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

Applies to somatropin: powder for solution. Other dosage forms:

• powder for solution, solution

Serious side effects of Serostim

Along with its needed effects, somatropin (the active ingredient contained in Serostim) 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 somatropin:

More common

• Abnormal or decreased touch sensation
• bleeding after defecation
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color
• cold flu-like symptoms
• cold hands and feet
• confusion
• constipation
• cough or hoarseness
• darkened urine
• decreased urination
• diarrhea
• difficult urination
• dizziness
• dry mouth
• fainting or loss of consciousness
• fast heartbeat
• fast or irregular breathing
• feeling unusually cold
• fever or chills
• full or bloated feeling
• general feeling of discomfort or illness
• headache
• increase in heart rate
• itching or skin rash
• joint pain
• light-colored stools
• lightheadedness
• loss of appetite
• lower back or side pain
• muscle aching or cramping
• muscle pain or stiffness
• nausea
• pain
• pain, redness, or swelling in the arm or leg
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pressure in the stomach
• rapid, shallow breathing
• rapid weight gain
• rectal bleeding
• runny nose
• shivering
• sneezing
• sore mouth or tongue
• sore throat
• stomach bloating, burning, cramping, or pain
• sudden decrease in the amount of urine
• sweating
• swelling of the abdominal or stomach area
• swelling of the eyes or eyelids
• swelling or puffiness of the face
• swollen joints
• thirst
• tightness in the chest
• tingling of the hands or feet
• trouble breathing
• trouble sleeping
• uncomfortable swelling around the anus
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• vomiting of blood
• white patches in the mouth, tongue, or throat
• wrinkled skin
• yellow eyes or skin

Less common

• Bone or skeletal pain
• burning, numbness, pain, or tingling in all fingers except smallest finger
• chest pain
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• slowed heartbeat
• swelling of the ankles

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

Symptoms of overdose

• Anxiety
• blurred vision
• changes in vision
• cold sweats
• coma
• cool, pale skin
• decrease in the amount of urine
• depression
• excessive sweating
• extreme weakness
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• increase in hands and feet size
• increased hunger
• increased thirst
• increased urination
• increased volume of pale, diluted urine
• nightmares
• noisy, rattling breathing
• pain in the arms or legs
• seizures
• shakiness
• slurred speech
• stop in menstruation
• swelling of the fingers or hands
• troubled breathing at rest

Other side effects of Serostim

Some side effects of somatropin 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

• Body aches or pain
• breast pain
• change in the color, amount, or odor of vaginal discharge
• congestion
• discoloration of the fingernails or toenails
• dryness or soreness of the throat
• excess air or gas in the stomach or intestines
• frequent urge to defecate
• increased sweating
• passing gas
• sneezing
• straining while passing stool
• stuffy nose
• tender, swollen glands in neck
• trouble with swallowing
• voice changes

Less common

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• tiredness
• trouble concentrating

For Healthcare Professionals

Applies to somatropin: injectable kit, injectable powder for injection, subcutaneous kit, subcutaneous powder for injection, subcutaneous solution.

General

The most common adverse events were glucose intolerance, fluid retention, injection site reactions, and unmasking of latent central hypothyroidism.^[Ref]

Other

Very common (10% or more): Otitis media (up to 86.4%), surgical procedure (44.6%), peripheral edema (45.4%), edema (25%), flu syndrome (22.9%), ear disorders (17.6%), peripheral swelling (17.5%), leg edema (15%), pain in extremities (19.3%), pain (13.5%), headache (11.4%)

Common (1% to 10%): Hematoma, fatigue, flu-like symptoms, asthenia, fatigue, generalized edema

Uncommon (0.1% to 1%): Weakness

Frequency not reported: Sudden death, pyrexia, ear infection, influenza-like illness, otitis externa,

Postmarketing reports: Increased blood alkaline phosphatase level^[Ref]

Endocrine

Very common (10% or more): IGF-1 scores above 2 standard deviations (38%), hypothyroidism (16%)

Common (1% to 10%): Hypothyroidism

Uncommon (0.1% to 1%): Central precocious puberty

Frequency not reported: Unmasking of latent central hypothyroidism

Postmarketing reports: Decrease in serum thyroxin levels^[Ref]

Musculoskeletal

Scoliosis was reported as an adverse event in 5 out of 21 children with Noonan Syndrome who were followed for 11 years.^[Ref]

Very common (10% or more): Arthralgia (37.1%), myalgia (30.4%), scoliosis (23.8%), skeletal pain (11%), back pain (10.9%), arthrosis (10.7%)

Common (1% to 10%): Musculoskeletal stiffness, stiffness of extremities, joint stiffness, joint swelling, joint disorder, leg pain, hip pain, progression of preexisting scoliosis,

Uncommon (0.1% to 1%): Localized muscle pain, jaw prominence, slipped capital femoral epiphysis

Frequency not reported: fracture, joint pain, growth attenuation, interference with growth response, excessive growth of hands or feet, exacerbation of preexisting scoliosis, disproportionate growth of the lower jaw, fracture

Postmarketing reports: Legg-Calvé-Perthes disease^[Ref]

Metabolic

Very common (10% or more): Impaired fasting glucose (22%), elevated HbA1c (14%), blood glucose increased (13.8%)

Common (1% to 10%): Hyperglycemia, hyperlipidemia, glucose tolerance abnormal, fluid retention, hypertriglyceridemia, overt type II diabetes mellitus

Uncommon (0.1% to 1%): Diabetes mellitus, abnormalities of carbohydrate metabolism (glucose intolerance and high serum HbA1c)

Frequency not reported: Glucose intolerance including impaired glucose tolerance/impaired fasting glucose, increased appetite, transient episodes of fasting blood sugars between 100 and 126 mg/dL, transient episodes of fasting blood sugars exceeding 126 mg/dL, increased fasting blood glucose levels, increases in insulin levels, insulin resistance

Postmarketing reports: Exacerbation of preexisting diabetes mellitus, diabetic ketoacidosis, diabetic coma^[Ref]

Nervous system

Very common (10% or more): Paresthesia (17.3%), hypoesthesia (15%)

Common (1% to 10%): Hypesthesia, fatigue, carpal tunnel syndrome, Tinel's sign

Uncommon (0.1% to 1%): Benign intracranial hypertension, motor problem, seizure^[Ref]

Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients.^[Ref]

Gastrointestinal

Very common (10% or more): Pharyngitis (14.3%),

Common (1% to 10%): Nausea, gastroenteritis, gastritis

Frequency not reported: Abdominal pain, increased appetite

Postmarketing reports: Pancreatitis^[Ref]

Hepatic

Very common (10% or more): AST increased (12.5%)

Common (1% to 10%): ALT increased^[Ref]

Hematologic

Very common (10% or more): Eosinophilia (12%)^[Ref]

Ocular

Very common (10% or more): Periorbital edema

Frequency not reported: Diabetic retinopathy^[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (15.9%), rhinitis (13.5%)

Common (1% to 10%): Bronchitis, cough increased, laryngitis, respiratory disorder, dyspnea, sleep apnea

Frequency not reported: Influenza, tonsillitis, nasopharyngitis, sinusitis, bronchitis^[Ref]

Immunologic

An IgG antibody has been identified. No antibodies to the IgE class have been detected. Growth hormone antibody binding capacities less than 2 mg/L have not led to growth attenuation. Testing for antibodies should be carried out in any patient failing to respond to treatment.

Primate studies have failed to reveal evidence of histopathological changes due to immune complex formation.^[Ref]

Very common (10% or more): Anti-rhGH antibodies (24%), infection (non-viral) (13%)

Frequency not reported: Antibody formation, anti-periplasmic Escherichia coli peptides (PECP) antibodies^[Ref]

Local

Common (1% to 10%): Injection site pain

Frequency not reported: Injection site reactions/rashes, lipoatrophy, nodules, rash, inflammation, pigmentation, bleeding^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity to solvent (m-cresol/glycerol)

Rare (less than 0.1%): Generalized hypersensitivity reactions

Postmarketing reports: Hypersensitivity^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Cardiac disorders^[Ref]

Dermatologic

Common (1% to 10%): Increased sweating, excessive number of cutaneous nevi, acne

Uncommon (0.1% to 1%): Pruritus

Rare (less than 0.1%): Rash

Frequency not reported: Hair loss, progression of pigmented nevi, eczema^[Ref]

Genitourinary

Common (1% to 10%): Gynecomastia, breast-related adverse reactions (e.g. nipple pain,

gynecomastia, breast pain/mass/tenderness/swelling/edema/hypertrophy)

Frequency not reported: Urinary tract infection^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Aggressiveness, altered mood^[Ref]

Renal

Uncommon (0.1% to 1%): Glucosuria

Frequency not reported: Hematuria^[Ref]

Oncologic

Very rare (less than 0.01%): Leukemia

Frequency not reported: Intracranial tumors including meningiomas, melanocytic nevus^[Ref]