Erlotinib adverse event reports that FDA received

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

Name type: Generic name
Class: Kinase inhibitor
Also reported as: Erlotinib Tablet 150mg, Erlotinib Tablet, Erlotinib Tablet 100mg

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 May 2004 to June 2026, FDA received 13,630 adverse event reports that name Erlotinib. In these reports the drug is a suspect or interacting product.

In the same period, 463 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 99 reports in the 12 months to June 2026 and 254 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, 99 (under 0.1%) name Erlotinib. Reports for female patients were 42.3% of the reports that name Erlotinib and 52.7% 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 Erlotinib 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 32 reports that name Erlotinib.
In January to March 2026, FDA received 30.
In April to June 2025, FDA received 42.

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 698 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 13,499 of the 13,630 reports (99%).

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 698 terms.

Reaction terms in the reports that name Erlotinib, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 13,630 reports
Deaththe patient died; cause not stated by this term	4,286	31.4%
Rashskin rash	1,465	10.7%
Diarrhoealoose or frequent stools	1,396	10.2%
Malignant neoplasm progression	1,281	9.4%
Off label useused for a purpose or in a way not on the label	928	6.8%
Fatiguetiredness	736	5.4%
Nauseafeeling sick	724	5.3%
Vomitingbeing sick	586	4.3%
Dyspnoeashortness of breath	562	4.1%
Disease progressionthe disease advanced	542	4%
Astheniaweakness or lack of energy	515	3.8%
Decreased appetitereduced appetite	513	3.8%
Anaemialow red blood cells	487	3.6%
Pneumonialung infection	453	3.3%
Drug resistance	439	3.2%
Dehydration	404	3%
Malaisegeneral feeling of being unwell	387	2.8%
Pyrexiafever	361	2.6%
Drug ineffectivethe medicine did not work as expected	349	2.6%
Painpain, site not specified	346	2.5%
Pleural effusionfluid around the lung	317	2.3%
Weight decreasedweight loss	298	2.2%
Abdominal painstomach or belly pain	291	2.1%
Incorrect dose administeredthe wrong dose was given	287	2.1%
Cough	281	2.1%
Neutropenialow neutrophils, a type of white blood cell	266	2%
Pulmonary embolisma blood clot in the lung	266	2%
Hypertensionhigh blood pressure	261	1.9%
Respiratory failurethe lungs could not supply enough oxygen	257	1.9%
Dermatitis acneiform	243	1.8%
Constipation	238	1.7%
Dry skin	227	1.7%
Thrombocytopenialow platelets	217	1.6%
Falla fall	215	1.6%
General physical health deteriorationgeneral decline in health	209	1.5%
Pruritusitching	198	1.5%
Dizzinesslight-headedness or unsteadiness	180	1.3%
Alopeciahair loss	174	1.3%
Haemoglobin decreasedlow haemoglobin	166	1.2%
Headachehead pain	163	1.2%
Lung neoplasm malignantlung cancer	155	1.1%
Stomatitissore mouth	153	1.1%
Infectionan infection, type not specified	145	1.1%
Haemoptysiscoughing up blood	144	1.1%
Interstitial lung diseasescarring or inflammation of lung tissue	144	1.1%
Back pain	143	1%
Acne	142	1%
Paronychia	141	1%
Confusional stateconfusion	135	1%
Hyponatraemialow blood sodium	135	1%

Download all 698 terms of Erlotinib (CSV)

The counts add to more than 13,630 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 Erlotinib with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Erlotinib (this page)	Generic name	13,630
Erlotinib hydrochloride	Generic name	2,691

Sum of the separately reported names: 16,321. 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 Erlotinib, 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	14	11	0	0	10	0	0	1	3
2005	58	56	10	2	38	0	0	12	2
2006	158	155	43	14	127	5	0	15	3
2007	305	304	108	18	229	5	0	17	1
2008	467	466	150	23	340	14	0	53	1
2009	483	481	170	36	328	8	0	83	2
2010	329	326	104	24	231	6	1	63	3
2011	100	100	34	10	63	3	0	23	0
2012	751	747	512	4	189	3	0	195	4
2013	2,039	2,028	1,381	24	533	14	0	642	11
2014	1,643	1,639	1,047	23	467	9	0	930	4
2015	2,510	2,507	2,012	26	425	7	0	835	3
2016	935	931	398	28	314	8	0	511	4
2017	680	659	221	27	202	4	0	372	21
2018	721	716	170	21	190	7	1	487	5
2019	471	410	79	8	95	6	0	324	61
2020	419	380	69	6	114	3	0	303	39
2021	434	398	50	8	80	2	0	346	36
2022	392	365	58	2	86	1	0	294	27
2023	245	213	56	3	44	0	0	162	32
2024	260	244	49	12	79	1	0	201	16
2025	135	125	32	6	30	0	0	101	10
2026	81	76	6	4	13	0	0	67	5

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 Erlotinib, 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 Erlotinib, by the year in which FDA received them
Year	Reports
2004	8
2005	62
2006	149
2007	306
2008	464
2009	499
2010	307
2011	182
2012	1,162
2013	2,217
2014	1,713
2015	2,112
2016	791
2017	702
2018	676
2019	449
2020	382
2021	418
2022	368
2023	230
2024	245
2025	126
2026	62

Reports that name Erlotinib, 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 Erlotinib
Age	Reports	Share
Under 2	3	under 0.1%
2 to 11	25	0.2%
12 to 17	16	0.1%
18 to 44	405	3%
45 to 64	3,073	22.5%
65 to 74	2,575	18.9%
75 and over	1,979	14.5%
Age not given	5,554	40.7%

Sex of the patient in the reports that name Erlotinib
Sex	Reports	Share
Female	5,767	42.3%
Male	6,026	44.2%
Unknown or not given	1,837	13.5%

Type of reporter in the reports that name Erlotinib
Reporter	Reports	Share
Physician	3,027	22.2%
Pharmacist	365	2.7%
Other health professional	2,938	21.6%
Lawyer	0	0%
Consumer or non-health professional	6,941	50.9%
Not given	359	2.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 53.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Erlotinib record
Indication as recorded (MedDRA)	Reports	Share
Non-small cell lung cancer	3,771	27.7%
Lung neoplasm malignant	1,801	13.2%
Pancreatic carcinoma	881	6.5%
Lung adenocarcinoma	665	4.9%
Malignant respiratory tract neoplasm	544	4%
Lung carcinoma cell type unspecified stage 0	287	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 13,630 reports.

Drugs in the same reports

Other drugs that the reports of Erlotinib name, in any role, in order of name
Drug	Reports that name the two
Aspirin	242
Avastin	646
Bevacizumab	1,330
Carboplatin	841
Cisplatin	410
Docetaxel	229
Gemcitabine	730
Osimertinib	248
Paclitaxel	447
Pemetrexed	449

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

Erlotinib hydrochloride same ingredient
Erdafitinib same class
Dasatinib same class
Everolimus same class
Dabrafenib same class
Fotivda same class
Erleada next in the A to Z list
Erivedge next in the A to Z list
Ertapenem next in the A to Z list
Eribulin mesylate next in the A to Z list
Ertapenem sodium next in the A to Z list
Eribulin 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 ErlotinibThe 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. Erlotinib: adverse event reports that FDA received. https://reportedreactions.com/drug/erlotinib/ 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 Erlotinib as a suspect or interacting product. The 463 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 Erlotinib 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 Erlotinib?

No. It is a count of what people reported to FDA: 13,630 reports from May 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 (50.9%), physician (22.2%) and other health professional (21.6%). 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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