ROFLUMILAST

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

15,466 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ROFLUMILAST

ROFLUMILAST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for ROFLUMILAST include DYSPNOEA, DEATH, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROFLUMILAST.

Top Adverse Reactions

DYSPNOEA1,011 reports
DEATH730 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE631 reports
DIARRHOEA568 reports
NAUSEA466 reports
PNEUMONIA450 reports
WEIGHT DECREASED436 reports
HEADACHE404 reports
OFF LABEL USE393 reports
DRUG INEFFECTIVE349 reports
COUGH346 reports
INSOMNIA313 reports
DIZZINESS300 reports
ASTHMA284 reports
DECREASED APPETITE282 reports
MALAISE282 reports
FATIGUE281 reports
BACK PAIN217 reports
WHEEZING217 reports
CONDITION AGGRAVATED197 reports
ANXIETY196 reports
ASTHENIA189 reports
TREMOR183 reports
PAIN156 reports
DEPRESSION155 reports
FALL148 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE148 reports
FEELING ABNORMAL139 reports
BRONCHITIS134 reports
VOMITING134 reports
PAIN IN EXTREMITY133 reports
PRODUCT DOSE OMISSION ISSUE131 reports
PRODUCTIVE COUGH130 reports
PRURITUS127 reports
NASOPHARYNGITIS124 reports
HYPERTENSION123 reports
ARTHRALGIA121 reports
RASH120 reports
DRUG DOSE OMISSION117 reports
CHEST PAIN110 reports
CHEST DISCOMFORT108 reports
HEART RATE INCREASED108 reports
INTENTIONAL PRODUCT MISUSE101 reports
OBSTRUCTIVE AIRWAYS DISORDER101 reports
SUICIDAL IDEATION100 reports
INFLUENZA99 reports
ABDOMINAL PAIN UPPER97 reports
FULL BLOOD COUNT ABNORMAL94 reports
BLOOD PRESSURE INCREASED90 reports
PRODUCT USE ISSUE90 reports
ABDOMINAL DISCOMFORT89 reports
LUNG DISORDER87 reports
EMPHYSEMA86 reports
HYPOTENSION86 reports
COVID 1985 reports
OXYGEN SATURATION DECREASED85 reports
PRODUCT QUALITY ISSUE85 reports
GASTROOESOPHAGEAL REFLUX DISEASE84 reports
WEIGHT INCREASED83 reports
MUSCLE SPASMS82 reports
PYREXIA82 reports
MEMORY IMPAIRMENT80 reports
ABDOMINAL PAIN79 reports
PRODUCT USE IN UNAPPROVED INDICATION79 reports
RESPIRATORY TRACT INFECTION79 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION78 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES78 reports
OEDEMA PERIPHERAL76 reports
SPUTUM DISCOLOURED75 reports
RESPIRATORY FAILURE74 reports
SINUSITIS74 reports
PALPITATIONS72 reports
RENAL FAILURE72 reports
INFLUENZA LIKE ILLNESS71 reports
URINARY TRACT INFECTION69 reports
CARDIAC FAILURE CONGESTIVE68 reports
UPPER RESPIRATORY TRACT INFECTION68 reports
ILLNESS67 reports
PULMONARY MASS67 reports
TACHYCARDIA66 reports
ATRIAL FIBRILLATION65 reports
DEHYDRATION65 reports
PERIPHERAL SWELLING65 reports
CONSTIPATION64 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION63 reports
SOMNOLENCE62 reports
DRUG HYPERSENSITIVITY61 reports
DYSPNOEA EXERTIONAL61 reports
ANAEMIA59 reports
MYOCARDIAL INFARCTION58 reports
CHRONIC KIDNEY DISEASE57 reports
CONFUSIONAL STATE57 reports
INFECTION57 reports
NASAL CONGESTION57 reports
VISION BLURRED57 reports
INCORRECT DOSE ADMINISTERED55 reports
DRUG INTERACTION54 reports
PSORIASIS54 reports
ERYTHEMA53 reports
HYPERSENSITIVITY53 reports

Report Outcomes

Out of 6,442 classified reports for ROFLUMILAST:

Serious 62.5%Non-Serious 37.5%

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

Female3,084 (53.9%)
Male2,626 (45.9%)
Unknown16 (0.3%)

Reports by Age

Age 69147 reports
Age 75147 reports
Age 70142 reports
Age 71136 reports
Age 74128 reports
Age 68127 reports
Age 67119 reports
Age 66118 reports
Age 77116 reports
Age 64111 reports
Age 73109 reports
Age 60107 reports
Age 72105 reports
Age 62102 reports
Age 61100 reports
Age 6598 reports
Age 7696 reports
Age 6383 reports
Age 8078 reports
Age 7876 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 ROFLUMILAST?

This profile reflects 15,466 FDA FAERS reports that mention ROFLUMILAST. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROFLUMILAST?

Frequently reported terms in FAERS include DYSPNOEA, DEATH, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIARRHOEA, NAUSEA, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROFLUMILAST?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with ROFLUMILAST. 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.