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Somatuline Depot Side Effects

Generic Name: lanreotide

Note: This document contains side effect information about lanreotide. Some of the dosage forms listed on this page may not apply to the brand name Somatuline Depot.

In Summary

Common side effects of Somatuline Depot include: diarrhea. Other side effects include: cholelithiasis, hypertension, and sinus bradycardia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lanreotide: subcutaneous solution

Along with its needed effects, lanreotide (the active ingredient contained in Somatuline Depot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lanreotide:

More common
  • Blurred vision
  • chest pain or discomfort
  • dizziness
  • gaseous abdominal or stomach pain
  • headache
  • lightheadedness, dizziness, or fainting
  • nervousness
  • pale skin
  • pounding in the ears
  • recurrent fever
  • slow, fast, or irregular heartbeat
  • stomach fullness
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin
Incidence not known
  • Bloating
  • chills
  • constipation
  • cough
  • dark urine
  • diarrhea
  • difficulty swallowing
  • fast heartbeat
  • fat in the stool
  • fever
  • hives, itching, skin rash
  • indigestion
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe nausea or vomiting
  • stomach pain or cramps
  • sudden loss of weight
  • tightness in the chest
  • vomiting

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

More common
  • Difficulty having a bowel movement
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • feeling of fullness
  • inflammation, itching, lumps, or pain at the injection site
  • muscle pain or stiffness
  • pain in the joints
  • passing gas
  • weight loss

For Healthcare Professionals

Applies to lanreotide: subcutaneous solution

General

The most common adverse events were gastrointestinal disorders, cholelithiasis, and injection site reactions.[Ref]

Gastrointestinal

In one of the studies, diarrhea, abdominal pain, and flatulence increased as the dose increased.[Ref]

Very common (10% or more): Diarrhea (up to 65%), abdominal pain (34%), vomiting (19%), flatulence (14%), nausea (11%), loose stools
Common (1% to 10%): Constipation, flatulence, abdominal distension, abdominal discomfort, dyspepsia
Uncommon (0.1% to 1%): Pancreatitis, feces discolored
Frequency not reported: Steatorrhea[Ref]

Hepatic

Very common (10% or more): Cholelithiasis (27%), bladder sludge (20%), new cholelithiasis
Common (1% to 10%): ALT increased, AST abnormal, ALT abnormal, blood bilirubin increased, biliary dilatation
Uncommon (0.1% to 1%): AST increased, blood alkaline phosphatase increased, blood bilirubin abnormal
Frequency not reported: Cholecystitis[Ref]

Cardiovascular

Very common (10% or more): Bradycardia (18%), hypertension (14%)
Common (1% to 10%): Sinus bradycardia
Uncommon (0.1% to 1%): Other cardiac adverse drug reactions[Ref]

Local

Very common (10% or more): Application site disorder (injection site mass/pain/reaction/inflammation/ nodule/pruritus, 30%)
Postmarketing reports: Persisting induration[Ref]

Metabolic

Very common (10% or more): Dysglycemia (hypoglycemia, hyperglycemia, diabetes, 14%), weight decrease (11%)
Common (1% to 10%): Blood glucose increased, glycosylated hemoglobin increased
Uncommon (0.1% to 1%): Blood sodium decreased, diabetes mellitus aggravated[Ref]

Hematologic

Very common (10% or more): Anemia (14%)[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (19%), arthralgia (11%)[Ref]

Nervous system

Very common (10% or more): Headache (16%)
Common (1% to 10%): Dizziness
Postmarketing reports: Dysautonomia[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

Psychiatric

Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Insomnia[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Hot flush, asthenia
Postmarketing reports: Malaise[Ref]

Immunologic

Common (1% to 10%): Anti-lanreotide (the active ingredient contained in Somatuline Depot) antibodies[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions (including angioedema, anaphylaxis, and hypersensitivity)[Ref]

Dermatologic

Common (1% to 10%): Alopecia, hypotrichosis[Ref]

Endocrine

Rare (less than 0.1%): Clinical hypothyroidism
Frequency not reported: Slight decreases in thyroid function[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Somatuline Depot (lanreotide)." Tercica Inc, Brisbane, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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