Saizen adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Saizen
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 2,796 adverse event reports that name Saizen. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 65 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 194 reports in the 12 months to June 2026 and 170 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 194 (under 0.1%) name Saizen. Reports for patients aged 2 to 11 were 25.8% of the reports that name Saizen and 1.4% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Saizen is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 44 reports that name Saizen.
In January to March 2026, FDA received 48.
In April to June 2025, FDA received 38.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 145 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,787 of the 2,796 reports (99.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 145 terms.

Reaction terms in the reports that name Saizen, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,796 reports
Off label useused for a purpose or in a way not on the label	181	6.5%
Headachehead pain	143	5.1%
Deaththe patient died; cause not stated by this term	113	4%
Vomitingbeing sick	112	4%
Pyrexiafever	82	2.9%
Pneumonialung infection	63	2.3%
Seizurea fit or convulsion	62	2.2%
Syncopefainting	58	2.1%
Diabetes mellitusdiabetes	54	1.9%
Brain neoplasm	52	1.9%
Malaisegeneral feeling of being unwell	51	1.8%
Fatiguetiredness	47	1.7%
Intracranial pressure increased	47	1.7%
Scoliosis	47	1.7%
Injection site painpain where the injection was given	40	1.4%
Epilepsy	39	1.4%
Arthralgiajoint pain	38	1.4%
Dizzinesslight-headedness or unsteadiness	38	1.4%
Craniopharyngioma	36	1.3%
Falla fall	34	1.2%
Nauseafeeling sick	34	1.2%
Convulsion	33	1.2%
Treatment noncompliancethe treatment was not taken as directed	33	1.2%
Drug dose omissiona dose was missed	30	1.1%
Pain in extremitypain in an arm or leg	29	1%
Papilloedema	29	1%
Diarrhoealoose or frequent stools	26	0.9%
Weight decreasedweight loss	26	0.9%
Product dose omission issuea dose was missed	25	0.9%
Astheniaweakness or lack of energy	24	0.9%
Decreased appetitereduced appetite	23	0.8%
Hypertensionhigh blood pressure	23	0.8%
Gastrointestinal disorder	22	0.8%
Influenzaflu	22	0.8%
Urinary tract infectionbladder or urinary infection	22	0.8%
Dehydration	21	0.8%
Infectionan infection, type not specified	21	0.8%
Blood glucose increasedraised blood sugar reading	20	0.7%
Neoplasm	20	0.7%
Renal disorder	20	0.7%
Epiphyses premature fusion	19	0.7%
Abdominal pain upperupper stomach pain	18	0.6%
Condition aggravatedthe condition being treated got worse	18	0.6%
Lower respiratory tract infectiona chest infection	18	0.6%
Renal transplant	18	0.6%
Viral infectiona viral infection	18	0.6%
Cerebrovascular accidentstroke	17	0.6%
Pituitary tumour	17	0.6%
Depressionlow mood	16	0.6%
Drug ineffectivethe medicine did not work as expected	16	0.6%

Download all 145 terms of Saizen (CSV)

The counts add to more than 2,796 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Saizen, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	9	9	1	0	3	1	0	5	0
2005	21	20	1	0	11	0	0	11	1
2006	18	18	1	3	9	1	0	8	0
2007	25	25	4	0	12	1	0	10	0
2008	35	33	4	2	17	1	0	15	2
2009	60	59	6	1	36	0	0	27	1
2010	98	89	10	4	50	3	0	38	9
2011	156	152	9	3	66	4	1	85	4
2012	139	137	1	4	60	3	0	82	2
2013	194	192	19	1	53	3	0	129	2
2014	176	166	11	3	77	5	0	89	10
2015	154	138	15	7	56	1	1	76	16
2016	165	147	15	3	49	2	3	93	18
2017	167	152	9	0	51	3	0	98	15
2018	171	165	12	1	58	5	0	100	6
2019	162	154	11	4	43	2	0	104	8
2020	125	121	13	7	38	1	0	82	4
2021	133	131	11	4	51	2	0	77	2
2022	133	130	14	2	42	0	0	80	3
2023	198	196	19	2	74	4	0	117	2
2024	166	164	9	5	69	3	0	95	2
2025	188	185	4	3	75	2	0	121	3
2026	103	102	5	1	37	0	0	66	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Saizen, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Saizen, by the year in which FDA received them
Year	Reports
2004	9
2005	20
2006	19
2007	24
2008	36
2009	56
2010	101
2011	159
2012	152
2013	213
2014	145
2015	168
2016	163
2017	178
2018	171
2019	157
2020	130
2021	121
2022	133
2023	202
2024	161
2025	186
2026	92

Reports that name Saizen, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Saizen
Age	Reports	Share
Under 2	30	1.1%
2 to 11	720	25.8%
12 to 17	620	22.2%
18 to 44	130	4.6%
45 to 64	67	2.4%
65 to 74	24	0.9%
75 and over	19	0.7%
Age not given	1,186	42.4%

Sex of the patient in the reports that name Saizen
Sex	Reports	Share
Female	1,225	43.8%
Male	1,510	54%
Unknown or not given	61	2.2%

Type of reporter in the reports that name Saizen
Reporter	Reports	Share
Physician	564	20.2%
Pharmacist	48	1.7%
Other health professional	223	8%
Lawyer	1	under 0.1%
Consumer or non-health professional	1,828	65.4%
Not given	132	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Saizen record
Indication as recorded (MedDRA)	Reports	Share
Growth hormone deficiency	1,224	43.8%
Body height below normal	92	3.3%
Small for dates baby	87	3.1%
Growth retardation	79	2.8%
Hypopituitarism	69	2.5%
Turner's syndrome	40	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,796 reports.

Drugs in the same reports

Other drugs that the reports of Saizen name, in any role, in order of name
Drug	Reports that name the two
Desmopressin	21
Ergocalciferol	13
Euthyrox	25
Hydrocortisone	90
Levothyroxine	54
Levothyroxine sodium	47
Prednisolone	24
Synthroid	44
Testosterone	15
Vitamin d	13

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Safyral next in the A to Z list
Saizen for Injection next in the A to Z list
Sacubitril valsartan next in the A to Z list
Sajazir next in the A to Z list
Sacubitril next in the A to Z list
Salazopyrin next in the A to Z list
Sacituzumab Govitecan-Hziy next in the A to Z list
Salazopyrine next in the A to Z list
Sacituzumab govitecan next in the A to Z list
Salbutamol next in the A to Z list
Sabril next in the A to Z list
Salbutamol sulfate next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for SaizenThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Saizen: adverse event reports that FDA received. https://reportedreactions.com/drug/saizen/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Saizen as a suspect or interacting product. The 65 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Saizen was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Saizen?

No. It is a count of what people reported to FDA: 2,796 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (65.4%), physician (20.2%) and other health professional (8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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