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Octreotide Side Effects

In Summary

Commonly reported side effects of octreotide include: cardiac conduction disorder, gallbladder sludge, and hyperglycemia. Other side effects include: cardiac arrhythmia, and hypoglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to octreotide: powder for suspension, solution

Side effects requiring immediate medical attention

Along with its needed effects, octreotide 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 octreotide:

More common

Less common

  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • cold sweats
  • collection of blood under the skin
  • confusion
  • cool, pale skin
  • deep, dark purple bruise
  • difficult, burning, or painful urination
  • dry mouth
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • itching, pain, redness, or swelling
  • loss of consciousness
  • lower back or side pain
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • sweating
  • swelling
  • troubled breathing
  • unexplained weight loss

Rare

  • Black, tarry stools
  • bleeding gums
  • blood in vomit
  • changes in skin color, pain, tenderness, swelling of the foot or leg
  • chest pain
  • cough
  • coughing up blood
  • dark urine
  • decreased urine output
  • difficulty in breathing or swallowing
  • difficulty swallowing
  • dilated neck veins
  • extreme tiredness or weakness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • hives, itching, skin rash
  • increased menstrual flow or vaginal bleeding
  • irregular breathing
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • light-colored stools
  • nosebleeds
  • pain in the groin or genitals
  • pale skin
  • paleness or cold feeling in the fingertips and toes
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red or dark brown urine
  • severe or continuing stomach pain
  • sharp back pain just below the ribs
  • sneezing
  • sore throat
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • tingling or pain in the fingers or toes when exposed to cold temperatures
  • tremor
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • upper right abdominal pain
  • yellow eyes and skin

Incidence not known

  • Bloating
  • gaseous
  • indigestion
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • recurrent fever
  • severe constipation
  • stomach fullness

Side effects not requiring immediate medical attention

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

  • Abnormal stool
  • excess air or gas in the stomach or bowels
  • full feeling
  • pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
  • passing of gas

Less common

  • Backache
  • feeling of warmth
  • hair loss
  • joint pain
  • redness of the face, neck, arms and occasionally, upper chest

Rare

  • Absent, missed, or irregular menstrual periods
  • change in vision
  • difficulty in moving
  • feeling of constant movement of self or surroundings
  • hearing loss
  • itching of the vagina or genital area
  • joint swelling or redness
  • loss of vision
  • memory loss
  • muscle pain
  • numbness or tingling of the hands, feet, or face
  • pain during sexual intercourse
  • sensation of spinning
  • stopping of menstrual bleeding
  • swelling of the breasts or breast soreness in both females and males
  • thick, white vaginal discharge with no odor or with a mild odor
  • unexpected or excess milk flow from the breasts

For Healthcare Professionals

Applies to octreotide: injectable solution, intramuscular powder for injection extended release, oral delayed release capsule, subcutaneous solution

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

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

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.