Note: This document contains side effect information about octreotide. Some dosage forms listed on this page may not apply to the brand name Bynfezia Pen.
Applies to octreotide: oral capsule delayed release. Other dosage forms:
- powder for suspension, solution
Serious side effects of Bynfezia Pen
Along with its needed effects, octreotide (the active ingredient contained in Bynfezia Pen) 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 Bynfezia Pen
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 Bynfezia Pen) (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]
