LINACLOTIDE

N/A

Manufactured by Allergan, Inc.

49,123 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LINACLOTIDE

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

Top Adverse Reactions

DIARRHOEA4,502 reports
DRUG INEFFECTIVE4,365 reports
OFF LABEL USE3,216 reports
CONSTIPATION1,862 reports
NAUSEA1,373 reports
FATIGUE1,111 reports
ABDOMINAL DISTENSION1,100 reports
ABDOMINAL PAIN1,009 reports
HEADACHE982 reports
PAIN896 reports
ABDOMINAL PAIN UPPER884 reports
DIZZINESS796 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION727 reports
FLATULENCE675 reports
FALL648 reports
MALAISE634 reports
DYSPNOEA633 reports
ASTHENIA603 reports
VOMITING589 reports
PRODUCT DOSE OMISSION ISSUE535 reports
INTENTIONAL PRODUCT MISUSE516 reports
WEIGHT DECREASED489 reports
DEATH482 reports
ANXIETY459 reports
RASH453 reports
ARTHRALGIA451 reports
ABDOMINAL DISCOMFORT444 reports
INCORRECT DOSE ADMINISTERED442 reports
PRURITUS420 reports
MUSCLE SPASMS419 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS414 reports
WEIGHT INCREASED409 reports
DECREASED APPETITE404 reports
INSOMNIA397 reports
FEELING ABNORMAL391 reports
BACK PAIN390 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION386 reports
PRODUCT STORAGE ERROR381 reports
PAIN IN EXTREMITY379 reports
DEPRESSION369 reports
DEHYDRATION367 reports
URINARY TRACT INFECTION363 reports
PNEUMONIA354 reports
CONDITION AGGRAVATED337 reports
CHRONIC KIDNEY DISEASE330 reports
DRUG DOSE OMISSION329 reports
SOMNOLENCE317 reports
COVID 19289 reports
GAIT DISTURBANCE289 reports
ILLNESS288 reports
CHEST PAIN283 reports
PERIPHERAL SWELLING280 reports
COUGH276 reports
PRODUCT USE IN UNAPPROVED INDICATION275 reports
THERAPEUTIC RESPONSE DECREASED265 reports
TREMOR265 reports
PRODUCT DISPENSING ERROR256 reports
GASTROINTESTINAL DISORDER252 reports
PYREXIA251 reports
SINUSITIS243 reports
GASTROOESOPHAGEAL REFLUX DISEASE238 reports
HYPERTENSION238 reports
MIGRAINE238 reports
DYSPEPSIA237 reports
UNEVALUABLE EVENT234 reports
PRODUCT USE ISSUE233 reports
ACUTE KIDNEY INJURY232 reports
MEMORY IMPAIRMENT232 reports
BLOOD PRESSURE INCREASED229 reports
RENAL FAILURE218 reports
ALOPECIA217 reports
CONFUSIONAL STATE208 reports
HYPOAESTHESIA200 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION198 reports
HALLUCINATION188 reports
SURGERY188 reports
THERAPEUTIC PRODUCT EFFECT DECREASED188 reports
HYPERSENSITIVITY187 reports
DRUG HYPERSENSITIVITY186 reports
NASOPHARYNGITIS186 reports
PALPITATIONS184 reports
HYPERHIDROSIS182 reports
DYSPHAGIA177 reports
MYALGIA177 reports
HYPOTENSION174 reports
SEIZURE172 reports
BOWEL MOVEMENT IRREGULARITY171 reports
BALANCE DISORDER165 reports
HOSPITALISATION165 reports
INFECTION163 reports
ANAL INCONTINENCE161 reports
EXPIRED PRODUCT ADMINISTERED161 reports
PRODUCT DOSE OMISSION160 reports
URTICARIA160 reports
VISION BLURRED160 reports
GASTROINTESTINAL MOTILITY DISORDER156 reports
MUSCULAR WEAKNESS156 reports
PARAESTHESIA154 reports
CONTUSION153 reports
FREQUENT BOWEL MOVEMENTS153 reports

Report Outcomes

Out of 24,973 classified reports for LINACLOTIDE:

Serious 35.4%Non-Serious 64.6%

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

Female16,594 (72.7%)
Male6,185 (27.1%)
Unknown61 (0.3%)

Reports by Age

Age 72297 reports
Age 68294 reports
Age 70292 reports
Age 62277 reports
Age 65277 reports
Age 60276 reports
Age 64270 reports
Age 59261 reports
Age 71260 reports
Age 74260 reports
Age 69259 reports
Age 63256 reports
Age 67254 reports
Age 66253 reports
Age 77252 reports
Age 75249 reports
Age 76249 reports
Age 58245 reports
Age 61241 reports
Age 55234 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 LINACLOTIDE?

This profile reflects 49,123 FDA FAERS reports that mention LINACLOTIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LINACLOTIDE?

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

Who manufactures LINACLOTIDE?

Labeling and FAERS entries often list Allergan, Inc. in connection with LINACLOTIDE. 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.