TIOTROPIUM BROMIDE INHALATION SPRAY

N/A

Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

25,050 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TIOTROPIUM BROMIDE INHALATION SPRAY

TIOTROPIUM BROMIDE INHALATION SPRAY 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 TIOTROPIUM BROMIDE INHALATION SPRAY include DYSPNOEA, ASTHMA, COUGH, WHEEZING, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIOTROPIUM BROMIDE INHALATION SPRAY.

Top Adverse Reactions

DYSPNOEA2,171 reports
ASTHMA1,421 reports
COUGH1,009 reports
WHEEZING818 reports
PNEUMONIA777 reports
DRUG INEFFECTIVE714 reports
OFF LABEL USE653 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE580 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE545 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES520 reports
FATIGUE461 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION438 reports
HEADACHE406 reports
DEATH379 reports
MALAISE370 reports
FALL357 reports
PRODUCT QUALITY ISSUE347 reports
PRODUCT DOSE OMISSION ISSUE337 reports
CHEST DISCOMFORT336 reports
DIZZINESS330 reports
COVID 19328 reports
PRODUCTIVE COUGH315 reports
NAUSEA293 reports
PAIN286 reports
ASTHENIA271 reports
DIARRHOEA244 reports
NASOPHARYNGITIS243 reports
SINUSITIS231 reports
PYREXIA227 reports
OBSTRUCTIVE AIRWAYS DISORDER222 reports
INFLUENZA221 reports
WEIGHT DECREASED219 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION215 reports
DYSPNOEA EXERTIONAL214 reports
OROPHARYNGEAL PAIN209 reports
BRONCHITIS205 reports
BLOOD COUNT ABNORMAL195 reports
RASH192 reports
VOMITING192 reports
CONDITION AGGRAVATED189 reports
PRURITUS186 reports
ARTHRALGIA185 reports
ILLNESS185 reports
CHEST PAIN184 reports
URINARY TRACT INFECTION177 reports
NASAL CONGESTION175 reports
ANXIETY164 reports
BACK PAIN162 reports
INFECTION160 reports
FEELING ABNORMAL156 reports
PRODUCT USE IN UNAPPROVED INDICATION154 reports
GASTROOESOPHAGEAL REFLUX DISEASE152 reports
DYSPHONIA147 reports
HYPERTENSION145 reports
PAIN IN EXTREMITY145 reports
FULL BLOOD COUNT ABNORMAL144 reports
INSOMNIA144 reports
OXYGEN SATURATION DECREASED144 reports
HOSPITALISATION138 reports
PRODUCT USE ISSUE135 reports
LOWER RESPIRATORY TRACT INFECTION133 reports
UPPER RESPIRATORY TRACT INFECTION133 reports
LUNG DISORDER130 reports
RHINORRHOEA129 reports
PERIPHERAL SWELLING128 reports
BLOOD PRESSURE INCREASED125 reports
DRY MOUTH124 reports
WEIGHT INCREASED124 reports
LUNG NEOPLASM MALIGNANT121 reports
ATRIAL FIBRILLATION119 reports
ABDOMINAL PAIN116 reports
VISION BLURRED114 reports
CEREBROVASCULAR ACCIDENT110 reports
HYPOTENSION110 reports
THROAT IRRITATION109 reports
SPUTUM DISCOLOURED107 reports
INTENTIONAL PRODUCT USE ISSUE106 reports
HYPERSENSITIVITY105 reports
ABDOMINAL PAIN UPPER103 reports
RESPIRATORY TRACT INFECTION103 reports
EOSINOPHIL COUNT INCREASED101 reports
HEART RATE INCREASED101 reports
INJECTION SITE PAIN100 reports
CONSTIPATION98 reports
DEVICE MALFUNCTION98 reports
TREMOR98 reports
GAIT DISTURBANCE97 reports
DECREASED APPETITE94 reports
DEPRESSION94 reports
EXTRA DOSE ADMINISTERED94 reports
MYOCARDIAL INFARCTION94 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS91 reports
CARDIAC DISORDER90 reports
URTICARIA88 reports
CATARACT86 reports
DEVICE ISSUE86 reports
RESPIRATORY FAILURE83 reports
SOMNOLENCE83 reports
MIGRAINE82 reports
ANAEMIA81 reports

Report Outcomes

Out of 10,369 classified reports for TIOTROPIUM BROMIDE INHALATION SPRAY:

Serious 59.6%Non-Serious 40.4%

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

Female5,942 (62.5%)
Male3,556 (37.4%)
Unknown2 (0.0%)

Reports by Age

Age 70210 reports
Age 71194 reports
Age 64187 reports
Age 73187 reports
Age 76186 reports
Age 68180 reports
Age 72170 reports
Age 74170 reports
Age 75167 reports
Age 67163 reports
Age 59155 reports
Age 66155 reports
Age 77151 reports
Age 69148 reports
Age 80147 reports
Age 61144 reports
Age 63141 reports
Age 65140 reports
Age 83131 reports
Age 78128 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 TIOTROPIUM BROMIDE INHALATION SPRAY?

This profile reflects 25,050 FDA FAERS reports that mention TIOTROPIUM BROMIDE INHALATION SPRAY. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TIOTROPIUM BROMIDE INHALATION SPRAY?

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

Who manufactures TIOTROPIUM BROMIDE INHALATION SPRAY?

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

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.