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Sandostatin LAR Depot Side Effects

Generic Name: octreotide

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

For the Consumer

Applies to octreotide: powder for solution, powder for suspension, solution

Along with its needed effects, octreotide (the active ingredient contained in Sandostatin LAR 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 or nurse immediately if any of the following side effects occur while taking octreotide:

More Common

Less Common or Rare

  • Abdominal or stomach bloating
  • anxious feeling
  • behavior change similar to drunkenness
  • changes in menstrual periods
  • cold sweats
  • confusion
  • convulsions (seizures)
  • cool, pale skin
  • decreased sexual ability in males
  • difficulty with concentrating
  • drowsiness
  • headache
  • loss of appetite
  • muscle cramps and stiffness
  • nightmares
  • restless sleep
  • shakiness
  • slurred speech
  • swelling of the front part of the neck
  • tiredness
  • troubled breathing (rapid and deep)
  • unconsciousness
  • unusual thirst

Incidence Not Known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chills
  • darkened urine
  • fever
  • indigestion
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • severe constipation
  • unusual bleeding or bruising
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking octreotide:

Symptoms of Overdose

  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, shallow breathing
  • feeling of warmth
  • general feeling of discomfort
  • light-colored stools
  • muscle pain or cramping
  • no blood pressure or pulse
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • sleepiness
  • stopping of heart
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • upper right abdominal or stomach pain
  • weakness
  • weight loss

Some side effects of octreotide 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

  • Pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
  • passing of gas

Less Common or Rare

  • Backache
  • bladder pain
  • cloudy urine
  • cough
  • difficult, burning, or painful urination
  • disturbed color perception
  • double vision
  • frequent urge to urinate
  • frequent urination usually with very small amounts of urine
  • general feeling of discomfort or illness
  • halos around lights
  • itching skin
  • joint pain
  • lack of appetite
  • loss of vision
  • lower back or side pain
  • muscle aches and pains
  • night blindness
  • overbright appearance of lights
  • runny nose
  • shivering
  • sore throat
  • stools that float, are foul smelling, and fatty in appearance
  • trouble concentrating
  • trouble sleeping
  • tunnel vision

For Healthcare Professionals

Applies to octreotide: injectable solution, intramuscular powder for injection extended release

General

The most common adverse events were gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (57.9%), abdominal pain (43.9%), nausea (29.8%), flatulence (25.3%), constipation (18.8%), abdominal pain upper (10.5%), abdominal discomfort, loose stools

Common (1% to 10%): Fat malabsorption, vomiting, dyspepsia, steatorrhea, discoloration of feces, tenesmus, abdominal distension

Uncommon (0.1% to 1%): GI bleeding, hemorrhoids, appendicitis, gastric/peptic ulcer

Frequency not reported: Pancreatitis, vomiting, abnormal stools, severe epigastric pain, abdominal tenderness and guarding

Postmarketing reports: Intestinal obstruction[Ref]

Cardiovascular

Very common (10% or more): Bradycardia (25%), hypertension (12.6%), conduction abnormalities (10%)

Common (1% to 10%): Arrhythmias, flushing

Uncommon (0.1% to 1%): Chest pain, shortness of breath, thrombophlebitis, ischemia, congestive heart failure, palpitations, orthostatic blood pressure decrease, tachycardia[Ref]

Hepatic

Very common (10% or more): Gallstones (27%), sludge without stones (24%), cholelithiasis (38.2%), biliary duct dilatation (12%)

Common (1% to 10%): Transaminase increased

Uncommon (0.1% to 1%): Hepatitis, jaundice, increase in liver enzymes, gallbladder polyp

Rare (less than 0.1%): Acute pancreatitis

Frequency not reported: Acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (30%), dizziness (20%)

Uncommon (0.1% to 1%): Syncope, tremor, seizure, vertigo, Bell's palsy, pituitary apoplexy, amnesia, neuritis[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (16%)

Common (1% to 10%): Hypoglycemia, edema, anorexia

Uncommon (0.1% to 1%): Weight loss, dehydration

Frequency not reported: Depressed vitamin B12 levels, abnormal Schilling's test[Ref]

Hematologic

Very common (10% or more): Anemia (15.3%)

Uncommon (0.1% to 1%): Iron deficiency

Postmarketing reports: Thrombocytopenia[Ref]

Endocrine

Very common (10% or more): Biochemical hypothyroidism (12%)

Common (1% to 10%): Goiter, thyroid dysfunction (e.g. decreased TSH, decreased Total T4, and decreased Free T4)

Uncommon (0.1% to 1%): Galactorrhea, hypoadrenalism, diabetes insipidus[Ref]

Local

Very common (10% or more): Injection site pain (13.8%), injection site reactions

Common (1% to 10%): Injection site hematoma[Ref]

Dermatologic

Very common (10% or more): Alopecia (13.2%)

Common (1% to 10%): Pruritus, bruise, rash

Uncommon (0.1% to 1%): Cellulitis, petechiae, urticaria, basal cell carcinoma[Ref]

Musculoskeletal

Common (1% to 10%): Joint pain, backache

Uncommon (0.1% to 1%): Arthritis, joint effusion, muscle pain, Raynaud's phenomenon[Ref]

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Anxiety, paranoia, libido decrease[Ref]

Other

Very common (10% or more): Fatigue (31.8%), generalized pain (15%)

Common (1% to 10%): Weakness

Uncommon (0.1% to 1%): Hearing loss, otitis[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (18.2%), sinusitis (12%)

Common (1% to 10%): Cold symptoms, flu symptoms, epistaxis

Uncommon (0.1% to 1%): Pneumonia, pulmonary nodule, status asthmaticus[Ref]

Renal

Uncommon (0.1% to 1%): Increased creatinine kinase[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction

Frequency not reported: Anaphylactic reaction[Ref]

Immunologic

Very common (10% or more): Antibodies to octreotide (the active ingredient contained in Sandostatin LAR Depot) (25%)

Ocular

Common (1% to 10%): Blurred vision, visual disturbance

Uncommon (0.1% to 1%): Increased intraocular pressure[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, pollakiuria

Uncommon (0.1% to 1%): Gynecomastia, amenorrhea, polymenorrhea, oligomenorrhea, vaginitis, nephrolithiasis, hematuria[Ref]

References

1. "Product Information. Octreotide Acetate (octreotide)." Teva SICOR Pharmaceuticals Inc, Irvine, CA.

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

3. "Product Information. Sandostatin (octreotide)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

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

5. "Product Information. SandoSTATIN LAR Depot (octreotide)." Novartis Consumer Health, Parsippany, NJ.

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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