CALENDULA OFFICINALIS

N/A

Manufactured by Seroyal USA

56 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CALENDULA OFFICINALIS

CALENDULA OFFICINALIS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Seroyal USA. The most commonly reported adverse reactions for CALENDULA OFFICINALIS include DRUG INEFFECTIVE, ERYTHEMA, FEBRILE NEUTROPENIA, ABDOMINAL PAIN, ACUTE VESTIBULAR SYNDROME. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CALENDULA OFFICINALIS.

Top Adverse Reactions

DRUG INEFFECTIVE2 reports
ERYTHEMA2 reports
FEBRILE NEUTROPENIA2 reports
ABDOMINAL PAIN1 reports
ACUTE VESTIBULAR SYNDROME1 reports
APPLICATION SITE BURN1 reports
ASTHENIA1 reports
BACK PAIN1 reports
BLOOD TESTOSTERONE INCREASED1 reports
BRADYPHRENIA1 reports
BURNS FIRST DEGREE1 reports
CEREBRAL DISORDER1 reports
CHEST PAIN1 reports
CORONARY ARTERY OCCLUSION1 reports
DECREASED APPETITE1 reports
DEHYDRATION1 reports
DEPRESSION1 reports
DIARRHOEA1 reports
DRUG INTERACTION1 reports
DYSPHAGIA1 reports
FEAR1 reports
GASTROINTESTINAL DISORDER1 reports
HAEMATURIA1 reports
HAEMOGLOBIN DECREASED1 reports
ILLNESS1 reports
IMPAIRED WORK ABILITY1 reports
INCORRECT PRODUCT ADMINISTRATION DURATION1 reports
LETHARGY1 reports
MALIGNANT NEOPLASM PROGRESSION1 reports
MUSCULOSKELETAL STIFFNESS1 reports
MYALGIA1 reports
NEUTROPENIA1 reports
NEUTROPENIC SEPSIS1 reports
OFF LABEL USE1 reports
PAIN1 reports
PAIN IN EXTREMITY1 reports
PRODUCT USE IN UNAPPROVED INDICATION1 reports
PROSTATIC SPECIFIC ANTIGEN INCREASED1 reports
PRURITUS1 reports
PYREXIA1 reports
SCAB1 reports
SKIN DISCOLOURATION1 reports
SKIN EXFOLIATION1 reports
SKIN LESION1 reports
SKIN TIGHTNESS1 reports
SKIN ULCER1 reports
SOMNOLENCE1 reports
SUICIDAL IDEATION1 reports
THERAPEUTIC RESPONSE DECREASED1 reports
URINARY RETENTION1 reports
WEIGHT DECREASED1 reports
WEIGHT INCREASED1 reports
WHITE BLOOD CELL COUNT DECREASED1 reports

Report Outcomes

Out of 10 classified reports for CALENDULA OFFICINALIS:

Serious 60.0%Non-Serious 40.0%

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 (55.6%)
Male4 (44.4%)

Reports by Age

Age 602 reports
Age 581 reports
Age 591 reports
Age 631 reports
Age 761 reports
Age 871 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 CALENDULA OFFICINALIS?

This profile reflects 56 FDA FAERS reports that mention CALENDULA OFFICINALIS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CALENDULA OFFICINALIS?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, ERYTHEMA, FEBRILE NEUTROPENIA, ABDOMINAL PAIN, ACUTE VESTIBULAR SYNDROME, APPLICATION SITE BURN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CALENDULA OFFICINALIS?

Labeling and FAERS entries often list Seroyal USA in connection with CALENDULA OFFICINALIS. 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.