Nortriptyline hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Tricyclic antidepressant

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 September 2004 to June 2026, FDA received 1,702 adverse event reports that name Nortriptyline hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 1,732 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 225 reports in the 12 months to June 2026 and 258 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, 225 (under 0.1%) name Nortriptyline hydrochloride. Reports from other health professionals were 56.1% of the reports that name Nortriptyline hydrochloride and 19.7% 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 Nortriptyline hydrochloride 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 72 reports that name Nortriptyline hydrochloride.
In January to March 2026, FDA received 53.
In April to June 2025, FDA received 39.

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 226 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 1,675 of the 1,702 reports (98.4%).

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 226 terms.

Reaction terms in the reports that name Nortriptyline hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,702 reports
Off label useused for a purpose or in a way not on the label	557	32.7%
Hyperhidrosisexcessive sweating	479	28.1%
Drug ineffectivethe medicine did not work as expected	462	27.1%
Headachehead pain	374	22%
Painpain, site not specified	363	21.3%
Hypersensitivityan allergic-type reaction	361	21.2%
Exposure during pregnancythe medicine was taken during pregnancy	337	19.8%
Hepatic enzyme increasedraised liver enzymes	337	19.8%
Immunodeficiency	334	19.6%
Food allergy	332	19.5%
Overdosea dose above the recommended amount	323	19%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	313	18.4%
Product use issuea problem in how the product was used	308	18.1%
Prescribed overdose	301	17.7%
Upper respiratory tract infectiona cold or similar infection	297	17.5%
Joint swellinga swollen joint	296	17.4%
Rash erythematousa red rash	290	17%
Asthma	288	16.9%
Hypertensionhigh blood pressure	286	16.8%
Fatiguetiredness	282	16.6%
Intentional product misusedeliberate use not as intended	277	16.3%
Constipation	276	16.2%
Drug intolerancethe medicine was not tolerated	275	16.2%
Infusion related reactiona reaction during or soon after an infusion	274	16.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	260	15.3%
Contraindicated product administered	256	15%
Fluid retentionthe body holding extra fluid	256	15%
Pyrexiafever	255	15%
Temperature regulation disorder	253	14.9%
Rashskin rash	250	14.7%
Thrombocytopenialow platelets	244	14.3%
Back pain	232	13.6%
Coeliac disease	224	13.2%
Bursitis	222	13%
Somnolencedrowsiness	221	13%
Treatment failurethe treatment did not work	221	13%
Erythemaskin redness	218	12.8%
Nauseafeeling sick	218	12.8%
Psoriasispsoriasis, a skin condition	205	12%
Product use in unapproved indicationused for a purpose not on the label	204	12%
Coma	195	11.5%
Gastrooesophageal reflux diseaseacid reflux	195	11.5%
Pneumonia aspirationlung infection from breathing in material	195	11.5%
Foetal death	182	10.7%
Infectionan infection, type not specified	181	10.6%
Sedationdrowsiness	147	8.6%
Toxicity to various agentspoisoning or toxic effect of one or more substances	147	8.6%
Nightmarenightmares	142	8.3%
Nephrolithiasiskidney stones	112	6.6%
Hypotensionlow blood pressure	75	4.4%

Download all 226 terms of Nortriptyline hydrochloride (CSV)

The counts add to more than 1,702 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 Nortriptyline hydrochloride with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Nortriptyline hydrochloride (this page)	Generic name	1,702
Pamelor	Brand name	678

Sum of the separately reported names: 2,380. 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 Nortriptyline hydrochloride, 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	1	1	0	0	0	0	0	1	0
2005	1	1	1	0	0	0	0	0	0
2007	4	4	4	0	0	0	0	0	0
2008	5	5	2	0	3	0	0	0	0
2009	6	5	0	0	5	0	2	2	1
2010	17	17	11	0	3	1	0	4	0
2011	29	29	23	1	4	1	1	7	0
2012	17	17	7	2	8	1	0	7	0
2013	10	9	5	0	8	3	0	3	1
2014	13	13	1	0	4	0	0	9	0
2015	22	21	11	1	3	2	0	8	1
2016	36	17	5	0	5	1	0	10	19
2017	37	19	7	0	14	0	0	5	18
2018	58	32	5	2	22	0	0	20	26
2019	131	105	9	3	83	3	0	80	26
2020	141	104	28	0	45	2	0	74	37
2021	136	103	7	0	36	0	1	93	33
2022	128	98	3	1	38	2	1	87	30
2023	184	155	19	0	24	1	2	148	29
2024	260	242	44	6	18	5	0	224	18
2025	249	228	60	6	14	5	2	218	21
2026	217	211	54	7	8	3	2	203	6

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 Nortriptyline hydrochloride, 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 Nortriptyline hydrochloride, by the year in which FDA received them
Year	Reports
2004	1
2005	2
2007	4
2008	5
2009	4
2010	17
2011	35
2012	18
2013	8
2014	14
2015	30
2016	46
2017	43
2018	71
2019	157
2020	158
2021	168
2022	114
2023	196
2024	286
2025	200
2026	125

Reports that name Nortriptyline hydrochloride, 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 Nortriptyline hydrochloride
Age	Reports	Share
Under 2	4	0.2%
2 to 11	1	0.1%
12 to 17	4	0.2%
18 to 44	285	16.7%
45 to 64	519	30.5%
65 to 74	86	5.1%
75 and over	43	2.5%
Age not given	760	44.7%

Sex of the patient in the reports that name Nortriptyline hydrochloride
Sex	Reports	Share
Female	965	56.7%
Male	340	20%
Unknown or not given	397	23.3%

Type of reporter in the reports that name Nortriptyline hydrochloride
Reporter	Reports	Share
Physician	232	13.6%
Pharmacist	53	3.1%
Other health professional	954	56.1%
Lawyer	0	0%
Consumer or non-health professional	455	26.7%
Not given	8	0.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Nortriptyline hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Migraine	51	3%
Depression	44	2.6%
Complex regional pain syndrome	16	0.9%
Neuralgia	14	0.8%
Headache	10	0.6%
Anxiety	9	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,702 reports.

Drugs in the same reports

Other drugs that the reports of Nortriptyline hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Demerol	491
Diclofenac sodium	498
Furosemide	603
Gabapentin	629
Hydromorphone	574
Hydromorphone hydrochloride	553
Tylenol	504
Venlafaxine hydrochloride	521
Vitamin c	518
Zopiclone	568

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

Pamelor same ingredient
Nortriptyline hcl same class
Imipramine hydrochloride same class
Silenor same class
Doxepin hydrochloride same class
Trimipramine same class
Norvasc next in the A to Z list
Nortriptyline next in the A to Z list
Norvir next in the A to Z list
Northera next in the A to Z list
Noscapine next in the A to Z list
Norspan 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 Nortriptyline hydrochlorideThe 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. Nortriptyline hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/nortriptyline-hydrochloride/ 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 Nortriptyline hydrochloride as a suspect or interacting product. The 1,732 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 Nortriptyline hydrochloride 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 Nortriptyline hydrochloride?

No. It is a count of what people reported to FDA: 1,702 reports from September 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 (56.1%), consumer or non-health professional (26.7%) and physician (13.6%). 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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