Pharmacologic class (EPC) · 12 drug pages

Serotonin and norepinephrine reuptake inhibitor: adverse event reports filed with FDA

171,115 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.

171,115
reports across the class: 0.8% of all reports; 6,468
reports, 12 months to June 2026: 6,912 in the 12 months before; 66.4%
marked serious by the reporter: 57.4% across all reports; 12
drugs with a page: brand and generic names counted separately

Serotonin and norepinephrine reuptake inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 12 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 171,115 adverse event reports received by FDA, 0.8% of the database, from January 2004 to June 2026.

6,468 reports arrived in the 12 months to June 2026, close to the 6,912 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 66.4% of the class's reports are marked serious, 10.2% record death among the outcomes and 24.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (9.8%), drug ineffective (9.5%) and dizziness (8.6%). 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
CymbaltaDuloxetine hydrochloride	brand	52,279	346	52.3%	Nausea
Venlafaxine	generic	29,752	2,345	93.8%	Toxicity to various agents
Venlafaxine hydrochloride	generic	19,464	1,026	80%	Drug ineffective
Duloxetine	generic	16,103	1,529	85.5%	Completed suicide
EffexorVenlafaxine hydrochloride	brand	13,079	36	60.1%	Drug withdrawal syndrome
Desvenlafaxine succinate	generic	12,414	59	29.6%	Drug ineffective
Venlafaxine hcl	generic	8,401	15	67.3%	Drug ineffective
Duloxetine hydrochloride	generic	8,245	787	82.5%	Off label use
PristiqDesvenlafaxine succinate	brand	5,941	81	41.8%	Drug ineffective
SavellaMilnacipran hydrochloride	brand	2,909	34	29.4%	Nausea
Desvenlafaxine	generic	1,436	135	78.9%	Toxicity to various agents
FetzimaLevomilnacipran hydrochloride	brand	1,092	75	53.1%	Off label use

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

Nauseafeeling sick9.8%16,821
Drug ineffectivethe medicine did not work as expected9.5%16,289
Dizzinesslight-headedness or unsteadiness8.6%14,645
Headachehead pain7.6%13,037
Drug withdrawal syndromesymptoms on stopping a medicine7.1%12,230
Anxietyanxiety6.5%11,133
Insomniadifficulty sleeping6.4%10,957
Fatiguetiredness6.4%10,866
Hyperhidrosisexcessive sweating5.3%9,115
Off label useused for a purpose or in a way not on the label5.2%8,824
Suicidal ideationthoughts of suicide5.1%8,778
Depressionlow mood5%8,610
Feeling abnormalfeeling odd or not right4.9%8,353
Paraesthesiatingling or pins and needles4.8%8,184
Drug interactionan interaction between medicines4.5%7,738
Completed suicidedeath by suicide4.3%7,302
Vomitingbeing sick4.2%7,244
Toxicity to various agentspoisoning or toxic effect of one or more substances4.1%7,080
Diarrhoealoose or frequent stools4%6,804
Painpain, site not specified3.9%6,701
Agitationrestlessness3.7%6,280
Somnolencedrowsiness3.7%6,280
Tremorshaking3.6%6,223
Malaisegeneral feeling of being unwell3.5%6,060
Confusional stateconfusion3.5%5,981

Solid bar: share of all class reports. Hollow bar: the median share across the 12 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.2%17,490

Life-threatening5%8,500

Hospitalisation (initial or prolonged)24.1%41,321

Disability3.1%5,237

Congenital anomaly1.3%2,281

Other serious44.5%76,100

Not serious33.6%57,501

Patient age

Under 20.9%1,584

2 to 110.1%239

12 to 171%1,636

18 to 4420.9%35,682

45 to 6426.1%44,693

65 to 747.9%13,587

75 and over6.3%10,851

Age not given36.7%62,843

Who reported

Physician26.9%46,091

Pharmacist5.9%10,131

Other health professional20%34,205

Lawyer0.7%1,212

Consumer or non-health professional41.4%70,769

Not given5.1%8,707

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 Serotonin and norepinephrine reuptake inhibitor reports

Which drugs are in the Serotonin and norepinephrine reuptake inhibitor class on this site?

Cymbalta, Venlafaxine, Venlafaxine hydrochloride, Duloxetine, Effexor and Desvenlafaxine succinate and 6 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

171,115 reports through June 2026, 6,468 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?

nausea (9.8%), drug ineffective (9.5%), dizziness (8.6%), headache (7.6%) and drug withdrawal syndrome (7.1%).

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.