If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
This is a report of a 9-year-old female patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: growth hormone deficiency, who was treated with Somatropin)) (somatropin) (dosage: Sc, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Benign Intracranial Hypertension, Metabolic Acidosis, Papilloedema, Strabismus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Somatropin)) (somatropin) treatment in female patients, resulting in Benign Intracranial Hypertension side effect. The patient was hospitalized.
The appearance of Somatropin)) on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
What are common Somatropin)) Side Effects for Women?
What are common Somatropin)) Side Effects for Men?
Men Side Effects
Track Your Side Effects
Note Your Observations
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Somatropin)) reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.