Lanreotide Side Effects

Not all side effects for lanreotide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to lanreotide: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by lanreotide. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking lanreotide:

More common
  • Abdominal fullness
  • blurred vision
  • chest pain or discomfort
  • dizziness
  • gaseous abdominal pain
  • headache
  • lightheadedness, dizziness, or fainting
  • nervousness
  • pale skin
  • pounding in the ears
  • recurrent fever
  • shortness of breath
  • slow, fast, or irregular heartbeat
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Some of the side effects that can occur with lanreotide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bloated, full feeling
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • excess air or gas in stomach or intestines
  • inflammation, itching, lumps, or pain at the injection site
  • muscle pain or stiffness
  • nausea
  • pain in joints
  • passing gas
  • stomach pain
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to lanreotide: subcutaneous solution

Gastrointestinal

One percent of acromegalic patients treated with lanreotide in the pooled clinical studies discontinued treatment because of gastrointestinal reactions.

New cholelithiasis was reported in 12.0% of patients. Cholelithiasis may be related to dose or duration of exposure.

Gastrointestinal side effects including diarrhea (37%), abdominal pain (19%), nausea (11%), constipation (8%), flatulence (7%), vomiting (7%), and loose stools (6%) have been reported (percentages are from overall pooled data). A lethal case of acute necrotizing pancreatitis has also been reported. Postmarketing gastrointestinal side effects including abdominal pain, diarrhea, pancreatitis, and steatorrhea have been reported.

Hepatic

Hepatic side effects including cholelithiasis (20%) and gallbladder sludge (20%), have been reported. Postmarketing hepatic side effects including cholecystitis have been reported.

Local

Local side effects injection site pain (4.1%), injection site mass (1.7%), induration, nodule, and pruritus have been reported. Postmarketing local side effects including injection site reactions have been reported.

Injection site adverse reactions were more commonly reported soon after the start of treatment and were less commonly reported as treatment continued. Such adverse reactions were usually mild or moderate but lead to withdrawal from clinical studies in two subjects.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7%) have been reported. (Percentage is from overall pooled data.)

Nervous system

Nervous system side effects including headache (7%) have been reported. (Percentage is from overall pooled data.)

Cardiovascular

In patients without underlying cardiac disease, lanreotide may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to lanreotide treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with lanreotide in patients with bradycardia.

Cardiovascular side effects including hypertension (5%) and sinus bradycardia (3%) have been reported. (Percentage is from overall pooled data.)

Hematologic

Hematologic side effects including anemia (3%) have been reported. (Percentage is from overall pooled data.)

Metabolic

Metabolic side effects including dysglycemia have been reported. In clinical studies of acromegalic patients treated with lanreotide, adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% of patients and were considered related to study drug in 7% of patients.

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