CEVIMELINE HYDROCHLORIDE

N/A

Manufactured by Aurobindo Pharma Limited

5,260 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for CEVIMELINE HYDROCHLORIDE include DRUG INEFFECTIVE, HEADACHE, NAUSEA, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEVIMELINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE203 reports
HEADACHE167 reports
NAUSEA160 reports
DIARRHOEA159 reports
FATIGUE149 reports
DYSPNOEA135 reports
PAIN125 reports
ARTHRALGIA117 reports
FALL106 reports
OFF LABEL USE103 reports
MALAISE96 reports
DIZZINESS93 reports
VOMITING90 reports
PNEUMONIA85 reports
DRY MOUTH83 reports
CONDITION AGGRAVATED79 reports
PAIN IN EXTREMITY79 reports
COUGH77 reports
RASH77 reports
WEIGHT DECREASED75 reports
PRODUCT DOSE OMISSION ISSUE72 reports
URINARY TRACT INFECTION69 reports
PYREXIA67 reports
ASTHENIA62 reports
PRURITUS61 reports
BACK PAIN59 reports
SINUSITIS59 reports
FEELING ABNORMAL57 reports
ANXIETY55 reports
CONSTIPATION55 reports
WEIGHT INCREASED55 reports
INSOMNIA54 reports
INJECTION SITE PAIN53 reports
DRUG HYPERSENSITIVITY52 reports
EYE PAIN52 reports
JOINT SWELLING49 reports
NASOPHARYNGITIS49 reports
ABDOMINAL PAIN UPPER48 reports
COVID 1946 reports
DEPRESSION45 reports
ABDOMINAL PAIN44 reports
DRY EYE44 reports
GAIT DISTURBANCE44 reports
DEHYDRATION43 reports
HYPERTENSION43 reports
RHEUMATOID ARTHRITIS43 reports
CHEST PAIN41 reports
DEATH41 reports
HYPOTENSION40 reports
ERYTHEMA39 reports
HYPERHIDROSIS39 reports
ANAEMIA38 reports
BRONCHITIS37 reports
GASTROOESOPHAGEAL REFLUX DISEASE37 reports
SJOGREN^S SYNDROME35 reports
MUSCLE SPASMS34 reports
PERIPHERAL SWELLING34 reports
BLOOD PRESSURE INCREASED33 reports
MIGRAINE33 reports
SOMNOLENCE33 reports
INCORRECT DOSE ADMINISTERED32 reports
INFECTION32 reports
TREMOR32 reports
UNEVALUABLE EVENT32 reports
DECREASED APPETITE31 reports
HYPOAESTHESIA31 reports
OSTEOARTHRITIS31 reports
HERPES ZOSTER30 reports
ILLNESS30 reports
OROPHARYNGEAL PAIN30 reports
PARAESTHESIA30 reports
ABDOMINAL DISCOMFORT29 reports
DRUG DOSE OMISSION29 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION29 reports
INFLUENZA29 reports
OEDEMA PERIPHERAL29 reports
PALPITATIONS29 reports
SYSTEMIC LUPUS ERYTHEMATOSUS29 reports
ALOPECIA28 reports
CHILLS28 reports
EYE IRRITATION28 reports
CONTUSION27 reports
MEMORY IMPAIRMENT27 reports
SEPSIS27 reports
GASTROINTESTINAL DISORDER26 reports
PLEURAL EFFUSION26 reports
RENAL FAILURE26 reports
UPPER RESPIRATORY TRACT INFECTION26 reports
DYSPHONIA25 reports
INJECTION SITE ERYTHEMA25 reports
NO ADVERSE EVENT25 reports
PRODUCT USE IN UNAPPROVED INDICATION25 reports
PRODUCT USE ISSUE25 reports
PSORIASIS25 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS25 reports
ACUTE KIDNEY INJURY24 reports
DYSPHAGIA24 reports
MUSCULOSKELETAL STIFFNESS24 reports
MYALGIA24 reports
STOMATITIS24 reports

Report Outcomes

Out of 2,581 classified reports for CEVIMELINE HYDROCHLORIDE:

Serious 53.5%Non-Serious 46.5%

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

Female2,147 (88.4%)
Male279 (11.5%)
Unknown2 (0.1%)

Reports by Age

Age 6467 reports
Age 6164 reports
Age 6561 reports
Age 6258 reports
Age 6056 reports
Age 5754 reports
Age 6953 reports
Age 6651 reports
Age 6349 reports
Age 6748 reports
Age 5847 reports
Age 5944 reports
Age 5243 reports
Age 7243 reports
Age 5341 reports
Age 7041 reports
Age 7138 reports
Age 5537 reports
Age 5436 reports
Age 7435 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 CEVIMELINE HYDROCHLORIDE?

This profile reflects 5,260 FDA FAERS reports that mention CEVIMELINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CEVIMELINE HYDROCHLORIDE?

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

Who manufactures CEVIMELINE HYDROCHLORIDE?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with CEVIMELINE HYDROCHLORIDE. 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.