CLADRIBINE

N/A

Manufactured by EMD Serono, Inc.

13,464 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CLADRIBINE

CLADRIBINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by EMD Serono, Inc.. The most commonly reported adverse reactions for CLADRIBINE include FATIGUE, HEADACHE, LYMPHOCYTE COUNT DECREASED, MULTIPLE SCLEROSIS RELAPSE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLADRIBINE.

Top Adverse Reactions

FATIGUE769 reports
HEADACHE631 reports
LYMPHOCYTE COUNT DECREASED461 reports
MULTIPLE SCLEROSIS RELAPSE451 reports
NAUSEA399 reports
PNEUMONIA375 reports
WHITE BLOOD CELL COUNT DECREASED334 reports
OFF LABEL USE320 reports
PYREXIA281 reports
DRUG INEFFECTIVE280 reports
URINARY TRACT INFECTION265 reports
MULTIPLE SCLEROSIS238 reports
ASTHENIA222 reports
LYMPHOPENIA216 reports
FEBRILE NEUTROPENIA206 reports
COVID 19192 reports
PAIN181 reports
DIARRHOEA180 reports
DIZZINESS174 reports
NEUTROPENIA170 reports
DEATH169 reports
FALL168 reports
SEPSIS166 reports
GAIT DISTURBANCE163 reports
PANCYTOPENIA162 reports
VOMITING153 reports
THROMBOCYTOPENIA145 reports
INFECTION141 reports
LOWER RESPIRATORY TRACT INFECTION136 reports
WEIGHT DECREASED133 reports
RASH129 reports
MALAISE128 reports
DYSPNOEA126 reports
ALOPECIA124 reports
NASOPHARYNGITIS121 reports
CONDITION AGGRAVATED116 reports
PRODUCT USE IN UNAPPROVED INDICATION116 reports
LEUKOPENIA115 reports
HERPES ZOSTER114 reports
ARTHRALGIA112 reports
ALANINE AMINOTRANSFERASE INCREASED111 reports
ANAEMIA110 reports
HYPOAESTHESIA110 reports
BACK PAIN108 reports
FEELING ABNORMAL103 reports
DECREASED APPETITE99 reports
INSOMNIA99 reports
MUSCULAR WEAKNESS99 reports
ASPARTATE AMINOTRANSFERASE INCREASED98 reports
PAIN IN EXTREMITY97 reports
PRURITUS97 reports
BALANCE DISORDER93 reports
RASH MACULO PAPULAR91 reports
LOSS OF CONSCIOUSNESS89 reports
PARAESTHESIA88 reports
COUGH86 reports
HYPOTENSION86 reports
WEIGHT INCREASED86 reports
DISEASE PROGRESSION85 reports
ABDOMINAL PAIN82 reports
MYELODYSPLASTIC SYNDROME82 reports
MATERNAL EXPOSURE BEFORE PREGNANCY80 reports
INFLUENZA77 reports
MYALGIA77 reports
MEMORY IMPAIRMENT71 reports
CEREBROVASCULAR ACCIDENT70 reports
MIGRAINE70 reports
ABDOMINAL DISCOMFORT69 reports
CONSTIPATION68 reports
NEUTROPHIL COUNT DECREASED68 reports
SEPTIC SHOCK67 reports
ABDOMINAL PAIN UPPER66 reports
PLATELET COUNT DECREASED65 reports
SEIZURE65 reports
HYPERSENSITIVITY64 reports
URTICARIA63 reports
MYOCARDIAL INFARCTION62 reports
HYPERTENSION60 reports
INFLUENZA LIKE ILLNESS60 reports
ANXIETY59 reports
MOBILITY DECREASED59 reports
NEPHROLITHIASIS59 reports
VERTIGO59 reports
CHEST PAIN58 reports
MYELOSUPPRESSION58 reports
SINUSITIS58 reports
UPPER RESPIRATORY TRACT INFECTION58 reports
PULMONARY EMBOLISM57 reports
DEHYDRATION56 reports
VISUAL IMPAIRMENT56 reports
ABORTION SPONTANEOUS55 reports
HYPOTHYROIDISM55 reports
MUSCLE SPASMS55 reports
RESPIRATORY FAILURE55 reports
ACUTE MYELOID LEUKAEMIA53 reports
GENERAL PHYSICAL HEALTH DETERIORATION52 reports
SYNCOPE51 reports
PERIPHERAL SWELLING50 reports
CHILLS49 reports
DEPRESSION49 reports

Report Outcomes

Out of 8,842 classified reports for CLADRIBINE:

Serious 75.1%Non-Serious 24.9%

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

Female5,633 (69.0%)
Male2,492 (30.5%)
Unknown33 (0.4%)

Reports by Age

Age 51155 reports
Age 54148 reports
Age 42143 reports
Age 53137 reports
Age 46136 reports
Age 57136 reports
Age 40135 reports
Age 45135 reports
Age 48135 reports
Age 49130 reports
Age 44128 reports
Age 50128 reports
Age 55123 reports
Age 43119 reports
Age 52117 reports
Age 47116 reports
Age 39115 reports
Age 41115 reports
Age 58115 reports
Age 33113 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 CLADRIBINE?

This profile reflects 13,464 FDA FAERS reports that mention CLADRIBINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CLADRIBINE?

Frequently reported terms in FAERS include FATIGUE, HEADACHE, LYMPHOCYTE COUNT DECREASED, MULTIPLE SCLEROSIS RELAPSE, NAUSEA, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CLADRIBINE?

Labeling and FAERS entries often list EMD Serono, Inc. in connection with CLADRIBINE. 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.