Saizen and Autism spectrum disorder - a phase IV clinical study of FDA data

Summary:

Autism spectrum disorder is reported as a side effect among people who take Saizen (somatropin recombinant), especially for people who are male, 10-19 old, have been taking the drug for 1 - 2 years also take Nutropin Aq, and have Growth hormone deficiency.

The phase IV clinical study analyzes which people have Autism spectrum disorder when taking Saizen. It is created by eHealthMe based on reports of 3,115 people who have side effects when taking Saizen from the FDA, and is updated regularly.

What is Saizen?

Saizen has active ingredients of somatropin recombinant. eHealthMe is studying from 3,122 Saizen users. Check the latest studies of Saizen.

What is Autism spectrum disorder?

Autism spectrum disorder (developmental disabilities that can cause significant social, communication and behavioural challenges) is found to be associated with 192 drugs and 112 conditions by eHealthMe. Check the latest studies of Autism spectrum disorder.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Aug, 31, 2026

3,115 people reported to have side effects when taking Saizen.
Among them, 14 people (0.45%) have Autism spectrum disorder.

Could Saizen cause Autism spectrum disorder?

Among these 14 people:

How long have people been on Saizen when they have Autism spectrum disorder? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 100 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Autism spectrum disorder when taking Saizen? *

  • female: 21.43 %
  • male: 78.57 %

What is the age of people who have Autism spectrum disorder when taking Saizen? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 100 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 0.0 %

What are other drugs people take besides Saizen? *

  1. Oxycodone: 3 people, 21.43%
  2. Nutropin Aq: 3 people, 21.43%

What are other side effects people have besides Autism spectrum disorder? *

  1. Skin Ulcer: 3 people, 21.43%
  2. Osgood-Schlatter Disease (an overuse injury that occurs in the knee area of growing adolescents. it is caused by inflammation of the tendon below the kneecap): 3 people, 21.43%
  3. Attention Deficit Hyperactivity Disorder (a chronic condition including attention difficulty, hyperactivity, and impulsiveness): 3 people, 21.43%
  4. Feeling Abnormal: 2 people, 14.29%
  5. The Flu (the flu is caused by an influenza virus): 1 person, 7.14%
  6. Stress And Anxiety: 1 person, 7.14%
  7. Photopsia (presence of perceived flashes of light): 1 person, 7.14%
  8. Nosebleed (bleeding from nose): 1 person, 7.14%
  9. Necrosis (the death of body tissue): 1 person, 7.14%
  10. Injection Site Haemorrhage (bleeding from injection site): 1 person, 7.14%

What are the existing conditions these people have? *

  1. Growth Hormone Deficiency: 6 people, 42.86%
  2. Wheezing (a high-pitched whistling sound made while you breath): 3 people, 21.43%
  3. Small For Dates Baby (an unborn baby is growing more slowly and is smaller than most babies are at the same age): 3 people, 21.43%
  4. Pain: 3 people, 21.43%
  5. Hypopituitarism (diminished hormone secretion by the pituitary gland, causing dwarfism in children and premature aging in adults): 3 people, 21.43%
  6. Cough: 3 people, 21.43%
  7. Body Height Below Normal: 3 people, 21.43%
  8. Primary Hypothyroidism (failure of the thyroid gland to produce or release thyroid hormones into the bloodstream): 2 people, 14.29%
  9. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 1 person, 7.14%
  10. Chronic Kidney Disease: 1 person, 7.14%

* Approximation only. Some reports may have incomplete information.

Do you take Saizen and have Autism spectrum disorder?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Saizen:

Autism spectrum disorder treatments and more:

How severe was Autism spectrum disorder and when was it recovered:

Expand to all the drugs that have ingredients of somatropin recombinant:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Saizen:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Autism spectrum disorder:

Browse all the conditions that are associated with Autism spectrum disorder:


How the study uses the data?

The study uses data from the FDA. It is based on somatropin recombinant (the active ingredients of Saizen) and Saizen (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.



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