LANREOTIDE ACETATE

N/A

Manufactured by Ipsen Biopharmaceuticals, Inc.

20,256 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LANREOTIDE ACETATE

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

Top Adverse Reactions

OFF LABEL USE1,351 reports
DIARRHOEA1,334 reports
DEATH1,107 reports
FATIGUE897 reports
NAUSEA680 reports
INJECTION SITE PAIN564 reports
ABDOMINAL PAIN523 reports
HEADACHE474 reports
MALAISE402 reports
ASTHENIA386 reports
DIZZINESS385 reports
PAIN371 reports
INJECTION SITE MASS355 reports
WEIGHT DECREASED353 reports
PRODUCT DOSE OMISSION ISSUE344 reports
VOMITING336 reports
DRUG INEFFECTIVE299 reports
ABDOMINAL PAIN UPPER290 reports
MALIGNANT NEOPLASM PROGRESSION282 reports
CONSTIPATION280 reports
FLATULENCE258 reports
ARTHRALGIA251 reports
DECREASED APPETITE250 reports
ABDOMINAL DISTENSION246 reports
ABDOMINAL DISCOMFORT244 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION228 reports
BLOOD GLUCOSE INCREASED218 reports
DYSPNOEA215 reports
ALOPECIA211 reports
HYPERTENSION208 reports
FLUSHING201 reports
FALL196 reports
HOSPITALISATION192 reports
BACK PAIN190 reports
DISEASE PROGRESSION157 reports
PAIN IN EXTREMITY156 reports
BLOOD PRESSURE INCREASED149 reports
ANXIETY148 reports
FEELING ABNORMAL140 reports
NEOPLASM PROGRESSION137 reports
PYREXIA137 reports
WEIGHT INCREASED137 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION135 reports
CHOLELITHIASIS131 reports
MUSCLE SPASMS128 reports
COVID 19122 reports
HYPOTENSION122 reports
PERIPHERAL SWELLING122 reports
INSOMNIA118 reports
CHEST PAIN111 reports
CONDITION AGGRAVATED111 reports
DEHYDRATION107 reports
MYALGIA104 reports
GASTROINTESTINAL DISORDER103 reports
HYPERHIDROSIS103 reports
INJECTION SITE HAEMORRHAGE102 reports
URINARY TRACT INFECTION102 reports
COUGH99 reports
DEPRESSION98 reports
INSULIN LIKE GROWTH FACTOR INCREASED98 reports
ILLNESS97 reports
HEART RATE DECREASED96 reports
LOSS OF CONSCIOUSNESS95 reports
BLOOD GLUCOSE DECREASED92 reports
HYPOGLYCAEMIA90 reports
OEDEMA PERIPHERAL90 reports
GAIT DISTURBANCE88 reports
PRURITUS88 reports
INJECTION SITE NODULE87 reports
SYNCOPE85 reports
METASTASES TO LIVER83 reports
HOT FLUSH82 reports
CONTUSION80 reports
GENERAL PHYSICAL HEALTH DETERIORATION79 reports
HEART RATE INCREASED78 reports
INJECTION SITE PRURITUS77 reports
DYSPEPSIA76 reports
INTESTINAL OBSTRUCTION73 reports
NASOPHARYNGITIS72 reports
NEPHROLITHIASIS71 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS71 reports
NEEDLE ISSUE70 reports
PNEUMONIA70 reports
ANAEMIA68 reports
DIABETES MELLITUS68 reports
SOMNOLENCE68 reports
RASH67 reports
HEPATIC NEOPLASM65 reports
ADVERSE EVENT64 reports
CHILLS63 reports
STRESS63 reports
BRADYCARDIA62 reports
FAECES DISCOLOURED62 reports
HYPOAESTHESIA61 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES61 reports
TREMOR60 reports
CONFUSIONAL STATE59 reports
FREQUENT BOWEL MOVEMENTS59 reports
LIVER DISORDER59 reports
PALPITATIONS59 reports

Report Outcomes

Out of 7,402 classified reports for LANREOTIDE ACETATE:

Serious 57.6%Non-Serious 42.4%

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

Female3,896 (55.0%)
Male3,181 (44.9%)
Unknown1 (0.0%)

Reports by Age

Age 63170 reports
Age 62159 reports
Age 60152 reports
Age 64152 reports
Age 58150 reports
Age 56141 reports
Age 61140 reports
Age 59135 reports
Age 57133 reports
Age 55131 reports
Age 52118 reports
Age 66116 reports
Age 65115 reports
Age 70114 reports
Age 71108 reports
Age 53106 reports
Age 68105 reports
Age 54103 reports
Age 6999 reports
Age 7297 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 LANREOTIDE ACETATE?

This profile reflects 20,256 FDA FAERS reports that mention LANREOTIDE ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LANREOTIDE ACETATE?

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

Who manufactures LANREOTIDE ACETATE?

Labeling and FAERS entries often list Ipsen Biopharmaceuticals, Inc. in connection with LANREOTIDE ACETATE. 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.