DORNASE ALFA

N/A

Manufactured by Genentech, Inc.

29,815 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DORNASE ALFA

DORNASE ALFA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for DORNASE ALFA include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, CYSTIC FIBROSIS, HOSPITALISATION, PNEUMONIA, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DORNASE ALFA.

Top Adverse Reactions

INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS2,282 reports
CYSTIC FIBROSIS1,727 reports
HOSPITALISATION1,289 reports
PNEUMONIA1,269 reports
COUGH980 reports
OFF LABEL USE934 reports
INFECTION922 reports
NO ADVERSE EVENT919 reports
DYSPNOEA898 reports
CONDITION AGGRAVATED601 reports
HEADACHE536 reports
PULMONARY FUNCTION TEST DECREASED484 reports
DEATH471 reports
MALAISE465 reports
HAEMOPTYSIS450 reports
PYREXIA449 reports
FATIGUE442 reports
INFLUENZA441 reports
NASOPHARYNGITIS375 reports
PRODUCTIVE COUGH373 reports
NAUSEA354 reports
DIARRHOEA348 reports
LUNG DISORDER324 reports
PSEUDOMONAS INFECTION322 reports
WEIGHT DECREASED317 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION308 reports
ABDOMINAL PAIN UPPER298 reports
CHEST DISCOMFORT298 reports
VOMITING293 reports
ANXIETY286 reports
LUNG INFECTION268 reports
PRODUCT STORAGE ERROR250 reports
RASH246 reports
SINUSITIS242 reports
WEIGHT INCREASED239 reports
WHEEZING232 reports
ABDOMINAL PAIN228 reports
DRUG INEFFECTIVE226 reports
CONSTIPATION225 reports
ASTHMA215 reports
PAIN209 reports
DEPRESSION208 reports
COVID 19199 reports
CHEST PAIN193 reports
DIZZINESS185 reports
PRODUCT DOSE OMISSION ISSUE184 reports
TREATMENT NONCOMPLIANCE180 reports
ILLNESS178 reports
DECREASED APPETITE176 reports
STAPHYLOCOCCAL INFECTION165 reports
VIRAL INFECTION164 reports
DRUG HYPERSENSITIVITY156 reports
INSOMNIA155 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES151 reports
UPPER RESPIRATORY TRACT INFECTION151 reports
ILL DEFINED DISORDER148 reports
GASTROINTESTINAL DISORDER143 reports
INTENTIONAL PRODUCT USE ISSUE138 reports
RESPIRATORY FAILURE137 reports
PRODUCT DOSE OMISSION135 reports
ALANINE AMINOTRANSFERASE INCREASED131 reports
ABDOMINAL DISCOMFORT129 reports
INTESTINAL OBSTRUCTION129 reports
DRUG DOSE OMISSION128 reports
DYSPHONIA128 reports
HEPATIC ENZYME INCREASED127 reports
PNEUMOTHORAX127 reports
MYALGIA126 reports
INTERCEPTED MEDICATION ERROR125 reports
LOWER RESPIRATORY TRACT INFECTION125 reports
OROPHARYNGEAL PAIN125 reports
BRONCHOSPASM123 reports
SPUTUM INCREASED122 reports
DEHYDRATION121 reports
FALL119 reports
LUNG TRANSPLANT118 reports
FEELING ABNORMAL117 reports
SINUS OPERATION117 reports
ASPARTATE AMINOTRANSFERASE INCREASED115 reports
INTERCEPTED PRODUCT STORAGE ERROR115 reports
ATELECTASIS114 reports
FORCED EXPIRATORY VOLUME DECREASED114 reports
OXYGEN SATURATION DECREASED114 reports
ASTHENIA113 reports
NEPHROLITHIASIS113 reports
PRODUCT USE IN UNAPPROVED INDICATION113 reports
SINUS DISORDER113 reports
RESPIRATORY DISORDER112 reports
BRONCHIAL SECRETION RETENTION110 reports
HEART RATE INCREASED110 reports
ARTHRALGIA108 reports
NASAL CONGESTION108 reports
HYPERSENSITIVITY106 reports
RHINORRHOEA106 reports
GENERAL PHYSICAL HEALTH DETERIORATION105 reports
SLEEP DISORDER104 reports
ABDOMINAL DISTENSION102 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE102 reports
DISEASE COMPLICATION100 reports
URTICARIA100 reports

Report Outcomes

Out of 19,170 classified reports for DORNASE ALFA:

Serious 68.5%Non-Serious 31.5%

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

Female9,905 (54.9%)
Male8,142 (45.1%)
Unknown6 (0.0%)

Reports by Age

Age 16442 reports
Age 17433 reports
Age 18407 reports
Age 15384 reports
Age 13378 reports
Age 12367 reports
Age 19365 reports
Age 14357 reports
Age 11345 reports
Age 20341 reports
Age 25330 reports
Age 22304 reports
Age 21300 reports
Age 23279 reports
Age 24278 reports
Age 10251 reports
Age 32240 reports
Age 9228 reports
Age 27228 reports
Age 30226 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 DORNASE ALFA?

This profile reflects 29,815 FDA FAERS reports that mention DORNASE ALFA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DORNASE ALFA?

Frequently reported terms in FAERS include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, CYSTIC FIBROSIS, HOSPITALISATION, PNEUMONIA, COUGH, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DORNASE ALFA?

Labeling and FAERS entries often list Genentech, Inc. in connection with DORNASE ALFA. 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.