Pharmacologic class (EPC) · 26 drug pages

Central nervous system stimulant: adverse event reports filed with FDA

109,804 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

109,804
reports across the class: 0.5% of all reports; 6,049
reports, 12 months to June 2026: 9,961 in the 12 months before; 45%
marked serious by the reporter: 57.4% across all reports; 26
drugs with a page: brand and generic names counted separately

Central nervous system stimulant is a pharmacologic class (an FDA Established Pharmacologic Class) with 26 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 109,804 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

6,049 reports arrived in the 12 months to June 2026, down 39% from 9,961 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 45% of the class's reports are marked serious, 7.9% record death among the outcomes and 12.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (16.8%), off label use (8.4%) and no adverse event (7.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
VyvanseLisdexamfetamine dimesylate	brand	17,546	627	25.7%	Drug ineffective
DaytranaMethylphenidate	brand	13,703	54	5.6%	No adverse event
ConcertaMethylphenidate hydrochloride	brand	10,834	281	65.2%	Drug ineffective
AdderallDextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate	brand	10,074	622	38%	Drug ineffective
Methylphenidate	generic	6,483	738	74.2%	Drug ineffective
RitalinMethylphenidate hydrochloride	brand	6,147	175	75.2%	Drug ineffective
Methylphenidate hydrochloride	generic	5,916	703	57.7%	Drug ineffective
ExcedrinAcetaminophen, aspirin, and caffeine	brand	5,530	47	27.5%	Drug ineffective
Excedrin MigraineAcetaminophen, aspirin, and caffeine	brand	4,662	97	12.1%	Product use in unapproved indication
Amphetamine	generic	4,388	486	96.1%	Toxicity to various agents
Lisdexamfetamine dimesylate	generic	4,300	713	73.1%	Intentional overdose
Caffeine	generic	3,721	348	92.8%	Toxicity to various agents
Excedrin Extra StrengthAcetaminophen, aspirin, and caffeine	brand	3,242	53	30.1%	Product use in unapproved indication
QuillivantMethylphenidate hydrochloride	brand	2,010	92	11.1%	Drug ineffective
FocalinDexmethylphenidate hydrochloride	brand	1,832	80	39.1%	Drug ineffective
Amphetamine sulfate	generic	1,474	89	93.7%	Toxicity to various agents
Dextroamphetamine sulfate	generic	1,251	57	41.2%	Drug ineffective
Lisdexamfetamine	generic	1,233	446	57.8%	Drug ineffective
Methylphenidate hcl	generic	846	0	76.2%	Drug ineffective
Dextroamphetamine	generic	800	67	66.3%	Drug ineffective
PanadolAcetaminophen	brand	712	44	98%	Off label use
Acetaminophen, aspirin (nsaid), caffeine	generic	705	49	93.8%	Drug dependence
MydayisDextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate	brand	662	20	11%	Drug ineffective
AzstarysSerdexmethylphenidate and dexmethylphenidate	brand	656	107	11.3%	Drug ineffective
Dexmethylphenidate hydrochloride	generic	568	51	21.7%	Drug ineffective
MidolAcetaminophen, caffeine and pyrilamine maleate	brand	509	3	29.9%	Dysmenorrhoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected16.8%18,421
Off label useused for a purpose or in a way not on the label8.4%9,211
No adverse eventno adverse event was reported7.6%8,323
Product quality issuea problem with the product itself6.8%7,429
Product use in unapproved indicationused for a purpose not on the label4.4%4,849
Toxicity to various agentspoisoning or toxic effect of one or more substances4.4%4,781
Headachehead pain4.3%4,737
Anxietyanxiety4.2%4,622
Insomniadifficulty sleeping3.6%3,966
Fatiguetiredness3.6%3,904
Disturbance in attentiondifficulty concentrating3.5%3,869
Drug abusemisuse of a medicine3.2%3,482
Drug effective for unapproved indication3.1%3,408
Nauseafeeling sick3.1%3,361
Feeling abnormalfeeling odd or not right3%3,250
Decreased appetitereduced appetite2.9%3,150
Product availability issuethe product was not available2.8%3,093
Depressionlow mood2.7%3,017
Somnolencedrowsiness2.6%2,870
Overdosea dose above the recommended amount2.5%2,697
Aggressionaggressive behaviour2.4%2,619
Product use issuea problem in how the product was used2.4%2,601
Dizzinesslight-headedness or unsteadiness2.1%2,353
Product substitution issuea problem after switching products2%2,215
Irritabilityirritability2%2,180

Solid bar: share of all class reports. Hollow bar: the median share across the 26 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.9%8,718

Life-threatening2.8%3,110

Hospitalisation (initial or prolonged)12.9%14,142

Disability2%2,205

Congenital anomaly0.6%642

Other serious32.4%35,612

Not serious55%60,415

Patient age

Under 20.4%388

2 to 1110.6%11,691

12 to 177.6%8,393

18 to 4418.2%20,020

45 to 647.4%8,152

65 to 741.5%1,671

75 and over0.9%966

Age not given53.3%58,523

Who reported

Physician16.7%18,301

Pharmacist5.8%6,395

Other health professional16.4%17,957

Lawyer0.4%461

Consumer or non-health professional57.1%62,712

Not given3.6%3,978

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Central nervous system stimulant reports

Which drugs are in the Central nervous system stimulant class on this site?

Vyvanse, Daytrana, Concerta, Adderall, Methylphenidate and Ritalin and 20 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

109,804 reports through June 2026, 6,049 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (16.8%), off label use (8.4%), no adverse event (7.6%), product quality issue (6.8%) and product use in unapproved indication (4.4%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.