: Inhalation Aerosol)
  • Albuterol (Formulation: Inhalation Solution)
  • Enbrel (50 Mg)
  • Proair (Formulation: Inhalation Solution)
  • Norvasc (10 Mg)
  • Losartin
  • Hctz (25 Mg)
  • K Dur (Dose Per Application And Daily Dose: 10 Meg)
Patient was hospitalized.

Dyspnoea
on Mar 06, 2014 Female from US , 97 years of age, weighting 154.3 lb, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dyspnoea. Spiriva dosage: 18 Mcg.
Associated medications used:
  • Advair (Formulation: Inhalation Spray)
Patient was hospitalized.

Heart Rate Decreased, Blood Pressure Decreased, Atrial Fibrillation
on Mar 06, 2014 Female from US , 73 years of age, weighting 136.7 lb, was diagnosed with and was treated with Spiriva. Patient felt the following Spiriva side effects: heart rate decreased, blood pressure decreased, atrial fibrillation. Spiriva dosage: 18 Mcg.
Multiple prescriptions taken:
  • Verapamil 24 Hour Er (240 Mg)
  • Omeprazole (20 Mg)
  • Omeprazole
  • Levothyroxine (Alternating 75 Microgram And 50 Microgram Every Other Day.)
  • Zetia (10 Mg)
  • Aspirin (325 Mg)
Patient was hospitalized.

Epistaxis, Tremor
Patient was taking Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: epistaxis, tremor on Mar 06, 2014 from US Additional patient health information: Female , 71 years of age, was diagnosed with and. Spiriva dosage: 18 Mcg.
Multiple concurrent drugs taken:

Dry Mouth, Aphonia, Oropharyngeal Pain, Increased Upper Airway Secretion, Off Label Use
Adverse event was reported on Mar 06, 2014 by a Female taking Spiriva (Dosage: 18 Mcg) was diagnosed with
  • asthma
  • hypertension
  • hypothyroidism
and. Location: US , 83 years of age, weighting 149.9 lb, Directly after, patient experienced the unwanted or unexpected Spiriva side effects: dry mouth, aphonia, oropharyngeal pain, increased upper airway secretion, off label use.
Associated medications used:
  • Toprol (25 Mg)
  • Levothyroxine (1 Mcg)


Hypotension
on Mar 06, 2014 Female from US , 61 years of age, weighting 167.6 lb, was diagnosed with and was treated with Spiriva. Patient felt the following Spiriva side effects: hypotension. Spiriva dosage: 18 Mcg.

Off Label Use
on Mar 06, 2014 Female from US , 76 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.

Off Label Use
Patient was taking Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: off label use on Mar 06, 2014 from US Additional patient health information: Male , 78 years of age, was diagnosed with and. Spiriva dosage: 18 Mcg.

Convulsion, Cerebral Haemorrhage, Fall, Dyspnoea, Oropharyngeal Pain, Product Quality Issue
Adverse event was reported on Mar 26, 2014 by a Male taking Spiriva (Dosage: 18 Mcg) was diagnosed with and. Location: US , 57 years of age, weighting 160.9 lb, Patient felt the following Spiriva side effects: convulsion, cerebral haemorrhage, fall, dyspnoea, oropharyngeal pain, product quality issue.
Multiple prescriptions taken:
  • Lasix
  • Aldactone
  • Advair (Formulation: Inhalation Spray)
  • Erythromycin
  • Prandin
  • Kombiglyze
Patient was hospitalized.

Coronary Artery Occlusion
on Mar 05, 2014 Male from US , 80 years of age, was treated with Spiriva. After Spiriva was administered, patient encountered several Spiriva side effects: coronary artery occlusion. Spiriva dosage: 18 Mcg. Patient was hospitalized.

Myocardial Infarction, Chronic Sinusitis, Hypertension
on Mar 27, 2014 Male from US , 64 years of age, was diagnosed with and was treated with Spiriva. Directly after, patient experienced the unwanted or unexpected Spiriva side effects: myocardial infarction, chronic sinusitis, hypertension. Spiriva dosage: 18 Mcg.
Associated medications used: Patient was hospitalized.

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Record and Track Your Side Effects

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.

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JustAnswer.com

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