PRUCALOPRIDE

N/A

Manufactured by Takeda Pharmaceuticals America, Inc.

4,835 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PRUCALOPRIDE

PRUCALOPRIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. The most commonly reported adverse reactions for PRUCALOPRIDE include DRUG INEFFECTIVE, HEADACHE, NAUSEA, NO ADVERSE EVENT, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PRUCALOPRIDE.

Top Adverse Reactions

DRUG INEFFECTIVE252 reports
HEADACHE230 reports
NAUSEA185 reports
NO ADVERSE EVENT171 reports
DIARRHOEA156 reports
OFF LABEL USE154 reports
CONSTIPATION126 reports
FATIGUE126 reports
INABILITY TO AFFORD MEDICATION120 reports
DIZZINESS117 reports
PRODUCT USE ISSUE106 reports
VOMITING98 reports
ABDOMINAL PAIN97 reports
INSURANCE ISSUE92 reports
PAIN73 reports
ABDOMINAL DISTENSION72 reports
DEPRESSION70 reports
PRODUCT DOSE OMISSION ISSUE69 reports
PRODUCT USE IN UNAPPROVED INDICATION67 reports
MALAISE61 reports
FEELING ABNORMAL60 reports
ANXIETY57 reports
DYSPNOEA57 reports
ABDOMINAL DISCOMFORT55 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS55 reports
ABDOMINAL PAIN UPPER53 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION53 reports
FALL52 reports
CONDITION AGGRAVATED51 reports
MIGRAINE51 reports
WEIGHT DECREASED48 reports
RASH44 reports
ASTHENIA43 reports
DECREASED APPETITE43 reports
MUSCLE SPASMS43 reports
SUICIDAL IDEATION42 reports
VISION BLURRED41 reports
COVID 1940 reports
FLATULENCE40 reports
IMPAIRED GASTRIC EMPTYING40 reports
PRODUCT AVAILABILITY ISSUE40 reports
ILLNESS38 reports
PRURITUS38 reports
INSOMNIA37 reports
DEATH35 reports
ARTHRALGIA33 reports
INTENTIONAL PRODUCT USE ISSUE33 reports
INCORRECT DOSE ADMINISTERED32 reports
BACK PAIN31 reports
GASTROINTESTINAL DISORDER30 reports
SOMNOLENCE30 reports
WEIGHT INCREASED30 reports
COUGH29 reports
CHEST PAIN28 reports
PARAESTHESIA28 reports
PRODUCT PRESCRIBING ISSUE28 reports
HOSPITALISATION27 reports
BOWEL MOVEMENT IRREGULARITY26 reports
PALPITATIONS26 reports
THERAPEUTIC PRODUCT EFFECT DECREASED26 reports
CONFUSIONAL STATE25 reports
PITUITARY TUMOUR BENIGN25 reports
PYREXIA25 reports
SINUSITIS25 reports
URINARY TRACT INFECTION25 reports
PERIPHERAL SWELLING24 reports
PNEUMONIA24 reports
THERAPY INTERRUPTED24 reports
DRUG INTERACTION23 reports
SEIZURE23 reports
MYALGIA22 reports
HALLUCINATION21 reports
HYPERTENSION21 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES21 reports
PAIN IN EXTREMITY21 reports
TREMOR21 reports
ADVERSE DRUG REACTION20 reports
HYPERPROLACTINAEMIA20 reports
INFECTION20 reports
BLOOD PRESSURE INCREASED19 reports
DEPRESSED MOOD19 reports
DYSPHAGIA19 reports
INTESTINAL OBSTRUCTION19 reports
NASOPHARYNGITIS19 reports
TACHYCARDIA19 reports
EYE PAIN18 reports
HYPOAESTHESIA18 reports
LETHARGY18 reports
MEMORY IMPAIRMENT18 reports
SLEEP DISORDER18 reports
CONTUSION17 reports
DYSPEPSIA17 reports
HEART RATE INCREASED17 reports
HYPERHIDROSIS17 reports
SECONDARY ADRENOCORTICAL INSUFFICIENCY17 reports
VITAMIN D DEFICIENCY17 reports
ADRENAL INSUFFICIENCY16 reports
ERYTHEMA16 reports
GAIT DISTURBANCE16 reports
GASTROINTESTINAL MOTILITY DISORDER16 reports

Report Outcomes

Out of 2,108 classified reports for PRUCALOPRIDE:

Serious 44.7%Non-Serious 55.3%

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

Female1,377 (78.1%)
Male382 (21.7%)
Unknown4 (0.2%)

Reports by Age

Age 2130 reports
Age 6329 reports
Age 6726 reports
Age 5623 reports
Age 7122 reports
Age 6021 reports
Age 5420 reports
Age 4819 reports
Age 5818 reports
Age 5918 reports
Age 6918 reports
Age 4317 reports
Age 6117 reports
Age 6517 reports
Age 6617 reports
Age 7017 reports
Age 4416 reports
Age 6216 reports
Age 6416 reports
Age 3015 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 PRUCALOPRIDE?

This profile reflects 4,835 FDA FAERS reports that mention PRUCALOPRIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PRUCALOPRIDE?

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

Who manufactures PRUCALOPRIDE?

Labeling and FAERS entries often list Takeda Pharmaceuticals America, Inc. in connection with PRUCALOPRIDE. 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.