Serostim Side Effects

Generic name: somatropin

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Note: This document provides detailed information about Serostim Side Effects associated with somatropin. Some dosage forms listed on this page may not apply specifically to the brand name Serostim.

Applies to somatropin: powder for solution.

Other dosage forms:

• powder for solution, solution

Precautions

It is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

This medicine may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.

Pancreatitis (an inflamed pancreas) may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pains in stomach, side, or abdomen possibly radiating to the back, vomiting, or yellow eyes or skin.

This medicine may affect blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions.

This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause fluid retention (extra water in the body). Tell your doctor if you or your child have burning, numbness, pain, or tingling in all fingers except smallest finger, swelling of the hands and feet, or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.

This medicine is usually mixed with Bacteriostatic Water for Injection. You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix this medicine.

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:

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:

For healthcare professionals

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

General adverse events

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

• 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]

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

• 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]

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]

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,
• Frequency not reported: Urinary tract infection^[Ref]

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

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]

See also:

Further information

Serostim side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer