Drug Safety Information for NUVIGIL (Armodafinil)

Safety-related Labeling Changes for NUVIGIL (ARMODAFINIL) Rx Drug: FDA Link

Required post-approval safety study:

Maintain a prospective, observational pregnancy exposure registry study conducted in the United States that compares the maternal, fetal, and infant outcomes of women exposed to modafinil or armodafinil during pregnancy to outcomes in an unexposed control population in the Metropolitan Atlanta Congenital Defects Program (MACDP). Collect and classify major structural and functional birth defects identified in the perinatal period through 12 months of life. Outcomes should include microcephaly, small for gestational age, low birth weight, and intrauterine growth restriction. Information on other medication use and on maternal breastmilk feeding practices should also be included. Due Date: 2027-07-31

Original FDA Drug Approval Date for NUVIGIL: 2007-06-15

Adverse Drug Reactions for NUVIGIL* (Armodafinil)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NUVIGIL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	605
2	Headache*	541
3	Nausea*	441
4	Insomnia*	407
5	Fatigue	395
6	Rash	302
7	Anxiety*	287
8	Off label use	284
9	Somnolence*	260
10	Dizziness*	255
11	Depression	232
12	Feeling abnormal	225
13	Dyspnoea	205
14	Pain	201
15	Diarrhoea	192
16	Fall	175
17	Asthenia	171
18	Weight decreased	171
19	Vomiting	148
20	Drug ineffective for unapproved indication	146

* This side effect also appears in "Top 10 Side Effects of NUVIGIL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NUVIGIL
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Narcolepsy*	2147
2	Product used for unknown indication	2054
3	Fatigue*	1782
4	Sleep apnoea syndrome*	1551
5	Somnolence*	842
6	Hypersomnia*	409
7	Circadian rhythm sleep disorder	346
8	Attention deficit/hyperactivity disorder*	258
9	Sleep disorder	228
10	Depression*	195

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for NUVIGIL

Total Reports Filed with FDA: 23029

Number of FDA Adverse Event Reports by Patient Age for NUVIGIL

Total Reports Filed with FDA: 23029*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Armodafinil (Armodafinil, Nuvigil)

Charts are based on 23029 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.