Humatrope (somatropin) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Somatropin

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 January 2004 to June 2026, FDA received 5,688 adverse event reports that name Humatrope. In these reports the drug is a suspect or interacting product.

In the same period, 244 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 43 reports in the 12 months to June 2026 and 75 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, 43 (under 0.1%) name Humatrope. Reports from consumers or other non-health professionals were 73.5% of the reports that name Humatrope and 45.8% 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 Humatrope 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 9 reports that name Humatrope.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 14.

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 278 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 all 5,688 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 278 terms.

Reaction terms in the reports that name Humatrope, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,688 reports
Incorrect dose administeredthe wrong dose was given	936	16.5%
Injection site painpain where the injection was given	410	7.2%
Drug dose omissiona dose was missed	397	7%
Underdoseless than the intended dose	384	6.8%
Fatiguetiredness	248	4.4%
Headachehead pain	223	3.9%
Malaisegeneral feeling of being unwell	219	3.9%
Wrong technique in product usage processthe product was used in the wrong way	218	3.8%
Injection site bruisingbruising where the injection was given	132	2.3%
Astheniaweakness or lack of energy	118	2.1%
Medication errora mistake in prescribing, dispensing or taking a medicine	108	1.9%
Weight increasedweight gain	100	1.8%
Pharmaceutical product complaint	99	1.7%
Feeling abnormalfeeling odd or not right	98	1.7%
Painpain, site not specified	95	1.7%
Nauseafeeling sick	92	1.6%
Arthralgiajoint pain	91	1.6%
Injection site haemorrhagebleeding where the injection was given	90	1.6%
Drug ineffectivethe medicine did not work as expected	89	1.6%
Vomitingbeing sick	86	1.5%
Off label useused for a purpose or in a way not on the label	85	1.5%
Pain in extremitypain in an arm or leg	75	1.3%
Nasopharyngitisa cold	70	1.2%
Pyrexiafever	70	1.2%
Falla fall	69	1.2%
Weight decreasedweight loss	68	1.2%
Dizzinesslight-headedness or unsteadiness	65	1.1%
Insomniadifficulty sleeping	65	1.1%
Anxiety	64	1.1%
Hospitalisationadmission to hospital	63	1.1%
Product dose omission issuea dose was missed	63	1.1%
Depressionlow mood	57	1%
Diarrhoealoose or frequent stools	55	1%
Product dose omissiona dose was missed	54	0.9%
Deaththe patient died; cause not stated by this term	52	0.9%
Accidental exposure to product	50	0.9%
Memory impairmentmemory problems	49	0.9%
Wrong dose	49	0.9%
Convulsion	48	0.8%
Rashskin rash	48	0.8%
Visual acuity reducedreduced sharpness of vision	47	0.8%
Pneumonialung infection	45	0.8%
Intentional device misuse	43	0.8%
Drug dispensing errora dispensing mistake	42	0.7%
Product preparation issuea problem preparing the product	41	0.7%
Crying	40	0.7%
Back pain	38	0.7%
Product storage errorthe product was stored wrongly	38	0.7%
Visual impairmentreduced vision	38	0.7%
Peripheral swellingswelling of the arms or legs	37	0.7%

Download all 278 terms of Humatrope (CSV)

The counts add to more than 5,688 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Somatropin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Somatropin	Generic name	5,518
Genotropin	Brand name	45,003
Humatrope (this page)	Brand name	5,688
Norditropin	Brand name	2,892
Omnitrope	Brand name	11,243
Serostim	Brand name	752
Zomacton	Brand name	281

Sum of the separately reported names: 71,377. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Humatrope, 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	107	104	11	10	61	2	1	46	3
2005	139	135	17	3	86	2	0	64	4
2006	132	125	5	4	71	0	0	74	7
2007	92	89	2	3	44	2	0	53	3
2008	161	152	12	8	78	3	0	72	9
2009	114	111	3	4	53	3	1	65	3
2010	96	91	6	1	39	2	0	59	5
2011	127	124	7	3	70	7	0	71	3
2012	158	152	9	1	69	3	0	88	6
2013	99	92	8	2	38	1	0	65	7
2014	97	39	4	0	15	0	0	26	58
2015	2,208	49	2	1	16	1	0	38	2,159
2016	214	40	5	3	13	4	0	25	174
2017	247	51	5	2	24	1	0	23	196
2018	374	66	8	2	27	0	0	40	308
2019	376	47	2	1	23	0	0	21	329
2020	355	50	3	2	17	2	1	30	305
2021	195	36	6	2	14	0	0	17	159
2022	93	21	3	0	9	0	0	9	72
2023	111	21	2	1	9	1	0	13	90
2024	115	22	5	0	7	0	0	11	93
2025	57	16	1	0	8	0	0	8	41
2026	21	6	1	1	3	0	0	4	15

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 Humatrope, 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 Humatrope, by the year in which FDA received them
Year	Reports
2004	99
2005	144
2006	125
2007	98
2008	145
2009	132
2010	107
2011	129
2012	170
2013	90
2014	101
2015	2,221
2016	200
2017	254
2018	373
2019	376
2020	358
2021	178
2022	89
2023	111
2024	113
2025	57
2026	18

Reports that name Humatrope, 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 Humatrope
Age	Reports	Share
Under 2	33	0.6%
2 to 11	599	10.5%
12 to 17	639	11.2%
18 to 44	234	4.1%
45 to 64	364	6.4%
65 to 74	143	2.5%
75 and over	105	1.8%
Age not given	3,571	62.8%

Sex of the patient in the reports that name Humatrope
Sex	Reports	Share
Female	2,492	43.8%
Male	2,911	51.2%
Unknown or not given	285	5%

Type of reporter in the reports that name Humatrope
Reporter	Reports	Share
Physician	730	12.8%
Pharmacist	236	4.1%
Other health professional	421	7.4%
Lawyer	0	0%
Consumer or non-health professional	4,180	73.5%
Not given	121	2.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 88.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Humatrope record
Indication as recorded (MedDRA)	Reports	Share
Growth hormone deficiency	1,081	19%
Hypopituitarism	485	8.5%
Body height below normal	176	3.1%
Growth retardation	95	1.7%
Hypothalamo-pituitary disorder	87	1.5%
Dwarfism	78	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,688 reports.

Drugs in the same reports

Other drugs that the reports of Humatrope name, in any role, in order of name
Drug	Reports that name the two
Androgel	39
Aspirin	42
Hydrocortisone	110
Levothyroxine	47
Levothyroxine sodium	48
Lipitor	28
Prednisone	51
Synthroid	209
Testosterone	77
Vitamin d	43

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

Somatropin same ingredient
Genotropin same ingredient
Norditropin same ingredient
Omnitrope same ingredient
Serostim same ingredient
Zomacton same ingredient
Humate-P next in the A to Z list
Humira next in the A to Z list
Human Normal Immunoglobulin Liquid 20 next in the A to Z list
Humira 40 Mg/0 8 Ml Pen next in the A to Z list
Human Normal Immunoglobulin Liquid next in the A to Z list
Humira 40 Mg/0 8 Ml Pre-Filled Syringe next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for HumatropeThe 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. Humatrope: adverse event reports that FDA received. https://reportedreactions.com/drug/humatrope/ 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 Humatrope as a suspect or interacting product. The 244 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 Humatrope 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 Humatrope?

No. It is a count of what people reported to FDA: 5,688 reports from January 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 (73.5%), physician (12.8%) and other health professional (7.4%). 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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