Nuvigil (armodafinil) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Armodafinil

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 July 2009 to June 2026, FDA received 5,236 adverse event reports that name Nuvigil. In these reports the drug is a suspect or interacting product.

In the same period, 12,707 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 15 reports in the 12 months to June 2026 and 17 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, 15 (under 0.1%) name Nuvigil. Reports from consumers or other non-health professionals were 58.4% of the reports that name Nuvigil 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 Nuvigil 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 8 reports that name Nuvigil.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 1.

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 321 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 5,236 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 321 terms.

Reaction terms in the reports that name Nuvigil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,236 reports
Drug ineffectivethe medicine did not work as expected	750	14.3%
Headachehead pain	532	10.2%
Insomniadifficulty sleeping	394	7.5%
Nauseafeeling sick	372	7.1%
Somnolencedrowsiness	340	6.5%
Fatiguetiredness	329	6.3%
Anxiety	312	6%
Off label useused for a purpose or in a way not on the label	296	5.7%
Rashskin rash	289	5.5%
Feeling abnormalfeeling odd or not right	274	5.2%
Dizzinesslight-headedness or unsteadiness	221	4.2%
Depressionlow mood	168	3.2%
Drug ineffective for unapproved indication	151	2.9%
Palpitationsawareness of the heartbeat	144	2.8%
Tremorshaking	134	2.6%
Feeling jittery	133	2.5%
Dyspnoeashortness of breath	132	2.5%
Blood pressure increaseda raised blood pressure reading	124	2.4%
Therapeutic response unexpected	116	2.2%
Weight decreasedweight loss	116	2.2%
Drug effect decreasedthe medicine had less effect	113	2.2%
Diarrhoealoose or frequent stools	108	2.1%
Astheniaweakness or lack of energy	107	2%
Malaisegeneral feeling of being unwell	101	1.9%
Nervousness	96	1.8%
Painpain, site not specified	95	1.8%
Decreased appetitereduced appetite	94	1.8%
Vomitingbeing sick	90	1.7%
Abdominal discomfortstomach discomfort	87	1.7%
Drug tolerance	87	1.7%
Dry mouth	86	1.6%
Drug prescribing errora prescribing mistake	85	1.6%
Heart rate increaseda fast heart rate reading	85	1.6%
Chest pain	81	1.5%
Product use issuea problem in how the product was used	80	1.5%
Intentional drug misuse	78	1.5%
Pruritusitching	78	1.5%
Falla fall	74	1.4%
Confusional stateconfusion	72	1.4%
Migraine	71	1.4%
Agitationrestlessness	70	1.3%
Paraesthesiatingling or pins and needles	70	1.3%
Psychomotor hyperactivity	69	1.3%
Hypertensionhigh blood pressure	67	1.3%
Urticariahives	67	1.3%
Disturbance in attentiondifficulty concentrating	66	1.3%
Adverse eventan unwanted medical event, type not specified	64	1.2%
Drug interactionan interaction between medicines	64	1.2%
Stomatitissore mouth	64	1.2%
Irritability	63	1.2%

Download all 321 terms of Nuvigil (CSV)

The counts add to more than 5,236 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 Armodafinil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Armodafinil	Generic name	737
Nuvigil (this page)	Brand name	5,236

Sum of the separately reported names: 5,973. 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 Nuvigil, 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
2009	464	43	6	2	16	3	0	21	421
2010	890	135	12	4	45	3	0	87	755
2011	677	254	5	3	31	7	1	220	423
2012	609	121	9	3	21	2	1	94	488
2013	468	90	7	5	17	1	3	69	378
2014	429	111	6	2	34	5	3	84	318
2015	420	113	5	3	28	5	3	95	307
2016	382	83	3	1	26	2	2	61	299
2017	234	89	5	0	21	3	2	71	145
2018	164	64	1	1	24	0	1	46	100
2019	110	51	2	0	11	0	3	43	59
2020	82	36	1	1	5	1	0	33	46
2021	84	39	0	0	6	1	0	39	45
2022	67	33	1	1	6	1	0	27	34
2023	72	45	0	1	6	2	0	41	27
2024	57	33	0	1	6	1	0	29	24
2025	15	9	0	1	3	2	0	7	6
2026	12	8	0	0	1	1	3	6	4

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 Nuvigil, 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 Nuvigil, by the year in which FDA received them
Year	Reports
2009	47
2010	125
2011	228
2012	2,252
2013	476
2014	440
2015	438
2016	454
2017	229
2018	154
2019	105
2020	72
2021	51
2022	58
2023	44
2024	43
2025	11
2026	9

Reports that name Nuvigil, 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 Nuvigil
Age	Reports	Share
Under 2	20	0.4%
2 to 11	2	under 0.1%
12 to 17	23	0.4%
18 to 44	599	11.4%
45 to 64	547	10.4%
65 to 74	116	2.2%
75 and over	69	1.3%
Age not given	3,860	73.7%

Sex of the patient in the reports that name Nuvigil
Sex	Reports	Share
Female	3,199	61.1%
Male	1,712	32.7%
Unknown or not given	325	6.2%

Type of reporter in the reports that name Nuvigil
Reporter	Reports	Share
Physician	1,333	25.5%
Pharmacist	76	1.5%
Other health professional	462	8.8%
Lawyer	3	0.1%
Consumer or non-health professional	3,056	58.4%
Not given	306	5.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Nuvigil record
Indication as recorded (MedDRA)	Reports	Share
Narcolepsy	647	12.4%
Sleep apnoea syndrome	513	9.8%
Fatigue	316	6%
Somnolence	275	5.3%
Circadian rhythm sleep disorder	150	2.9%
Hypersomnia	136	2.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,236 reports.

Drugs in the same reports

Other drugs that the reports of Nuvigil name, in any role, in order of name
Drug	Reports that name the two
Adderall	168
Aspirin	167
Bupropion hydrochloride	109
Clonazepam	112
Cymbalta	206
Ergocalciferol	112
Gabapentin	132
Lisinopril	137
Synthroid	137
Xyrem	532

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for NuvigilThe 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. Nuvigil: adverse event reports that FDA received. https://reportedreactions.com/drug/nuvigil/ 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 Nuvigil as a suspect or interacting product. The 12,707 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 Nuvigil 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 Nuvigil?

No. It is a count of what people reported to FDA: 5,236 reports from July 2009 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 (58.4%), physician (25.5%) and other health professional (8.8%). 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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