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What the label lists and what reports show

Desvenlafaxine side effects

Desvenlafaxine's FDA label: “Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders …” FAERS holds 26,842 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (2,438 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the desvenlafaxine FDA label on DailyMed (effective January 27, 2023, Alembic Pharmaceuticals Limited); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of desvenlafaxine?

Desvenlafaxine can cause serious side effects, including: • See the beginning of this Medication Guide - Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions. • Serotonin syndrome. See “What should I tell my healthcare provider before taking desvenlafaxine?” Get medical help right away if you think that you have these syndromes. Signs and symptoms of these syndromes may include one or more of the following: • restlessness • increase in blood pressure • hallucinations (seeing and hearing things that are not real) • diarrhea • loss of coordination • coma • fast heart beat • nausea • increased body temperature • vomiting • muscle stiffness • confusion Desvenlafaxine may also cause other serious side effects, including: • New or worsened high blood pressure (hypertension). […]

Source: FDA drug label, Alembic Pharmaceuticals Limited, effective January 27, 2023 (SPL set 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

Treatment GroupProportion of Patients with Sustained Hypertension
Placebo0.5%
Desvenlafaxine 50 mg per day1.3%
Desvenlafaxine 100 mg per day0.7%
Desvenlafaxine 200 mg per day1.1%
Desvenlafaxine 400 mg per day2.3%

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Elevated Blood Pressure [see Warnings and Precautions (5.3)] Abnormal Bleeding [see Warnings and Precautions (5.4)] Angle Closure Glaucoma [see Warnings and Precautions (5.5)] Activation of Mania/Hypomania [see Warnings and Precautions (5.6)] Discontinuation Syndrome [see Warnings and Precautions (5.7)] Seizure [see Warnings and Precautions (5.8)] Hyponatremia [see Warnings and Precautions (5.9)] Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions 5.10)] Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1). …

Source: FDA drug label, Alembic Pharmaceuticals Limited, effective January 27, 2023 (SPL set 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8), via openFDA; the full label on DailyMed

What do FAERS reports show?

26,842 reports list desvenlafaxine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 841 are coded as a death and 3,589 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)2,724
  • Nausea (named in the label)2,438
  • Headache (named in the label)1,943
  • Dizziness (named in the label)1,894
  • Anxiety (named in the label)1,818
  • Fatigue (named in the label)1,677
  • Insomnia (named in the label)1,574
  • Feeling Abnormal1,451
  • Depression (a use or a product term, not a reaction)1,388
  • Off Label Use (a use or a product term, not a reaction)1,054
  • Drug Withdrawal Syndrome1,053
  • Malaise1,041
  • Diarrhoea (named in the label)960
  • Condition Aggravated (a use or a product term, not a reaction)941
  • Pain915
  • Suicidal Ideation (named in the label)836
  • Vomiting (named in the label)804
  • Somnolence (named in the label)773
  • Hyperhidrosis (named in the label)762
  • Withdrawal Syndrome735
  • Weight Increased (named in the label)690
  • Tremor (named in the label)670
  • Dyspnoea (named in the label)654
  • Crying619
  • Asthenia (named in the label)617

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Desvenlafaxine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions