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Spiriva (Tiotropium Inhalation) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Spiriva (Tiotropium Inhalation) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (4392)
Death (121)
Life Threatening Events (45)
Disability (36)

Reports by Reaction Type

Incorrect Route of Drug Administration (1887)Dyspnoea (640)Drug Ineffective (271)DRY Mouth (140)Pneumonia (131)Cough (119)Chronic Obstructive Pulmonary Disease (111)Bronchitis (79)Death (70)Chest Discomfort (68)Dysphonia (66)Vision Blurred (63)

Below are a few examples of reports where side effects / adverse reactions may be related to Spiriva (Tiotropium Inhalation). For a complete list or a specific selection of reports, please use the links above.

Possible Spiriva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Product Quality Issue, Dyspnoea

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Indomethacin; Lortab; Omeprazole; Fluticasone Propionate



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Abnormal Dreams, Arthralgia, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Celebrex
    Dosage: unk

Norvasc
    Dosage: unk

Spiriva
    Dosage: unk

Zoloft
    Dosage: unk



Possible Spiriva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Dyspnoea

Drug(s) suspected as cause:
Spiriva



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Cough

Drug(s) suspected as cause:
Spiriva



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Albuterol



Possible Spiriva side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 68 year old female

Reactions: Glossodynia, Dyspnoea, Drug Ineffective, Diplegia, Blood Potassium Increased, Sinus Operation, Chronic Obstructive Pulmonary Disease, Loss of Consciousness, Oral Candidiasis, Muscle Spasms, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivent
    Dosage: 2puff four times per day
    Indication: Emphysema
    Start date: 2000-01-01

Fluticasone Propionate
    Dosage: 1puff twice per day
    Indication: Product Used FOR Unknown Indication

Potassium
    Indication: Supplementation Therapy
    End date: 2011-01-01

Spiriva
    Dosage: 18mcg see dosage text
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2009-01-01

Other drugs received by patient: Cartia XT; Premarin; Tylenol; Promethazine; Tramadol HCL; Aspirin; Calcium Carbonate; Fish OIL; Furosemide; Protonix; Norco; Spironolactone; Diovan; Multi-Vitamin; Vitamin B-12; Calcium; Coumadin; Betamethasone + Clotrimazole; Metoprolol; Provera; Oxygen; Pravastatin



Possible Spiriva side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 64.4 kg (141.7 pounds)

Reactions: Carotid Artery Stenosis, Blindness Unilateral

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Fluticasone Propionate; Aspirin; Medication NOT Further Specified



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: DRY Mouth, Leukoplakia Oral

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Fluticasone Propionate; Lortab; Soma; MS Contin; Cymbalta



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Dyspnoea, Headache, Bronchitis, Cough

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Lutein; Calcium D3; Metoprolol Tartrate; Calcium; Metoprolol Tartrate; Vitamin D; Lutein; Aspirin; ONE-A-DAY Vitamin; Foradil; Foradil; Magnesium; Levothyroxine Sodium; Multi-Vitamin



Possible Spiriva side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Migraine, Nerve Injury, Pain in Extremity

Drug(s) suspected as cause:
Aldactone

Lyrica

Spiriva



Possible Spiriva side effects in 64 year old female

Reported by a pharmacist from Canada on 2012-08-27

Patient: 64 year old female

Reactions: Product Quality Issue, Dyspnoea, Drug Ineffective, Adrenal Neoplasm

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Ventolin; Fluticasone Propionate



Possible Spiriva side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 66.7 kg (146.7 pounds)

Reactions: Throat Irritation, Rhinorrhoea, Oropharyngeal Pain, Cough

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Fluticasone Propionate; Metoprolol Tartrate; Aspirin



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Oral Pain, Leukoplakia Oral

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Thyroid TAB; Acyclovir; Pravastatin; Vicodin; Aspirin; Celebrex; Ranitidine



Possible Spiriva side effects in 90 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 90 year old female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Advair Diskus 100 / 50; Albuterol



Possible Spiriva side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Fatigue, Dysphonia, DRY Mouth, Oropharyngeal Pain, Constipation

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Aspirin; Pravastatin; Xanax; Ranexa; Cardizem; Isosorbide; Nitroglycerin



Possible Spiriva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Dyspnoea

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Aspirin; Proventil; Finasteride; Fish OIL; Palmetto; Albuterol; Theophylline; Doxazosin Mesylate



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Sleep Disorder, DRY Mouth

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Feldene; Levothyroxine Sodium; Hydrocodone



Possible Spiriva side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Malaise

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Symbicort; Trazodone Hydrochloride; Ventolin; Digoxin; Furosemide; Levothyroxine Sodium; Klopeon; Detrol LA; Citalopram Hydrobromide



Possible Spiriva side effects in 72 year old male

Reported by a physician from United States on 2012-08-26

Patient: 72 year old male

Reactions: Haemoptysis, Dehydration, Lung Neoplasm, Cough

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Plavix; Aspirin



Possible Spiriva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: male

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-01-01

Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20



Possible Spiriva side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: male

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-01



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva

Spiriva
    Administration route: Oral
    Start date: 2012-08-19
    End date: 2012-08-19



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease

Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Dyspnoea

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Accolate; Symbicort



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Dosage: 18 mcg
    Indication: Bronchitis Chronic
    Start date: 2012-07-20

Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20

Other drugs received by patient: Claritin; Xanax; Lortab; Potassium; Coq10; Celexa; Amlodipine; Fish OIL



Possible Spiriva side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-04-30



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20

Spiriva
    Dosage: 18 mcg
    Indication: Dyspnoea
    Start date: 2012-08-01



Possible Spiriva side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: 78 year old female

Reactions: Pruritus, Pigmentation Disorder, Rash

Drug(s) suspected as cause:
Spiriva



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Spiriva
    Administration route: Oral
    Start date: 2012-08-20
    End date: 2012-08-20

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-01



Possible Spiriva side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient: female

Reactions: Sneezing

Drug(s) suspected as cause:
Spiriva

Other drugs received by patient: Detrol LA; Hydrocodone Bitartrate; Meloxicam; Plavix; Singulair; Ranitidine; Flovent; Lasix; Medroxyprogesterone; Albuterol Sulfate; Soma; Flexeril; Prednisone TAB; Clotrimazole and Betamethasone Dipropionate

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