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Spiriva Side Effects

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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.

Spiriva Side Effects Reported to FDA



Spiriva Side Effect Report#9999628
Visual Acuity Reduced, Amnesia, Weight Decreased
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Spiriva (dosage: 18 Mcg, start time: 2013), combined with:
  • Advair Diskus (Fomulation: Inhalation Spray; Strength: 500/50 Mcg; Daily Dose: 1000/100 Mcg)
and developed a serious reaction and side effect(s): Visual Acuity Reduced, Amnesia, Weight Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in male patients, resulting in Visual Acuity Reduced side effect.
Spiriva Side Effect Report#9999598
Dry Eye, Thirst, Abnormal Faeces, Abnormal Faeces, Faeces Hard, Constipation, Dry Mouth, Lip Dry, Off Label Use
This report suggests a potential Spiriva Dry Eye side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthma and used Spiriva (dosage: 18 Mcg) starting 201311. After starting Spiriva the patient began experiencing various side effects, including: Dry Eye, Thirst, Abnormal Faeces, Abnormal Faeces, Faeces Hard, Constipation, Dry Mouth, Lip Dry, Off Label UseAdditional drugs used concurrently:
  • Advair Diskus (Formulation: Inhalation Spray, Strength: 500/50 Mcg; Daily Dose: 1000/100 Mcg)
  • Montelukast (10 Mg)
  • Guaifenesin (800 Mg)
  • Fluticasone (50 Mcg)
Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dry Eye, may still occur.
Spiriva Side Effect Report#9999525
Dry Skin, Pallor, Rash Erythematous
This Dry Skin problem was reported by a pharmacist from CA. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Spiriva (dosage: 1 Anz). The following drugs were being taken at the same time:
  • Advair
  • Perindopril
  • Ranitidine
  • Salbutamol
When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Dry Skin, Pallor, Rash ErythematousAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dry Skin, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9999460
Infectious Pleural Effusion, Lung Abscess, Pneumonia
This Infectious Pleural Effusion side effect was reported by a physician from CA. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spiriva (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Advair
  • Enbrel (7.1429 Mg)
  • Methotrexate (2.8571 Mg)
  • Salbutamol
  • Prednisone (40 Mg)
.After starting to take Spiriva the consumer reported adverse symptoms, such as: Infectious Pleural Effusion, Lung Abscess, PneumoniaThese side effects may potentially be related to Spiriva. The patient was hospitalized.
Spiriva Side Effect Report#9998009
Hip Fracture
This is a report of a 71-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Spiriva (dosage: 18 Mcg, start time: NS), combined with:
  • Metformin
  • Pletal
  • Plavix
  • Hydrochlorothiazide
  • Tricor
  • Wellbutrin
  • Gabapentin
  • Simvastatin
and developed a serious reaction and side effect(s): Hip Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in female patients, resulting in Hip Fracture side effect. The patient was hospitalized.
Spiriva Side Effect Report#9997916
Myocardial Infarction, Dizziness
This report suggests a potential Spiriva Myocardial Infarction side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Spiriva (dosage: 18 Mcg) starting 201207. After starting Spiriva the patient began experiencing various side effects, including: Myocardial Infarction, DizzinessAdditional drugs used concurrently: NA.The patient was hospitalized. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Spiriva Side Effect Report#9997808
Lumbar Vertebral Fracture, Upper Respiratory Tract Infection
This Lumbar Vertebral Fracture problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease,back pain. On 2007 this consumer started treatment with Spiriva (dosage: 18 Mcg). The following drugs were being taken at the same time:
  • Norco
  • Oxycontin (20 Mg)
  • Dulera ((inhalation Aerosol))
When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Lumbar Vertebral Fracture, Upper Respiratory Tract InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lumbar Vertebral Fracture, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9997627
Muscle Spasms, Muscle Spasms
This Muscle Spasms side effect was reported by a consumer or non-health professional from US. A 76-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease.The patient was prescribed Spiriva (drug dosage: 18 Mcg), which was initiated on 201310. Concurrently used drugs:
  • Symbicort (4 Puf)
  • Norvasc (10 Mg)
  • Losartin (100 Mg)
  • Metaprolol Er (100 Mg)
.After starting to take Spiriva the consumer reported adverse symptoms, such as: Muscle Spasms, Muscle SpasmsThese side effects may potentially be related to Spiriva.
Spiriva Side Effect Report#9996239
Paraesthesia, Dry Mouth, Off Label Use
This is a report of a 83-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: asthma, who was treated with Spiriva (dosage: 18 Mcg, start time:
Feb 26, 2014), combined with: NA. and developed a serious reaction and side effect(s): Paraesthesia, Dry Mouth, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in female patients, resulting in Paraesthesia side effect.
Spiriva Side Effect Report#9996070
Off Label Use
This report suggests a potential Spiriva Off Label Use side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cardiac failure congestive and used Spiriva (dosage: 18 Mcg) starting 2013. After starting Spiriva the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently: NA. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Spiriva Side Effect Report#9996063
Off Label Use
This Off Label Use problem was reported by a consumer or non-health professional from US. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: asthma. On 201310 this consumer started treatment with Spiriva (dosage: 18 Mcg). The following drugs were being taken at the same time: NA. When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Off Label Use, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9996062
Off Label Use
This Off Label Use side effect was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: cough.The patient was prescribed Spiriva (drug dosage: 18 Mcg), which was initiated on
Feb 17, 2014. Concurrently used drugs: NA..After starting to take Spiriva the consumer reported adverse symptoms, such as: Off Label UseThese side effects may potentially be related to Spiriva.
Spiriva Side Effect Report#9995914
Arthritis, Bone Disorder, Candida Infection, Chest Pain, Choking, Condition Aggravated, Decreased Appetite, Dyspnoea, Fear Of Eating
This is a report of a 66-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Spiriva (dosage: NA, start time: NS), combined with:
  • Advair Diskus
  • Advair Diskus (Dose Per Application Unit: Dosage Forms)
  • Advair Diskus
  • Advair Diskus
  • Ventolin (Dose Per Application Unit: Dosage Forms)
  • Morphine
and developed a serious reaction and side effect(s): Arthritis, Bone Disorder, Candida Infection, Chest Pain, Choking, Condition Aggravated, Decreased Appetite, Dyspnoea, Fear Of Eating after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in female patients, resulting in Arthritis side effect.
Spiriva Side Effect Report#9995905
Anxiety
This report suggests a potential Spiriva Anxiety side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Spiriva (dosage: 18 Mcg) starting 2012. After starting Spiriva the patient began experiencing various side effects, including: AnxietyAdditional drugs used concurrently: NA. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Spiriva Side Effect Report#9995903
Malaise, Product Quality Issue
This Malaise problem was reported by a pharmacist from US. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease. On NS this consumer started treatment with Spiriva (dosage: 18 Mcg). The following drugs were being taken at the same time: NA. When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Malaise, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9995486
Vision Blurred, Off Label Use
This Vision Blurred side effect was reported by a consumer or non-health professional from US. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumonia.The patient was prescribed Spiriva (drug dosage: 18 Mcg), which was initiated on 201302. Concurrently used drugs: NA..After starting to take Spiriva the consumer reported adverse symptoms, such as: Vision Blurred, Off Label UseThese side effects may potentially be related to Spiriva.
Spiriva Side Effect Report#9994750
Dry Eye, Thirst, Dry Mouth, Abdominal Distension, Infrequent Bowel Movements, Dysuria, Abnormal Faeces, Proctalgia, Intestinal Obstruction
This is a report of a 49-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: asthma, who was treated with Spiriva (dosage: 2 Puffs, start time:
Nov 20, 2013), combined with:
  • Sluticasone Propionate
  • Montelukast Sod
  • Guaiifenesin
and developed a serious reaction and side effect(s): Dry Eye, Thirst, Dry Mouth, Abdominal Distension, Infrequent Bowel Movements, Dysuria, Abnormal Faeces, Proctalgia, Intestinal Obstruction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in male patients, resulting in Dry Eye side effect.
Spiriva Side Effect Report#9993698
Prescribed Overdose, Off Label Use
This report suggests a potential Spiriva Prescribed Overdose side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthma and used Spiriva (dosage: 36 Mcg) starting
Feb 01, 2014. After starting Spiriva the patient began experiencing various side effects, including: Prescribed Overdose, Off Label UseAdditional drugs used concurrently: NA. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prescribed Overdose, may still occur.
Spiriva Side Effect Report#9993648
Arthritis, Chronic Obstructive Pulmonary Disease
This Arthritis problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease. On 2011 this consumer started treatment with Spiriva (dosage: 18 Mcg). The following drugs were being taken at the same time:
  • Synmbicort (Formulation: Inhalation Aerosol)
  • Neurotin
  • Vesicare
  • Albuterol (Formulation: Inhalation Aerosol)
  • Allopurinol
When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Arthritis, Chronic Obstructive Pulmonary DiseaseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthritis, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9993638
Condition Aggravated, Dyspnoea, Musculoskeletal Stiffness, Neck Pain, Pneumonia, Insomnia, Musculoskeletal Pain, Arthralgia, Arthritis
This Condition Aggravated side effect was reported by a consumer or non-health professional from CA. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spiriva (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Advair Diskus (1 Anz)
  • Advair Diskus (2 Anz)
  • Sierrasil Joint Formula
  • Altace
.After starting to take Spiriva the consumer reported adverse symptoms, such as: Condition Aggravated, Dyspnoea, Musculoskeletal Stiffness, Neck Pain, Pneumonia, Insomnia, Musculoskeletal Pain, Arthralgia, ArthritisThese side effects may potentially be related to Spiriva.
Spiriva Side Effect Report#9993246
Cardiac Arrest
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Spiriva (dosage: 18 Mcg, start time: 2004), combined with:
  • Advair
  • Proventil
  • Albuterol
  • Diovan
  • Pletal
and developed a serious reaction and side effect(s): Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in male patients, resulting in Cardiac Arrest side effect.
Spiriva Side Effect Report#9992816
Deep Vein Thrombosis, Myocardial Infarction, Myocardial Infarction, Depression, Sleep Apnoea Syndrome, Abnormal Loss Of Weight
This report suggests a potential Spiriva Deep Vein Thrombosis side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Spiriva (dosage: 18 Mcg) starting NS. After starting Spiriva the patient began experiencing various side effects, including: Deep Vein Thrombosis, Myocardial Infarction, Myocardial Infarction, Depression, Sleep Apnoea Syndrome, Abnormal Loss Of WeightAdditional drugs used concurrently: NA. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Spiriva Side Effect Report#9992792
Renal Tumour Excision, Cerebrovascular Accident, Dyspnoea, Pericardial Effusion, Local Swelling
This Renal Tumour Excision problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: dyspnoea. On 2012 this consumer started treatment with Spiriva (dosage: 18 Mcg). The following drugs were being taken at the same time:
  • Pradaxa
When using Spiriva, the patient experienced the following unwanted symptoms/side effects: Renal Tumour Excision, Cerebrovascular Accident, Dyspnoea, Pericardial Effusion, Local SwellingThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Tumour Excision, may become evident only after a product is in use by the general population.
Spiriva Side Effect Report#9992622
Diverticulitis, Pancreatic Cyst, Abdominal Pain, Urinary Tract Infection
This Diverticulitis side effect was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease,urinary tract infection.The patient was prescribed Spiriva (drug dosage: 18 Mcg), which was initiated on 201210. Concurrently used drugs:
  • Cefdinir (600 Mg)
.After starting to take Spiriva the consumer reported adverse symptoms, such as: Diverticulitis, Pancreatic Cyst, Abdominal Pain, Urinary Tract InfectionThese side effects may potentially be related to Spiriva. The patient was hospitalized.
Spiriva Side Effect Report#9992588
Dyspnoea, Renal Failure, Urinary Tract Infection
This is a report of a 77-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Spiriva (dosage: 18 Mcg, start time: 2008), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea, Renal Failure, Urinary Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spiriva treatment in female patients, resulting in Dyspnoea side effect. The patient was hospitalized.


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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.


What are common Spiriva Side Effects for Women?

Women Side EffectsReports
Dyspnoea 1424
Product Quality Issue 1193
Dry Mouth 389
Cough 379
Pneumonia 282
Dysphonia 241
Off Label Use 235
Chronic Obstructive Pulmonary Disease 186
Dizziness 172
Vision Blurred 167

What are common Spiriva Side Effects for Men?

Men Side EffectsReports
Dyspnoea 781
Product Quality Issue 458
Dry Mouth 222
Pneumonia 213
Chronic Obstructive Pulmonary Disease 188
Cough 152
Off Label Use 129
Death 97
Constipation 95
Dysuria 90

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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    How Effective is Spiriva for You?

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    Spiriva Safety Alerts, Active Ingredients, Usage Information

    NDC0597-0075
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSpiriva
    NameTIOTROPIUM BROMIDE
    Dosage FormCAPSULE
    RouteORAL; RESPIRATORY (INHALATION)
    On market since20051011
    LabelerBoehringer Ingelheim Pharmaceuticals Inc.
    Active Ingredient(s)TIOTROPIUM BROMIDE MONOHYDRATE
    Strength(s)18
    Unit(s)ug/1
    Pharma ClassAnticholinergic [EPC],Cholinergic Antagonists [MoA]

    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]

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