Pharmacologic class (EPC) · 4 drug pages

Monoamine oxidase inhibitor: adverse event reports filed with FDA

6,012 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.

6,012
reports across the class: 0% of all reports; 133
reports, 12 months to June 2026: 158 in the 12 months before; 58.4%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Monoamine oxidase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 6,012 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

133 reports arrived in the 12 months to June 2026, down 16% from 158 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 58.4% of the class's reports are marked serious, 5.4% record death among the outcomes and 24.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (8.6%), drug interaction (5.9%) and dizziness (5.4%). 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
AzilectRasagiline mesylate	brand	2,946	30	67%	Fall
EmsamSelegiline	brand	1,334	6	18.9%	Application site erythema
NardilPhenelzine sulfate	brand	998	5	61.4%	Drug ineffective
Rasagiline	generic	734	92	91.6%	Drug interaction

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 expected8.6%517
Drug interactionan interaction between medicines5.9%352
Dizzinesslight-headedness or unsteadiness5.4%323
Depressionlow mood5.1%304
Insomniadifficulty sleeping4.7%285
Falla fall4.7%284
Tremorshaking4.5%272
Headachehead pain4.3%259
Anxietyanxiety4.2%255
Dyskinesiainvoluntary movements3.7%223
Fatiguetiredness3.6%216
Hallucinationseeing or hearing things that are not there3.3%197
Application site erythemaredness where the product was applied3.2%192
Nauseafeeling sick2.9%177
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor2.8%171
Somnolencedrowsiness2.8%168
Confusional stateconfusion2.6%158
Feeling abnormalfeeling odd or not right2.6%157
Malaisegeneral feeling of being unwell2.4%147
Condition aggravatedthe condition being treated got worse2.4%145
Weight decreasedweight loss2.4%144
Hypertensionhigh blood pressure2.3%139
Gait disturbancedifficulty walking2.3%136
Orthostatic hypotension2.2%130
Application site rash2.1%128

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.4%325

Life-threatening3.3%198

Hospitalisation (initial or prolonged)24.3%1,461

Disability3%181

Congenital anomaly0.1%6

Other serious39.1%2,351

Not serious41.6%2,501

Patient age

Under 20.1%5

2 to 110%1

12 to 170.1%6

18 to 445.3%318

45 to 6416.9%1,018

65 to 7416.4%983

75 and over17.1%1,031

Age not given44.1%2,650

Who reported

Physician27.5%1,654

Pharmacist7.5%453

Other health professional13.8%828

Lawyer0.2%10

Consumer or non-health professional46.6%2,799

Not given4.5%268

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 Monoamine oxidase inhibitor reports

Which drugs are in the Monoamine oxidase inhibitor class on this site?

Azilect, Emsam, Nardil and Rasagiline. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

6,012 reports through June 2026, 133 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 (8.6%), drug interaction (5.9%), dizziness (5.4%), depression (5.1%) and insomnia (4.7%).

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.