Pharmacologic class (EPC) · 6 drug pages

Aminoketone: adverse event reports filed with FDA

70,951 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.

70,951
reports across the class: 0.3% of all reports; 4,890
reports, 12 months to June 2026: 7,377 in the 12 months before; 57.6%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Aminoketone is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 70,951 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

4,890 reports arrived in the 12 months to June 2026, down 34% from 7,377 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 57.6% of the class's reports are marked serious, 16.5% record death among the outcomes and 20.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (10.3%), completed suicide (9.6%) and headache (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
Bupropion hydrochloride	generic	23,187	1,027	58.1%	Drug ineffective
Bupropion	generic	20,232	1,958	88%	Completed suicide
WellbutrinBupropion hydrochloride	brand	13,341	224	30.3%	Drug ineffective
Naltrexone hydrochloride and bupropion hydrochloride	generic	8,062	763	32.3%	Nausea
Bupropion hcl	generic	3,164	0	74.3%	Completed suicide
AuvelityDextromethorphan hydrobromide, bupropion hydrochloride	brand	2,965	918	19.8%	Dizziness

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 expected10.3%7,297
Completed suicidedeath by suicide9.6%6,783
Headachehead pain7%4,961
Nauseafeeling sick6.9%4,894
Toxicity to various agentspoisoning or toxic effect of one or more substances6.7%4,783
Depressionlow mood6.5%4,581
Anxietyanxiety5.6%3,975
Dizzinesslight-headedness or unsteadiness5.3%3,751
Overdosea dose above the recommended amount4.7%3,353
Fatiguetiredness4.5%3,165
Insomniadifficulty sleeping4.4%3,140
Drug interactionan interaction between medicines4.3%3,068
Feeling abnormalfeeling odd or not right3.7%2,657
Seizurea fit or convulsion3.6%2,553
Drug hypersensitivityan allergic-type reaction to a medicine3.5%2,451
Intentional overdosea deliberate overdose3.4%2,419
Off label useused for a purpose or in a way not on the label3.3%2,342
Tremorshaking3.2%2,238
Hyperhidrosisexcessive sweating3.1%2,196
Suicidal ideationthoughts of suicide3%2,130
Rashskin rash2.9%2,037
Hypertensionhigh blood pressure2.9%2,033
Painpain, site not specified2.7%1,925
Agitationrestlessness2.7%1,896
Vomitingbeing sick2.7%1,894

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death16.5%11,720

Life-threatening3.9%2,794

Hospitalisation (initial or prolonged)20.5%14,566

Disability1.7%1,172

Congenital anomaly0.5%321

Other serious38.7%27,488

Not serious42.4%30,097

Patient age

Under 20.4%275

2 to 110.3%222

12 to 172.5%1,770

18 to 4425%17,713

45 to 6423%16,304

65 to 745%3,555

75 and over1.6%1,106

Age not given42.3%30,006

Who reported

Physician19.2%13,644

Pharmacist4.8%3,396

Other health professional22.7%16,131

Lawyer0.1%103

Consumer or non-health professional49.3%34,999

Not given3.8%2,678

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 Aminoketone reports

Which drugs are in the Aminoketone class on this site?

Bupropion hydrochloride, Bupropion, Wellbutrin, Naltrexone hydrochloride and bupropion hydrochloride, Bupropion hcl and Auvelity. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

70,951 reports through June 2026, 4,890 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 (10.3%), completed suicide (9.6%), headache (7%), nausea (6.9%) and toxicity to various agents (6.7%).

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.