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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
This is a report of a male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Visual Acuity Reduced
  • Amnesia
  • Weight Decreased
which developed 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.

Dry Eye, Thirst, Abnormal Faeces, Faeces Hard, Constipation, Dry Mouth, Lip Dry, Off Label Use
This report suggests a potential Spiriva Dry Eye, Thirst, Abnormal Faeces, Faeces Hard, Constipation, Dry Mouth, Lip Dry, Off Label Use 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. Soon after starting Spiriva the patient began experiencing various side effects, including:
  • Dry Eye
  • Thirst
  • Abnormal Faeces
  • Faeces Hard
  • Constipation
  • Dry Mouth
  • Lip Dry
  • Off Label Use
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.

Dry Skin, Pallor, Rash Erythematous
This Dry Skin, Pallor, Rash Erythematous 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 commencing Spiriva, the patient experienced the following unwanted symptoms/side effects:
  • Dry Skin
  • Pallor
  • Rash Erythematous
Although 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.

Infectious Pleural Effusion, Lung Abscess, Pneumonia
This is a report of a 64-year-old male patient (weight: NA) from CA. The patient developed the following symptoms/conditions: NA and was treated with Spiriva (dosage: NA) starting NS. Concurrently used drugs:
  • Advair
  • Enbrel (7.1429 Mg)
  • Methotrexate (2.8571 Mg)
  • Salbutamol
  • Prednisone (40 Mg)
Soon after that, the consumer experienced the following side effects:
  • Infectious Pleural Effusion
  • Lung Abscess
  • Pneumonia
The patient was hospitalized. This opens a possibility that Spiriva treatment could cause the above reactions, including infectious pleural effusion, and some male subjects may be more susceptible.


Hip Fracture
A 71-year-old female patient (weight: NA) from US with the following symptoms/conditions: chronic obstructive pulmonary disease started Spiriva treatment (dosage: 18 Mcg) on NS. Soon after starting Spiriva treatment, the subject experienced various side effects, including:
  • Hip Fracture
Concurrently used drugs:
  • Metformin
  • Pletal
  • Plavix
  • Hydrochlorothiazide
  • Tricor
  • Wellbutrin
  • Gabapentin
  • Simvastatin
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Spiriva.

Myocardial Infarction, Dizziness
A 65-year-old female patient from US (weight: NA) experienced symptoms, such as: chronic obstructive pulmonary disease and was treated with Spiriva(dosage: 18 Mcg). The treatment was initiated on 201207. After that a consumer reported the following side effect(s):
  • Myocardial Infarction
  • Dizziness
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Spiriva efficacy: NA.The patient was hospitalized.

Lumbar Vertebral Fracture, Upper Respiratory Tract Infection
In this report, Spiriva was administered for the following condition: chronic obstructive pulmonary disease,back pain.A female consumer from US (weight: NA) started Spiriva treatment (dosage: 18 Mcg) on 2007.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Lumbar Vertebral Fracture
  • Upper Respiratory Tract Infection
A possible interaction with other drugs could have contributed to this reaction:
  • Norco
  • Oxycontin (20 Mg)
  • Dulera ((inhalation Aerosol))
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Spiriva treatment could be related to the listed above side effect(s).

Muscle Spasms
This is a report of the following Spiriva side effect(s):
  • Muscle Spasms
A 76-year-old female patient from US (weight: NA) presented with the following condition: chronic obstructive pulmonary disease and received a treatment with Spiriva (dosage: 18 Mcg) starting: 201310.The following concurrently used drugs could have generated interactions:
  • Symbicort (4 Puf)
  • Norvasc (10 Mg)
  • Losartin (100 Mg)
  • Metaprolol Er (100 Mg)
This report suggests that a Spiriva treatment could be associated with the listed above side effect(s).

Paraesthesia, Dry Mouth, Off Label Use
This Spiriva report was submitted by a 83-year-old female consumer from US (weight: NA). The patient was diagnosed with: asthma and Spiriva was administered (dosage: 18 Mcg) starting: Feb 26, 2014. The consumer developed a set of symptoms:
  • Paraesthesia
  • Dry Mouth
  • Off Label Use
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Spiriva treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Off Label Use
This is a report of a possible correlation between Spiriva use and the following symptoms/side effect(s):
  • Off Label Use
which could contribute to an assessment of Spiriva risk profile.A 75-year-old male consumer from US (weight: NA) was suffering from cardiac failure congestive and was treated with Spiriva (dosage: 18 Mcg) starting 2013.Other concurrent medications: NA.

Off Label Use
A 34-year-old female patient from US (weight: NA) presented with the following symptoms: asthma and after a treatment with Spiriva (dosage: 18 Mcg) experienced the following side effect(s):
  • Off Label Use
The treatment was started on 201310. Spiriva was used in combination with the following drugs: NA.This report could alert potential Spiriva consumers.

Off Label Use
In this report, a 48-year-old female patient from US (weight: NA) was affected by a possible Spiriva side effect.The patient was diagnosed with cough. After a treatment with Spiriva (dosage: 18 Mcg, start date: Feb 17, 2014), the patient experienced the following side effect(s):
  • Off Label Use
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Spiriva treatment.

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 from CA (weight: NA), who used Spiriva (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Arthritis
  • Bone Disorder
  • Candida Infection
  • Chest Pain
  • Choking
  • Condition Aggravated
  • Decreased Appetite
  • Dyspnoea
  • Fear Of Eating
The following drugs could possibly have interacted with the Spiriva treatment
  • Advair Diskus
  • Advair Diskus (Dose Per Application Unit: Dosage Forms)
  • Advair Diskus
  • Advair Diskus
  • Ventolin (Dose Per Application Unit: Dosage Forms)
  • Morphine
Taken together, these observations suggest that a Spiriva treatment could be related to side effect(s), such as Arthritis, Bone Disorder, Candida Infection, Chest Pain, Choking, Condition Aggravated, Decreased Appetite, Dyspnoea, Fear Of Eating.

Anxiety
This anxiety side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease. The patient was prescribed Spiriva (dosage: 18 Mcg), which was started on 2012. Concurrently used drugs: NA. When starting to take Spiriva the consumer reported the following symptoms:
  • Anxiety
These side effects may potentially be related to Spiriva.

Malaise, Product Quality Issue
This is a Spiriva side effect report of a 75-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Spiriva (dosage:18 Mcg, start time: NS), combined with: NA., and developed a serious reaction and a malaise side effect. The patient presented with:
  • Malaise
  • Product Quality Issue
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Spiriva treatment in female patients suffering from chronic obstructive pulmonary disease, resulting in malaise.

Vision Blurred, Off Label Use
This report suggests a potential Spiriva vision blurred side effect(s) that can have serious consequences. A 63-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): pneumonia and used Spiriva (dosage: 18 Mcg) starting 201302. Soon after starting Spiriva the patient began experiencing various side effects, including:
  • Vision Blurred
  • Off Label Use
Drugs used concurrently:NA. Although Spiriva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as vision blurred, may still occur.

Dry Eye, Thirst, Dry Mouth, Abdominal Distension, Infrequent Bowel Movements, Dysuria, Abnormal Faeces, Proctalgia, Intestinal Obstruction
This dry eye problem was reported by a health professional from US. A 49-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): asthma.On Nov 20, 2013 a consumer started treatment with Spiriva (dosage: 2 Puffs). The following drugs/medications were being taken at the same time:
  • Sluticasone Propionate
  • Montelukast Sod
  • Guaiifenesin
When commencing Spiriva, the patient experienced the following unwanted symptoms /side effects:
  • Dry Eye
  • Thirst
  • Dry Mouth
  • Abdominal Distension
  • Infrequent Bowel Movements
  • Dysuria
  • Abnormal Faeces
  • Proctalgia
  • Intestinal Obstruction
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as dry eye, may become evident only after a product is in use by the general population.

Prescribed Overdose, Off Label Use
This is a Spiriva side effect report of a 61-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: asthma and was treated with Spiriva (dosage: 36 Mcg) starting Feb 01, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Prescribed Overdose
  • Off Label Use
This opens a possibility that Spiriva could cause prescribed overdose and that some male patients may be more susceptible.

Arthritis, Chronic Obstructive Pulmonary Disease
A female patient (weight: NA) from US with the following symptoms: chronic obstructive pulmonary disease started Spiriva treatment (dosage: 18 Mcg) on 2011. Soon after starting Spiriva treatment, the consumer experienced several side effects, including:
  • Arthritis
  • Chronic Obstructive Pulmonary Disease
. Concurrently used drugs:
  • Synmbicort (Formulation: Inhalation Aerosol)
  • Neurotin
  • Vesicare
  • Albuterol (Formulation: Inhalation Aerosol)
  • Allopurinol
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Spiriva side effects, such as arthritis.

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 (dosage: NA), which was started on NS. Concurrently used drugs:
  • Advair Diskus (1 Anz)
  • Advair Diskus (2 Anz)
  • Sierrasil Joint Formula
  • Altace
.When starting to take Spiriva the consumer reported symptoms, such as:
  • Condition Aggravated
  • Dyspnoea
  • Musculoskeletal Stiffness
  • Neck Pain
  • Pneumonia
  • Insomnia
  • Musculoskeletal Pain
  • Arthralgia
  • Arthritis
These side effects may potentially be related to Spiriva.

Cardiac Arrest
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Cardiac Arrest
which developed 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.

Deep Vein Thrombosis, Myocardial Infarction, Depression, Sleep Apnoea Syndrome, Abnormal Loss Of Weight
This report suggests a potential Spiriva Deep Vein Thrombosis, Myocardial Infarction, Depression, Sleep Apnoea Syndrome, Abnormal Loss Of Weight 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. Soon after starting Spiriva the patient began experiencing various side effects, including:
  • Deep Vein Thrombosis
  • Myocardial Infarction
  • Depression
  • Sleep Apnoea Syndrome
  • Abnormal Loss Of Weight
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.

Renal Tumour Excision, Cerebrovascular Accident, Dyspnoea, Pericardial Effusion, Local Swelling
This Renal Tumour Excision, Cerebrovascular Accident, Dyspnoea, Pericardial Effusion, Local Swelling 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 commencing Spiriva, the patient experienced the following unwanted symptoms/side effects:
  • Renal Tumour Excision
  • Cerebrovascular Accident
  • Dyspnoea
  • Pericardial Effusion
  • Local Swelling
The 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.

Diverticulitis, Pancreatic Cyst, Abdominal Pain, Urinary Tract Infection
This is a report of a 61-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: chronic obstructive pulmonary disease,urinary tract infection and was treated with Spiriva (dosage: 18 Mcg) starting 201210. Concurrently used drugs:
  • Cefdinir (600 Mg)
Soon after that, the consumer experienced the following side effects:
  • Diverticulitis
  • Pancreatic Cyst
  • Abdominal Pain
  • Urinary Tract Infection
The patient was hospitalized. This opens a possibility that Spiriva treatment could cause the above reactions, including diverticulitis, and some female subjects may be more susceptible.

Dyspnoea, Renal Failure, Urinary Tract Infection
A 77-year-old female patient (weight: NA) from US with the following symptoms/conditions: chronic obstructive pulmonary disease started Spiriva treatment (dosage: 18 Mcg) on 2008. Soon after starting Spiriva treatment, the subject experienced various side effects, including:
  • Dyspnoea
  • Renal Failure
  • Urinary Tract Infection
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Spiriva.

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Top 10 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

Top 10 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

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

    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

    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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