Norditropin FlexPro Side Effects
Generic name: somatropin
Medically reviewed by Drugs.com. Last updated on Nov 1, 2023.
Note: This document contains side effect information about somatropin. Some dosage forms listed on this page may not apply to the brand name Norditropin FlexPro.
Applies to somatropin: powder for solution, solution. Other dosage forms:
Serious side effects of Norditropin FlexPro
Along with its needed effects, somatropin (the active ingredient contained in Norditropin FlexPro) 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
- Bleeding gums
- bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
- burning, numbness, pain, or tingling in all fingers except the smallest finger
- coughing up blood
- difficulty with breathing or swallowing
- difficulty with moving
- dizziness
- increased menstrual flow or vaginal bleeding
- muscle pain or stiffness
- nosebleeds
- not able to move
- pain, swelling, or redness in the joints
- prolonged bleeding from cuts
- rapid weight gain
- red or black, tarry stools
- red or dark brown urine
- tingling of the hands or feet
- unusual weight gain or loss
Rare
- 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
- blurred vision
- bone pain
- change in personality
- change in the ability to see colors, especially blue or yellow
- changes in vision
- chills
- confusion
- constipation
- curved spine
- darkened urine
- dry mouth
- fast heartbeat
- fever
- flushed, dry skin
- fracture
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- indigestion
- limp pain in the hip or knee
- loss of appetite
- loss of consciousness
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- problems with walking or talking
- seizures
- stomachache
- sweating
- tumor
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Incidence not known
- Cough
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin lesions
- tightness in the chest
- unexplained weight loss
Get emergency help immediately if any of the following symptoms of overdose occur while taking somatropin:
Symptoms of overdose
- Backache
- excessive sweating
- extreme weakness
- increase in hand and foot size
- increased volume of pale, diluted urine
- pain in the arms or legs
- stop in menstruation
Other side effects of Norditropin FlexPro
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
- Large, flat, blue, or purplish patches in the skin
- unusually warm skin
Rare
- Swelling of the breasts or breast soreness in both females and males
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
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]
More about Norditropin FlexPro (somatropin)
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References
1. Product Information. Nutropin (somatropin). Genentech. 2001;PROD.
2. Product Information. Genotropin (somatropin). Pharmacia and Upjohn. 2003.
3. Product Information. Humatrope (somatropin). Lilly, Eli and Company. 2003.
4. Product Information. Serostim (somatropin). Serono Laboratories Inc. 2004.
5. Product Information. Norditropin Cartridge (somatropin). Novo Nordisk Pharmaceuticals Inc. 2004.
6. Product Information. Zorbtive (somatropin). Serono Laboratories Inc. 2004.
7. Cerner Multum, Inc. UK Summary of Product Characteristics.
8. Cerner Multum, Inc. Australian Product Information.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.