Octreotide acetate adverse event reports that FDA received

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

Name type: Generic name
Class: Somatostatin analog
Also reported as: Octreotide Acetate Injection

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 1,227 adverse event reports that name Octreotide acetate. In these reports the drug is a suspect or interacting product.

In the same period, 836 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 120 reports in the 12 months to June 2026 and 89 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, 120 (under 0.1%) name Octreotide acetate. Reports from consumers or other non-health professionals were 17.5% of the reports that name Octreotide acetate 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 Octreotide acetate 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 38 reports that name Octreotide acetate.
In January to March 2026, FDA received 37.
In April to June 2025, FDA received 21.

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 277 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 1,153 of the 1,227 reports (94%).

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 277 terms.

Reaction terms in the reports that name Octreotide acetate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,227 reports
Diarrhoealoose or frequent stools	134	10.9%
Product use in unapproved indicationused for a purpose not on the label	128	10.4%
Off label useused for a purpose or in a way not on the label	106	8.6%
Fatiguetiredness	105	8.6%
Inappropriate schedule of product administrationthe product was taken at the wrong times	105	8.6%
Abdominal painstomach or belly pain	104	8.5%
Deaththe patient died; cause not stated by this term	100	8.1%
Injection site painpain where the injection was given	93	7.6%
Nauseafeeling sick	93	7.6%
Malignant neoplasm progression	90	7.3%
Blood pressure increaseda raised blood pressure reading	88	7.2%
Malaisegeneral feeling of being unwell	74	6%
Astheniaweakness or lack of energy	67	5.5%
Headachehead pain	67	5.5%
Painpain, site not specified	67	5.5%
Blood pressure systolic increased	62	5.1%
Cough	61	5%
Drug ineffectivethe medicine did not work as expected	61	5%
Dyspnoeashortness of breath	59	4.8%
Dizzinesslight-headedness or unsteadiness	58	4.7%
Needle issuea problem with the needle	58	4.7%
Back pain	52	4.2%
Falla fall	51	4.2%
Vomitingbeing sick	51	4.2%
Weight decreasedweight loss	48	3.9%
Arthralgiajoint pain	47	3.8%
Hypotensionlow blood pressure	46	3.7%
Pain in extremitypain in an arm or leg	46	3.7%
Pyrexiafever	46	3.7%
Abdominal distensiona bloated abdomen	44	3.6%
Contusiona bruise	44	3.6%
Heart rate decreased	40	3.3%
Hypoglycaemialow blood sugar	37	3%
Flushingsudden reddening or warmth of the skin	33	2.7%
Cholelithiasisgallstones	32	2.6%
Metastases to liver	32	2.6%
Gait disturbancedifficulty walking	31	2.5%
Loss of consciousnesspassing out	31	2.5%
Nasopharyngitisa cold	31	2.5%
Abdominal pain upperupper stomach pain	30	2.4%
Haemoglobin decreasedlow haemoglobin	29	2.4%
Hyperhidrosisexcessive sweating	28	2.3%
Neoplasm progression	28	2.3%
Body temperature decreased	27	2.2%
Pneumonialung infection	27	2.2%
Syncopefainting	27	2.2%
Constipation	26	2.1%
Decreased appetitereduced appetite	26	2.1%
General physical health deteriorationgeneral decline in health	26	2.1%
Heart rate increaseda fast heart rate reading	26	2.1%

Download all 277 terms of Octreotide acetate (CSV)

The counts add to more than 1,227 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 Octreotide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Octreotide	Generic name	3,372
Octreotide acetate (this page)	Generic name	1,227
Mycapssa	Brand name	279
Sandostatin	Brand name	5,413
Sandostatin LAR Depot	Brand name	16,955

Sum of the separately reported names: 27,246. 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 Octreotide acetate, 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	Other Serious (Important Medical Events)	Not serious
2004	8	7	6	0	1	0	1	1
2005	13	12	2	0	6	0	5	1
2006	14	9	1	0	4	0	4	5
2007	26	23	5	1	9	0	17	3
2008	31	30	3	3	12	0	22	1
2009	31	27	6	1	11	1	19	4
2010	41	40	7	3	14	1	26	1
2011	51	48	14	1	13	0	33	3
2012	39	35	11	2	14	0	18	4
2013	14	12	0	3	7	0	6	2
2014	8	8	2	2	3	0	4	0
2015	11	8	2	1	4	0	4	3
2016	26	16	1	1	8	0	9	10
2017	14	7	0	0	2	0	5	7
2018	28	18	4	1	9	0	12	10
2019	47	32	3	0	11	0	29	15
2020	44	40	7	0	11	1	32	4
2021	102	88	12	3	36	1	57	14
2022	177	167	34	8	79	1	84	10
2023	168	159	29	5	59	2	97	9
2024	144	141	20	13	69	2	94	3
2025	99	91	13	13	43	0	62	8
2026	91	73	3	1	50	0	47	18

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 Octreotide acetate, 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 Octreotide acetate, by the year in which FDA received them
Year	Reports
2004	6
2005	14
2006	12
2007	26
2008	27
2009	35
2010	43
2011	51
2012	44
2013	16
2014	5
2015	12
2016	28
2017	14
2018	36
2019	62
2020	55
2021	113
2022	174
2023	170
2024	124
2025	85
2026	75

Reports that name Octreotide acetate, 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 Octreotide acetate
Age	Reports	Share
Under 2	34	2.8%
2 to 11	20	1.6%
12 to 17	11	0.9%
18 to 44	104	8.5%
45 to 64	329	26.8%
65 to 74	202	16.5%
75 and over	154	12.6%
Age not given	373	30.4%

Sex of the patient in the reports that name Octreotide acetate
Sex	Reports	Share
Female	605	49.3%
Male	495	40.3%
Unknown or not given	127	10.4%

Type of reporter in the reports that name Octreotide acetate
Reporter	Reports	Share
Physician	246	20%
Pharmacist	132	10.8%
Other health professional	573	46.7%
Lawyer	0	0%
Consumer or non-health professional	215	17.5%
Not given	61	5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 30.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Octreotide acetate record
Indication as recorded (MedDRA)	Reports	Share
Neuroendocrine tumour	116	9.5%
Acromegaly	86	7%
Carcinoid tumour	38	3.1%
Angiodysplasia	30	2.4%
Diarrhoea	30	2.4%
Pancreatic neuroendocrine tumour	28	2.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,227 reports.

Drugs in the same reports

Other drugs that the reports of Octreotide acetate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	37
Afinitor	51
Amlodipine	26
Aspirin	38
Everolimus	30
Furosemide	33
Metformin	25
Pantoprazole	46
Sandostatin	95
Sandostatin LAR Depot	22

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

Octreotide same ingredient
Mycapssa same ingredient
Sandostatin same ingredient
Sandostatin LAR Depot same ingredient
Pasireotide same class
Lanreotide acetate same class
Signifor same class
Odactra next in the A to Z list
Octagam Immune Globulin (Human) next in the A to Z list
Odefsey next in the A to Z list
Octagam next in the A to Z list
Odomzo next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Octreotide acetateThe 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. Octreotide acetate: adverse event reports that FDA received. https://reportedreactions.com/drug/octreotide-acetate/ 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 Octreotide acetate as a suspect or interacting product. The 836 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 Octreotide acetate 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 Octreotide acetate?

No. It is a count of what people reported to FDA: 1,227 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?

Other health professional (46.7%), physician (20%) and consumer or non-health professional (17.5%). 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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