ARNICA MONTANA

N/A

Manufactured by Laboratoires Boiron

789 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ARNICA MONTANA

ARNICA MONTANA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Laboratoires Boiron. The most commonly reported adverse reactions for ARNICA MONTANA include FATIGUE, PAIN, HEADACHE, ARTHRALGIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ARNICA MONTANA.

Top Adverse Reactions

FATIGUE27 reports
PAIN26 reports
HEADACHE25 reports
ARTHRALGIA23 reports
DIARRHOEA19 reports
NAUSEA18 reports
BACK PAIN15 reports
ASTHENIA14 reports
DIZZINESS14 reports
DRUG INEFFECTIVE14 reports
DYSPNOEA14 reports
PAIN IN EXTREMITY14 reports
DRUG HYPERSENSITIVITY13 reports
INSOMNIA13 reports
VISION BLURRED13 reports
FALL12 reports
PALPITATIONS12 reports
CONTUSION11 reports
HYPERSENSITIVITY11 reports
MALAISE11 reports
MUSCULAR WEAKNESS11 reports
OFF LABEL USE11 reports
PRURITUS11 reports
DRY MOUTH10 reports
ERYTHEMA10 reports
MYALGIA10 reports
SOMNOLENCE10 reports
BALANCE DISORDER9 reports
BLOOD PRESSURE INCREASED9 reports
GAIT DISTURBANCE9 reports
PARAESTHESIA9 reports
ANXIETY8 reports
COUGH8 reports
HOT FLUSH8 reports
PERIPHERAL SWELLING8 reports
RASH8 reports
ABDOMINAL DISTENSION7 reports
ABDOMINAL PAIN UPPER7 reports
FLATULENCE7 reports
HYPERHIDROSIS7 reports
HYPOAESTHESIA7 reports
JOINT SWELLING7 reports
MUSCLE SPASMS7 reports
BLISTER6 reports
CARDIAC DISORDER6 reports
CHEST PAIN6 reports
CONFUSIONAL STATE6 reports
CONSTIPATION6 reports
DYSPHONIA6 reports
FEELING ABNORMAL6 reports
FOOT DEFORMITY6 reports
HAND DEFORMITY6 reports
INFECTION6 reports
INJECTION SITE PAIN6 reports
LUNG NEOPLASM MALIGNANT6 reports
PYREXIA6 reports
SKIN DISCOLOURATION6 reports
TREMOR6 reports
URINARY TRACT INFECTION6 reports
URTICARIA6 reports
ABDOMINAL PAIN5 reports
BURNING SENSATION5 reports
CHILLS5 reports
DERMATITIS ALLERGIC5 reports
DRY EYE5 reports
HEART RATE INCREASED5 reports
IRRITABLE BOWEL SYNDROME5 reports
LIMB INJURY5 reports
MUSCULOSKELETAL STIFFNESS5 reports
NASOPHARYNGITIS5 reports
WEIGHT DECREASED5 reports
WEIGHT INCREASED5 reports
ALOPECIA4 reports
BEDRIDDEN4 reports
BLOOD PRESSURE SYSTOLIC INCREASED4 reports
BONE PAIN4 reports
CEREBROVASCULAR ACCIDENT4 reports
DEATH4 reports
DISEASE PROGRESSION4 reports
DYSPEPSIA4 reports
EYE PAIN4 reports
GASTROOESOPHAGEAL REFLUX DISEASE4 reports
HEAD INJURY4 reports
HEPATOCELLULAR INJURY4 reports
HYPERKALAEMIA4 reports
INJECTION SITE ERYTHEMA4 reports
INJECTION SITE SWELLING4 reports
LOSS OF CONSCIOUSNESS4 reports
MIGRAINE4 reports
NEUROPATHY PERIPHERAL4 reports
OSTEOPOROSIS4 reports
RIB FRACTURE4 reports
ROAD TRAFFIC ACCIDENT4 reports
THERAPEUTIC PRODUCT EFFECT DECREASED4 reports
THIRST4 reports
THROMBOCYTOPENIA4 reports
TOE AMPUTATION4 reports
WHITE BLOOD CELL COUNT DECREASED4 reports
ABDOMINAL DISCOMFORT3 reports
ANAEMIA3 reports

Report Outcomes

Out of 271 classified reports for ARNICA MONTANA:

Serious 66.8%Non-Serious 33.2%

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

Female208 (82.2%)
Male43 (17.0%)
Unknown2 (0.8%)

Reports by Age

Age 8014 reports
Age 7312 reports
Age 648 reports
Age 777 reports
Age 576 reports
Age 606 reports
Age 656 reports
Age 716 reports
Age 445 reports
Age 485 reports
Age 725 reports
Age 785 reports
Age 464 reports
Age 474 reports
Age 504 reports
Age 614 reports
Age 664 reports
Age 704 reports
Age 513 reports
Age 533 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 ARNICA MONTANA?

This profile reflects 789 FDA FAERS reports that mention ARNICA MONTANA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ARNICA MONTANA?

Frequently reported terms in FAERS include FATIGUE, PAIN, HEADACHE, ARTHRALGIA, DIARRHOEA, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ARNICA MONTANA?

Labeling and FAERS entries often list Laboratoires Boiron in connection with ARNICA MONTANA. 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.