Pharmacologic class (EPC) · 2 drug pages

Sympathomimetic-like agent: adverse event reports filed with FDA

5,422 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.

5,422
reports across the class: 0% of all reports; 214
reports, 12 months to June 2026: 223 in the 12 months before; 64.2%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Sympathomimetic-like agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 5,422 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

214 reports arrived in the 12 months to June 2026, close to the 223 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 64.2% of the class's reports are marked serious, 6.3% record death among the outcomes and 20% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (13.8%), fatigue (7.9%) and somnolence (7%). 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
ProvigilModafinil	brand	2,871	19	60.4%	Drug ineffective
Modafinil	generic	2,551	195	68.4%	Drug ineffective

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 expected13.8%747
Fatiguetiredness7.9%429
Somnolencedrowsiness7%378
Headachehead pain6.7%363
Nauseafeeling sick5.8%312
Anxietyanxiety5.6%305
Drug interactionan interaction between medicines5.6%301
Off label useused for a purpose or in a way not on the label4.4%239
Insomniadifficulty sleeping4.2%229
Depressionlow mood4%217
Feeling abnormalfeeling odd or not right3.4%187
Dizzinesslight-headedness or unsteadiness3.4%183
Condition aggravatedthe condition being treated got worse2.9%158
Product substitution issuea problem after switching products2.9%157
Rashskin rash2.7%146
Suicidal ideationthoughts of suicide2.6%141
Tremorshaking2.5%138
Weight decreasedweight loss2.5%138
Hypertensionhigh blood pressure2.5%133
Drug hypersensitivityan allergic-type reaction to a medicine2.4%130
Dyspnoeashortness of breath2.4%128
Blood pressure increaseda raised blood pressure reading2.2%117
Vomitingbeing sick2.1%116
Falla fall2.1%114
Malaisegeneral feeling of being unwell2%111

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.3%339

Life-threatening2.8%154

Hospitalisation (initial or prolonged)20%1,082

Disability2.7%147

Congenital anomaly1.5%79

Other serious45.8%2,484

Not serious35.8%1,943

Patient age

Under 20.5%25

2 to 110.4%23

12 to 172.2%117

18 to 4423%1,249

45 to 6417.5%951

65 to 744.8%262

75 and over2.8%151

Age not given48.8%2,644

Who reported

Physician25.6%1,390

Pharmacist4.7%257

Other health professional17.9%969

Lawyer0.1%8

Consumer or non-health professional44.2%2,396

Not given7.4%402

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 Sympathomimetic-like agent reports

Which drugs are in the Sympathomimetic-like agent class on this site?

Provigil and Modafinil. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

5,422 reports through June 2026, 214 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 (13.8%), fatigue (7.9%), somnolence (7%), headache (6.7%) and nausea (5.8%).

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.