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

Summary

Common side effects of Sandostatin include: cardiac conduction disorder, gallbladder sludge, and hyperglycemia. Other side effects include: cardiac arrhythmia, and hypoglycemia. Continue reading for a comprehensive list of adverse effects.

Applies to octreotide: oral capsule delayed release. Other dosage forms:

• powder for suspension, solution

Serious side effects of Sandostatin

Along with its needed effects, octreotide (the active ingredient contained in Sandostatin) 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

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chest tightness
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• dry mouth
• fever
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• gaseous stomach pain
• general feeling of discomfort or illness
• headache
• increased hunger
• increased thirst
• increased urination
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches or pains
• nausea
• pain or tenderness around the eyes and cheekbones
• recurrent fever
• shivering
• sore throat
• stomach pain or fullness
• stuffy or runny nose
• sweating
• swelling of the hands, ankles, feet, or lower legs
• trouble breathing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common

• Anxiety
• body aches or pain
• burning feeling in the chest or stomach
• cold sweats
• confusion
• constipation
• cool, pale skin
• depressed mood
• dizziness
• dry skin and hair
• ear congestion
• fainting
• fast, slow, or irregular heartbeat
• hair loss
• hoarseness or husky voice
• indigestion
• loss of consciousness
• loss of voice
• muscle cramps or stiffness
• nervousness
• nightmares
• pounding in the ears
• seizures
• shakiness
• slurred speech
• sneezing
• stomach upset or tenderness
• weight gain

Incidence not known

• Black, tarry stools
• bleeding gums
• blindness
• bloating
• blood in vomit
• change in the frequency or amount of urine
• changes in vision
• chest pain or discomfort
• dark urine
• darkening of the skin
• deafness
• decreased vision
• dizziness, fainting, or lightheadedness when getting up suddenly from lying or sitting position
• double vision
• eye pain
• hives, skin rash
• itching, pain, redness, swelling, tenderness, or warmth of the skin
• light-colored stools
• loss of appetite
• migraine headache
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• paleness or cold feeling in the fingertips and toes
• pinpoint red spots on the skin
• problems with speech or speaking
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe cramping
• sores, ulcers, or white spots on the lips or in the mouth
• tearing
• tingling or pain in the fingers or toes when exposed to cold temperature
• unusual bleeding or bruising
• vomiting of blood or material that looks like coffee grounds
• weakness of the muscles in your face

Other side effects of Sandostatin

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

• Difficulty in moving
• joint swelling or redness
• lack or loss of strength
• passing gas
• pressure in the stomach
• swelling of the abdominal or stomach area

Less common

• Bleeding after defecation
• uncomfortable swelling around the anus

Incidence not known

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from 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 (the active ingredient contained in Sandostatin) (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]