Armodafinil side effects: what 20,966 FDA adverse event reports show

Armodafinil · 1,123 reaction terms · 73,614 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

20,966 reports · 46% serious · 325 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

FDA label, Indications and Usage

What it is

Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Likely indication confounding 3Reporting / coding artifact 3Not in label — unassessed 34

What the badges mean

Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,083 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Cataplexy	165	130.7 111.1–153.6ROR 131.7 · χ² 18,634 / p <1e-300	114.0 EB05 100.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=113	not reported in cached trials
Sleep inertia	10	121.7 63.1–234.8ROR 121.8 · χ² 961 / p 3e-211	90.3 EB05 52.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=7	not reported in cached trials
Pre-existing condition improved	542	94.0 86.1–102.5ROR 96.5 · χ² 45,451 / p <1e-300	85.6 EB05 79.8 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=280	not reported in cached trials
Sleep-related eating disorder	51	57.4 43.3–76.1ROR 57.5 · χ² 2,618 / p <1e-300	53.3 EB05 42.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=30	not reported in cached trials
Narcolepsy	101	56.5 46.3–69.1ROR 56.8 · χ² 5,160 / p <1e-300	53.0 EB05 44.9 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=94	not reported in cached trials
Product administration interrupted	381	52.3 47.2–57.9ROR 53.2 · χ² 18,148 / p <1e-300	49.6 EB05 45.5 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious n=358	not reported in cached trials
Asthma exercise induced	17	51.4 31.6–83.7ROR 51.5 · χ² 752 / p 9e-166	46.5 EB05 30.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Central sleep apnoea syndrome	14	45.9 26.8–78.4ROR 45.9 · χ² 545 / p 8e-121	41.6 EB05 26.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Periodic limb movement disorder	15	42.4 25.3–71.0ROR 42.4 · χ² 542 / p 3e-120	38.8 EB05 25.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Parasomnia	27	40.0 27.3–58.8ROR 40.1 · χ² 950 / p 6e-209	37.6 EB05 27.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Abnormal sleep-related event	51	40.0 30.2–52.9ROR 40.1 · χ² 1,827 / p <1e-300	38.0 EB05 30.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=25 · 70% consumer	not reported in cached trials
Obstructive sleep apnoea syndrome	53	39.4 30.0–51.9ROR 39.5 · χ² 1,873 / p <1e-300	37.5 EB05 29.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications	serious n=50	not reported in cached trials
Sleep paralysis	55	39.0 29.8–51.1ROR 39.1 · χ² 1,923 / p <1e-300	37.1 EB05 29.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=32	not reported in cached trials
Snoring	135	37.1 31.2–44.0ROR 37.3 · χ² 4,535 / p <1e-300	35.6 EB05 30.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=75	not reported in cached trials
Enuresis	140	35.9 30.3–42.4ROR 36.1 · χ² 4,548 / p <1e-300	34.5 EB05 30.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=68	not reported in cached trials
Sleep apnoea syndrome	627	33.9 31.3–36.6ROR 34.9 · χ² 19,326 / p <1e-300	32.8 EB05 30.7 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 45.8	not reported in cached trials
Somnambulism	212	33.2 29.0–38.1ROR 33.6 · χ² 6,381 / p <1e-300	32.1 EB05 28.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=121	not reported in cached trials
Sleep attacks	15	32.6 19.5–54.6ROR 32.7 · χ² 415 / p 1e-92	30.5 EB05 19.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Rapid eye movement sleep behaviour disorder	12	31.0 17.4–55.0ROR 31.0 · χ² 309 / p 2e-69	28.8 EB05 17.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Substance use	42	28.0 20.6–38.0ROR 28.1 · χ² 1,037 / p 7e-228	27.0 EB05 20.8 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious n=22	not reported in cached trials
Drug tolerance	130	26.2 22.1–31.2ROR 26.4 · χ² 3,052 / p <1e-300	25.5 EB05 22.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=25 · 71% consumer	not reported in cached trials
Perinatal depression	11	25.3 13.9–46.0ROR 25.3 · χ² 227 / p 1e-51	23.6 EB05 13.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Immunodeficiency common variable	12	25.2 14.2–44.6ROR 25.2 · χ² 249 / p 3e-56	23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Allergy to arthropod sting	10	22.7 12.1–42.4ROR 22.7 · χ² 182 / p 1e-41	21.0 EB05 11.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Drug effect increased	69	22.0 17.3–27.9ROR 22.0 · χ² 1,330 / p 2e-291	21.4 EB05 17.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	80% consumer	not reported in cached trials
Sensorimotor disorder	10	20.5 11.0–38.3ROR 20.5 · χ² 163 / p 1e-37	18.9 EB05 10.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=9	not reported in cached trials
Postural orthostatic tachycardia syndrome	25	19.4 13.1–28.9ROR 19.4 · χ² 411 / p 1e-91	18.8 EB05 13.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Hangover	67	19.3 15.2–24.6ROR 19.3 · χ² 1,122 / p 3e-246	18.8 EB05 15.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=26	not reported in cached trials
Wisdom teeth removal	24	18.8 12.6–28.2ROR 18.8 · χ² 380 / p 7e-85	18.2 EB05 12.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=7	not reported in cached trials
Nasal septum deviation	35	18.2 13.0–25.4ROR 18.2 · χ² 542 / p 4e-120	17.7 EB05 13.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=23	not reported in cached trials
Essential tremor	19	17.3 11.0–27.2ROR 17.3 · χ² 271 / p 4e-61	16.5 EB05 10.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Sleep talking	29	17.3 12.0–24.9ROR 17.3 · χ² 421 / p 9e-94	16.7 EB05 12.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Feeling drunk	124	16.9 14.1–20.2ROR 17.0 · χ² 1,807 / p <1e-300	16.6 EB05 14.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=52	not reported in cached trials
Terminal insomnia	28	16.4 11.3–23.8ROR 16.4 · χ² 383 / p 1e-85	15.8 EB05 11.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	80% consumer	not reported in cached trials
Moaning	18	16.3 10.2–26.0ROR 16.3 · χ² 240 / p 2e-54	15.5 EB05 9.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Circadian rhythm sleep disorder	13	15.8 9.2–27.4ROR 15.9 · χ² 164 / p 9e-38	14.6 EB05 8.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=8	not reported in cached trials
Sudden onset of sleep	20	14.6 9.4–22.6ROR 14.6 · χ² 236 / p 2e-53	13.7 EB05 8.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Bruxism	76	14.3 11.4–17.9ROR 14.3 · χ² 912 / p 1e-200	14.0 EB05 11.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=27	not reported in cached trials
Binge eating	15	14.2 8.5–23.6ROR 14.2 · χ² 168 / p 1e-38	13.0 EB05 7.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=7	not reported in cached trials
Claustrophobia	15	14.0 8.4–23.3ROR 14.0 · χ² 166 / p 3e-38	12.8 EB05 7.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Armodafinil as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

NCT01121536 — Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major (N=867, PHASE3; 29 AE terms posted; arms: Armodafinil 150-200 mg/Day)
NCT00228553 — Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepine (N=743, PHASE3; 87 AE terms posted; arms: Armodafinil 100 to 250 mg/Day)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective (drug did not work)	1,574	1.2 1.1–1.3ROR 1.2 · χ² 54 / p 1e-13	1.2 EB05 1.1 · IC025 +0.2	Reporting / coding artifact	serious PRR 1.1 · 74% consumer	not reported in cached trials
Fatigue (tiredness)	1,508	1.9 1.9–2.0ROR 2.0 · χ² 715 / p 9e-158	1.9 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.0	not reported in cached trials
Nausea	1,473	1.9 1.8–2.0ROR 1.9 · χ² 616 / p 2e-136	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.9	NCT00228553: 68/731 (9.3%) on Armodafinil
Headache	1,402	2.2 2.1–2.4ROR 2.3 · χ² 991 / p 7e-218	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3	NCT01121536: 96/863 (11.1%) on Armodafinil
Anxiety	1,178	4.1 3.9–4.4ROR 4.3 · χ² 2,832 / p <1e-300	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	NCT00228553: 57/731 (7.8%) on Armodafinil
Somnolence (drowsiness)	1,101	5.5 5.2–5.8ROR 5.8 · χ² 4,068 / p <1e-300	5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.5	not reported in cached trials
Depression	1,014	4.5 4.2–4.7ROR 4.6 · χ² 2,730 / p <1e-300	4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	NCT01121536: 1/863 (0.1%) on Armodafinil (serious AE)
Insomnia (trouble sleeping)	976	3.7 3.5–3.9ROR 3.8 · χ² 1,910 / p <1e-300	3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	NCT01121536: 49/863 (5.7%) on Armodafinil
Feeling abnormal	958	4.0 3.8–4.3ROR 4.1 · χ² 2,164 / p <1e-300	4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	not reported in cached trials
Fall	894	2.7 2.5–2.9ROR 2.8 · χ² 963 / p 8e-212	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	not reported in cached trials
Dizziness	874	1.8 1.6–1.9ROR 1.8 · χ² 291 / p 2e-65	1.8 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.8	NCT00228553: 47/731 (6.4%) on Armodafinil
Weight decreased (weight loss)	746	2.7 2.5–2.9ROR 2.7 · χ² 791 / p 2e-174	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	not reported in cached trials
Pain	710	1.2 1.1–1.2ROR 1.2 · χ² 15 / p 6e-5	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 1.5	NCT00228553: 6/731 (0.8%) on Armodafinil (serious AE)
Condition aggravated	697	2.3 2.1–2.5ROR 2.4 · χ² 524 / p 3e-116	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7	not reported in cached trials
Sleep apnoea syndrome	627	33.9 31.3–36.6ROR 34.9 · χ² 19,326 / p <1e-300	32.8 EB05 30.7 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 45.8	not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Cataplexy — n=165, PRR 130.7
Pre-existing condition improved — n=542, PRR 94.0
Sleep-related eating disorder — n=51, PRR 57.4
Parasomnia — n=27, PRR 40.0
Abnormal sleep-related event — n=51, PRR 40.0
Sleep paralysis — n=55, PRR 39.0
Snoring — n=135, PRR 37.1
Enuresis — n=140, PRR 35.9
Somnambulism — n=212, PRR 33.2
Drug tolerance — n=130, PRR 26.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Armodafinil?

In FDA FAERS, the most frequently co-reported reaction terms for Armodafinil are fatigue, nausea, headache, anxiety, somnolence, depression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Armodafinil have an FDA boxed warning?

No. The FDA label retrieved for Armodafinil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Armodafinil causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 58e33a21-7816-4fa9-9fc7-c559426ad2b9, effective 20260204; matched on openfda.generic_name.exact:"ARMODAFINIL")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,123 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query ARMODAFINIL, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.