COLESTIPOL HYDROCHLORIDE

N/A

Manufactured by Pharmacia & Upjohn Company LLC

6,329 FDA adverse event reports analyzed

Last updated: 2026-04-15

About COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. The most commonly reported adverse reactions for COLESTIPOL HYDROCHLORIDE include DIARRHOEA, OFF LABEL USE, NAUSEA, FATIGUE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COLESTIPOL HYDROCHLORIDE.

Top Adverse Reactions

DIARRHOEA358 reports
OFF LABEL USE269 reports
NAUSEA221 reports
FATIGUE210 reports
DRUG INEFFECTIVE169 reports
HEADACHE136 reports
VOMITING125 reports
PAIN118 reports
WEIGHT DECREASED112 reports
ASTHENIA111 reports
DIZZINESS109 reports
ARTHRALGIA106 reports
DYSPNOEA101 reports
CROHN^S DISEASE96 reports
MALAISE94 reports
PRODUCT PHYSICAL ISSUE89 reports
ABDOMINAL PAIN87 reports
PNEUMONIA87 reports
ABDOMINAL PAIN UPPER86 reports
CONDITION AGGRAVATED85 reports
PRODUCT DOSE OMISSION ISSUE83 reports
COUGH77 reports
FALL74 reports
CONSTIPATION71 reports
NASOPHARYNGITIS69 reports
BACK PAIN68 reports
INTENTIONAL PRODUCT USE ISSUE67 reports
ABDOMINAL DISCOMFORT65 reports
ANXIETY65 reports
DECREASED APPETITE65 reports
PRURITUS65 reports
DEHYDRATION62 reports
WEIGHT INCREASED60 reports
RASH59 reports
DYSPHAGIA58 reports
PRODUCT USE COMPLAINT57 reports
SINUSITIS57 reports
URINARY TRACT INFECTION57 reports
PRODUCT USE IN UNAPPROVED INDICATION56 reports
COVID 1955 reports
PYREXIA54 reports
BLOOD PRESSURE INCREASED53 reports
FEELING ABNORMAL53 reports
MUSCLE SPASMS53 reports
DEPRESSION52 reports
ILLNESS51 reports
ARTHRITIS49 reports
HYPOTENSION49 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION49 reports
DEATH48 reports
ABDOMINAL DISTENSION47 reports
INJECTION SITE PAIN47 reports
INTESTINAL OBSTRUCTION47 reports
DRUG HYPERSENSITIVITY46 reports
DYSPEPSIA46 reports
FLATULENCE46 reports
INSOMNIA45 reports
PAIN IN EXTREMITY45 reports
MIGRAINE42 reports
FREQUENT BOWEL MOVEMENTS41 reports
ERYTHEMA40 reports
HYPERTENSION40 reports
HEART RATE INCREASED38 reports
INFLUENZA38 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE38 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION37 reports
HAEMATOCHEZIA37 reports
NEPHROLITHIASIS37 reports
ALOPECIA36 reports
PERIPHERAL SWELLING36 reports
STRESS35 reports
ANAEMIA34 reports
CHOKING34 reports
MYALGIA34 reports
OEDEMA PERIPHERAL34 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS34 reports
CHEST PAIN33 reports
PARAESTHESIA33 reports
ACUTE KIDNEY INJURY32 reports
BLOOD CHOLESTEROL INCREASED32 reports
FLUSHING32 reports
GAIT DISTURBANCE32 reports
LARGE INTESTINAL ULCER32 reports
PRODUCT USE ISSUE32 reports
GASTROOESOPHAGEAL REFLUX DISEASE31 reports
POOR QUALITY PRODUCT ADMINISTERED31 reports
INFECTION30 reports
IRRITABLE BOWEL SYNDROME30 reports
RECTAL HAEMORRHAGE30 reports
EYE PAIN29 reports
FISTULA29 reports
INCORRECT DOSE ADMINISTERED29 reports
PRODUCT SIZE ISSUE29 reports
PRODUCTIVE COUGH29 reports
TREMOR29 reports
VISION BLURRED29 reports
ATRIAL FIBRILLATION28 reports
LOSS OF CONSCIOUSNESS28 reports
NEUROPATHY PERIPHERAL28 reports
SYNCOPE28 reports

Report Outcomes

Out of 2,474 classified reports for COLESTIPOL HYDROCHLORIDE:

Serious 57.8%Non-Serious 42.2%

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

Female1,551 (68.2%)
Male718 (31.6%)
Unknown4 (0.2%)

Reports by Age

Age 7357 reports
Age 6655 reports
Age 7446 reports
Age 5745 reports
Age 6144 reports
Age 6243 reports
Age 5641 reports
Age 7238 reports
Age 6937 reports
Age 7834 reports
Age 5933 reports
Age 6433 reports
Age 6833 reports
Age 6732 reports
Age 7032 reports
Age 6529 reports
Age 7529 reports
Age 5828 reports
Age 7128 reports
Age 7727 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 COLESTIPOL HYDROCHLORIDE?

This profile reflects 6,329 FDA FAERS reports that mention COLESTIPOL HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for COLESTIPOL HYDROCHLORIDE?

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

Who manufactures COLESTIPOL HYDROCHLORIDE?

Labeling and FAERS entries often list Pharmacia & Upjohn Company LLC in connection with COLESTIPOL 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.