COLESEVELAM HYDROCHLORIDE

N/A

Manufactured by Cosette Pharmaceuticals, Inc.

19,165 FDA adverse event reports analyzed

Last updated: 2026-04-14

About COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cosette Pharmaceuticals, Inc.. The most commonly reported adverse reactions for COLESEVELAM HYDROCHLORIDE include OFF LABEL USE, NO ADVERSE EVENT, DIARRHOEA, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COLESEVELAM HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE1,384 reports
NO ADVERSE EVENT922 reports
DIARRHOEA682 reports
NAUSEA511 reports
FATIGUE503 reports
DRUG INEFFECTIVE482 reports
CONSTIPATION394 reports
DYSPNOEA380 reports
HEADACHE367 reports
MUSCLE SPASMS338 reports
PAIN332 reports
ARTHRALGIA315 reports
DIZZINESS298 reports
WEIGHT DECREASED295 reports
MYALGIA292 reports
PRURITUS265 reports
COUGH258 reports
ASTHENIA257 reports
FLUSHING242 reports
INCORRECT DOSE ADMINISTERED241 reports
PAIN IN EXTREMITY236 reports
MALAISE235 reports
VOMITING235 reports
BACK PAIN222 reports
FALL213 reports
NASOPHARYNGITIS213 reports
ABDOMINAL PAIN197 reports
ATRIAL FIBRILLATION193 reports
ABDOMINAL DISCOMFORT183 reports
RASH181 reports
DRUG ADMINISTRATION ERROR177 reports
ABDOMINAL PAIN UPPER171 reports
FEELING ABNORMAL171 reports
CHEST DISCOMFORT166 reports
DYSPHAGIA166 reports
CEREBROVASCULAR ACCIDENT163 reports
CHEST PAIN162 reports
INSOMNIA160 reports
INJECTION SITE PAIN157 reports
ANXIETY156 reports
PNEUMONIA155 reports
DYSPHONIA153 reports
DRUG HYPERSENSITIVITY149 reports
BLOOD CHOLESTEROL INCREASED148 reports
ABDOMINAL DISTENSION147 reports
BLOOD GLUCOSE INCREASED146 reports
CARDIAC DISORDER146 reports
CHRONIC KIDNEY DISEASE146 reports
DYSPEPSIA137 reports
CORONARY ARTERY DISEASE136 reports
MYOCARDIAL INFARCTION136 reports
RENAL FAILURE136 reports
GAIT DISTURBANCE132 reports
GASTROOESOPHAGEAL REFLUX DISEASE132 reports
DYSPNOEA EXERTIONAL130 reports
HYPERTENSION128 reports
FLATULENCE127 reports
DECREASED APPETITE126 reports
WEIGHT INCREASED126 reports
WHEEZING126 reports
DEPRESSION123 reports
DEATH121 reports
PARAESTHESIA120 reports
ACUTE KIDNEY INJURY116 reports
URINARY TRACT INFECTION114 reports
DRUG DOSE OMISSION112 reports
SENSATION OF FOREIGN BODY112 reports
BLOOD PRESSURE INCREASED110 reports
OBSTRUCTIVE AIRWAYS DISORDER110 reports
EOSINOPHILIA109 reports
MYOGLOBIN BLOOD INCREASED109 reports
BRAIN NATRIURETIC PEPTIDE INCREASED108 reports
FRACTIONAL EXHALED NITRIC OXIDE INCREASED107 reports
PLANTAR FASCIITIS107 reports
PYREXIA107 reports
SINUSITIS107 reports
MUSCULAR WEAKNESS103 reports
EXOSTOSIS102 reports
ALOPECIA100 reports
CONDITION AGGRAVATED100 reports
DEHYDRATION99 reports
FEELING HOT99 reports
ERYTHEMA96 reports
URTICARIA94 reports
HYPOAESTHESIA93 reports
OBSTRUCTIVE SLEEP APNOEA SYNDROME93 reports
PNEUMOTHORAX93 reports
PERIPHERAL SWELLING91 reports
SOMNOLENCE91 reports
SECRETION DISCHARGE89 reports
OEDEMA PERIPHERAL86 reports
TREMOR82 reports
INFLUENZA LIKE ILLNESS76 reports
CONFUSIONAL STATE74 reports
HYPOTENSION74 reports
NEUROPATHY PERIPHERAL73 reports
OROPHARYNGEAL PAIN73 reports
ARTHRITIS72 reports
HYPERSENSITIVITY72 reports
CONTUSION71 reports

Report Outcomes

Out of 9,095 classified reports for COLESEVELAM HYDROCHLORIDE:

Serious 42.4%Non-Serious 57.6%

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

Female5,387 (64.9%)
Male2,884 (34.7%)
Unknown30 (0.4%)

Reports by Age

Age 66162 reports
Age 68150 reports
Age 60149 reports
Age 65147 reports
Age 77144 reports
Age 69143 reports
Age 72143 reports
Age 62139 reports
Age 70139 reports
Age 73132 reports
Age 74128 reports
Age 63124 reports
Age 67124 reports
Age 64119 reports
Age 71115 reports
Age 59104 reports
Age 76104 reports
Age 54102 reports
Age 6195 reports
Age 5889 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 COLESEVELAM HYDROCHLORIDE?

This profile reflects 19,165 FDA FAERS reports that mention COLESEVELAM HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for COLESEVELAM HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, NO ADVERSE EVENT, DIARRHOEA, NAUSEA, FATIGUE, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures COLESEVELAM HYDROCHLORIDE?

Labeling and FAERS entries often list Cosette Pharmaceuticals, Inc. in connection with COLESEVELAM 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.