Spiriva

N/A

Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

266,551 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Spiriva

Spiriva is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. The most commonly reported adverse reactions for Spiriva include INCORRECT ROUTE OF DRUG ADMINISTRATION, DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Spiriva.

Top Adverse Reactions

INCORRECT ROUTE OF DRUG ADMINISTRATION23,308 reports
DYSPNOEA20,984 reports
ASTHMA9,662 reports
DRUG INEFFECTIVE9,031 reports
COUGH8,053 reports
PNEUMONIA7,976 reports
WHEEZING6,001 reports
PRODUCT QUALITY ISSUE5,895 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE5,790 reports
FATIGUE5,060 reports
OFF LABEL USE4,482 reports
MALAISE4,281 reports
NAUSEA3,789 reports
HEADACHE3,686 reports
DEATH3,643 reports
FALL3,571 reports
DIZZINESS3,377 reports
PRODUCTIVE COUGH3,344 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE3,220 reports
PAIN3,178 reports
DIARRHOEA3,094 reports
ASTHENIA3,093 reports
CHEST DISCOMFORT2,947 reports
WEIGHT DECREASED2,906 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES2,677 reports
NASOPHARYNGITIS2,573 reports
BRONCHITIS2,474 reports
DRY MOUTH2,468 reports
OBSTRUCTIVE AIRWAYS DISORDER2,431 reports
VOMITING2,413 reports
PYREXIA2,329 reports
DYSPHONIA2,284 reports
ARTHRALGIA2,230 reports
CHEST PAIN2,195 reports
CONDITION AGGRAVATED2,191 reports
ANXIETY2,159 reports
CONSTIPATION2,132 reports
PAIN IN EXTREMITY2,120 reports
RASH2,103 reports
HYPERTENSION2,039 reports
DYSPNOEA EXERTIONAL2,038 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION2,023 reports
WEIGHT INCREASED1,986 reports
PRURITUS1,984 reports
BACK PAIN1,867 reports
INSOMNIA1,798 reports
BLOOD PRESSURE INCREASED1,767 reports
INFLUENZA1,678 reports
OROPHARYNGEAL PAIN1,643 reports
HYPOTENSION1,625 reports
SINUSITIS1,625 reports
FEELING ABNORMAL1,592 reports
OEDEMA PERIPHERAL1,575 reports
OXYGEN SATURATION DECREASED1,561 reports
VISION BLURRED1,547 reports
HEART RATE INCREASED1,519 reports
LUNG DISORDER1,506 reports
DECREASED APPETITE1,466 reports
DEPRESSION1,458 reports
GASTROOESOPHAGEAL REFLUX DISEASE1,448 reports
MYOCARDIAL INFARCTION1,391 reports
TREMOR1,387 reports
URINARY TRACT INFECTION1,380 reports
GAIT DISTURBANCE1,370 reports
FULL BLOOD COUNT ABNORMAL1,359 reports
NASAL CONGESTION1,331 reports
ANAEMIA1,330 reports
ATRIAL FIBRILLATION1,326 reports
HYPERSENSITIVITY1,265 reports
ABDOMINAL PAIN1,259 reports
SPUTUM DISCOLOURED1,254 reports
CARDIAC FAILURE CONGESTIVE1,244 reports
OVERDOSE1,239 reports
MUSCLE SPASMS1,221 reports
PERIPHERAL SWELLING1,220 reports
LUNG NEOPLASM MALIGNANT1,212 reports
BLOOD COUNT ABNORMAL1,172 reports
CATARACT1,151 reports
LOWER RESPIRATORY TRACT INFECTION1,144 reports
PRODUCT DOSE OMISSION ISSUE1,134 reports
ABDOMINAL PAIN UPPER1,133 reports
ACUTE KIDNEY INJURY1,128 reports
CEREBROVASCULAR ACCIDENT1,107 reports
RENAL FAILURE1,100 reports
INFECTION1,088 reports
RESPIRATORY FAILURE1,082 reports
RHINORRHOEA1,058 reports
URTICARIA1,053 reports
DRUG HYPERSENSITIVITY1,048 reports
INCORRECT DOSE ADMINISTERED1,007 reports
UPPER RESPIRATORY TRACT INFECTION996 reports
SOMNOLENCE987 reports
HAEMOPTYSIS962 reports
DRUG DOSE OMISSION949 reports
GENERAL PHYSICAL HEALTH DETERIORATION944 reports
BALANCE DISORDER934 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION927 reports
CONTUSION923 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION923 reports
MYALGIA918 reports

Report Outcomes

Out of 128,267 classified reports for Spiriva:

  • Serious: 61,728 reports (48.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 66,539 reports (51.9%)
Serious 48.1%Non-Serious 51.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female73,116 (60.6%)
Male47,014 (39.0%)
Unknown436 (0.4%)

Reports by Age

Age 722,505 reports
Age 702,481 reports
Age 772,473 reports
Age 712,406 reports
Age 732,376 reports
Age 742,355 reports
Age 682,352 reports
Age 692,343 reports
Age 752,323 reports
Age 662,281 reports
Age 652,165 reports
Age 672,163 reports
Age 762,058 reports
Age 642,054 reports
Age 631,984 reports
Age 621,863 reports
Age 781,851 reports
Age 801,838 reports
Age 611,815 reports
Age 601,726 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Spiriva?

This profile reflects 266,551 FDA FAERS reports that mention Spiriva. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Spiriva?

Frequently reported terms in FAERS include INCORRECT ROUTE OF DRUG ADMINISTRATION, DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, COUGH, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Spiriva?

Labeling and FAERS entries often list Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Spiriva. Always verify the specific product and NDC with your pharmacist.

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Drugs Also Linked to INCORRECT ROUTE OF DRUG ADMINISTRATION

The following drugs share commonly reported adverse reactions with Spiriva:

NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE (65/100)TIOTROPIUM BROMIDE (72/100)

View all drugs reporting INCORRECT ROUTE OF DRUG ADMINISTRATION →

Explore More

Safety RankingsSearch All DrugsCompare DrugsBoehringer Ingelheim Pharmaceuticals, Inc. PortfolioINCORRECT ROUTE OF DRUG ADMINISTRATION in Other DrugsDYSPNOEA in Other DrugsASTHMA in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.