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Saizen Side Effects

Generic Name: somatropin

Note: This page contains side effects data for the generic drug somatropin. It is possible that some of the dosage forms included below may not apply to the brand name Saizen.

It is possible that some side effects of Saizen may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to somatropin: powder for solution

As well as its needed effects, somatropin (the active ingredient contained in Saizen) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking somatropin, check with your doctor immediately:

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
  • 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
  • skin rash
  • 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 and/or wheezing
  • tingling of the hands or feet
  • trouble with breathing
  • trouble with 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

If any of the following symptoms of overdose occur while taking somatropin, get emergency help immediately:

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
  • shortness of breath
  • slurred speech
  • stop in menstruation
  • swelling of the fingers or hands
  • troubled breathing at rest

Some somatropin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • rash
  • 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
  • sleeplessness
  • tiredness
  • trouble concentrating
  • unable to sleep

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

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

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]

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,
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]

References

1. "Product Information. Nutropin (somatropin)." Genentech, South San Francisco, CA.

2. "Product Information. Humatrope (somatropin)." Lilly, Eli and Company, Indianapolis, IN.

3. "Product Information. Zorbtive (somatropin)." Serono Laboratories Inc, Rockland, MA.

4. "Product Information. Serostim (somatropin)." Serono Laboratories Inc, Rockland, MA.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. "Product Information. Genotropin (somatropin)." Pharmacia and Upjohn, Kalamazoo, MI.

7. "Product Information. Norditropin Cartridge (somatropin)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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