Pharmacologic class (EPC) · 2 drug pages

Sympathomimetic amine anorectic: adverse event reports filed with FDA

7,138 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.

7,138
reports across the class: 0% of all reports; 1,258
reports, 12 months to June 2026: 1,213 in the 12 months before; 26.1%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Sympathomimetic amine anorectic 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 7,138 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

1,258 reports arrived in the 12 months to June 2026, close to the 1,213 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 26.1% of the class's reports are marked serious, 4.8% record death among the outcomes and 8.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are headache (5.5%), paraesthesia (4.5%) and insomnia (4.4%). 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
QsymiaPhentermine and topiramate	brand	5,548	1,147	13.6%	Headache
PhenterminePhentermine hydrochloride	brand	1,590	111	69.8%	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

Headachehead pain5.5%396
Paraesthesiatingling or pins and needles4.5%321
Insomniadifficulty sleeping4.4%313
Dizzinesslight-headedness or unsteadiness4.1%290
Dry mouthdry mouth4%283
Weight increasedweight gain3.9%280
Nauseafeeling sick3.4%246
Fatiguetiredness3.3%232
Feeling abnormalfeeling odd or not right3.2%229
Anxietyanxiety3.1%223
Constipationconstipation2.9%208
Palpitationsawareness of the heartbeat2.8%198
Inappropriate schedule of product administrationthe product was taken at the wrong times2.7%194
Alopeciahair loss2.5%181
Drug ineffectivethe medicine did not work as expected2.5%179
Depressionlow mood2.2%160
Vision blurredblurred vision2.2%155
Product dose omission issuea dose was missed2%143
Hypertensionhigh blood pressure2%142
Hypoaesthesianumbness1.9%139
Malaisegeneral feeling of being unwell1.8%131
Dysgeusiaaltered taste1.7%123
Heart rate increaseda fast heart rate reading1.5%107
Drug abusemisuse of a medicine1.4%101
Adverse drug reactiona harmful or unpleasant reaction reported to a medicine1.4%100

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

Death4.8%343

Life-threatening1.6%114

Hospitalisation (initial or prolonged)8.6%615

Disability1.3%90

Congenital anomaly0.2%14

Other serious17.2%1,230

Not serious73.9%5,275

Patient age

Under 20%3

2 to 110.1%8

12 to 170.3%23

18 to 4414.7%1,046

45 to 6418.2%1,300

65 to 742.9%204

75 and over0.5%36

Age not given63.3%4,518

Who reported

Physician9%641

Pharmacist3%217

Other health professional8.9%638

Lawyer0.1%10

Consumer or non-health professional74.7%5,334

Not given4.2%298

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 amine anorectic reports

Which drugs are in the Sympathomimetic amine anorectic class on this site?

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

How many reports does the class have?

7,138 reports through June 2026, 1,258 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?

headache (5.5%), paraesthesia (4.5%), insomnia (4.4%), dizziness (4.1%) and dry mouth (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.