Desvenlafaxine side effects: what 3,519 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,519 reports · 69% serious · 395 with death outcome · 73% female
Used for
Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) . Desvenlafaxine Extended-Release Tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).
What it is
Desvenlafaxine extended-release tablets are an extended-release tablets for oral administration that contain desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desve.
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the ris.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 171 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Serotonin syndrome | 120 | 37.6 31.5–44.9ROR 38.9 · χ² 4,216 / p <1e-300 | 37.2 EB05 31.9 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 31.4 · ♀ 42% (drug 73%) · 95% clinician | no trial data cached |
| Completed suicide (death by suicide) | 200 | 14.2 12.4–16.2ROR 15.0 · χ² 2,443 / p <1e-300 | 14.1 EB05 12.5 · IC025 +3.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.8 · 96% clinician | no trial data cached |
| Brain injury | 22 | 13.1 8.6–19.9ROR 13.2 · χ² 233 / p 6e-53 | 12.4 EB05 8.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 95% (drug 73%) | no trial data cached |
| Poisoning deliberate | 18 | 11.5 7.3–18.3ROR 11.6 · χ² 163 / p 1e-37 | 10.5 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Toxicity to various agents | 273 | 9.7 8.7–10.9ROR 10.4 · χ² 2,136 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Pharyngeal swelling | 13 | 8.1 4.7–13.9ROR 8.1 · χ² 74 / p 4e-18 | 6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Withdrawal syndrome | 53 | 7.5 5.7–9.8ROR 7.6 · χ² 292 / p 1e-65 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 115 | 7.5 6.3–9.0ROR 7.7 · χ² 641 / p 8e-142 | 7.3 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.3 | no trial data cached |
| Impaired gastric emptying | 16 | 7.5 4.6–12.2ROR 7.5 · χ² 83 / p 3e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Panic attack | 43 | 7.0 5.2–9.5ROR 7.1 · χ² 216 / p 3e-49 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Euphoric mood | 12 | 6.9 3.9–12.2ROR 7.0 · χ² 55 / p 5e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Paranoia | 20 | 6.9 4.4–10.7ROR 6.9 · χ² 95 / p 1e-22 | 6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 30% (drug 73%) | no trial data cached |
| Paralysis | 16 | 6.6 4.1–10.8ROR 6.7 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Drug interaction | 175 | 6.6 5.7–7.6ROR 6.9 · χ² 827 / p 3e-182 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · ♀ 52% (drug 73%) · 90% clinician | no trial data cached |
| Blood iron decreased | 13 | 6.6 3.8–11.3ROR 6.6 · χ² 56 / p 4e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 | no trial data cached |
| Intentional overdose | 70 | 6.5 5.2–8.3ROR 6.7 · χ² 324 / p 9e-73 | 6.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Seasonal allergy | 15 | 6.3 3.8–10.5ROR 6.4 · χ² 62 / p 2e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Impaired quality of life | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 61 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Coeliac disease | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 37 / p 5e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Suicide attempt | 61 | 6.0 4.7–7.7ROR 6.1 · χ² 249 / p 2e-56 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.0 · ♀ 41% (drug 73%) | no trial data cached |
| Drug withdrawal syndrome neonatal | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Tenderness | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 2e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Haemorrhage intracranial | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Brain fog | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 7e-11 | 4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Metabolic acidosis | 28 | 5.3 3.6–7.6ROR 5.3 · χ² 93 / p 3e-22 | 4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Immunodeficiency | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 9e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Shock | 20 | 5.2 3.4–8.1ROR 5.2 · χ² 64 / p 6e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Scar | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 47 / p 4e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Fibromyalgia | 21 | 5.2 3.4–7.9ROR 5.2 · χ² 66 / p 2e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 71% consumer | no trial data cached |
| Sedation | 22 | 5.0 3.3–7.6ROR 5.1 · χ² 67 / p 1e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Sleep apnoea syndrome | 16 | 5.0 3.1–8.1ROR 5.0 · χ² 47 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Schizophrenia | 10 | 4.9 2.6–9.1ROR 4.9 · χ² 27 / p 9e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Overdose | 177 | 4.9 4.2–5.6ROR 5.1 · χ² 546 / p 5e-121 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 93% clinician | no trial data cached |
| Agitation | 59 | 4.8 3.7–6.2ROR 4.8 · χ² 173 / p 9e-40 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Product substitution issue | 46 | 4.8 3.6–6.3ROR 4.8 · χ² 133 / p 4e-31 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Head discomfort | 14 | 4.7 2.8–8.0ROR 4.8 · χ² 38 / p 4e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Unresponsive to stimuli | 20 | 4.6 3.0–7.2ROR 4.7 · χ² 53 / p 1e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Sinus tachycardia | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Depression | 172 | 4.5 3.9–5.2ROR 4.7 · χ² 467 / p 6e-104 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.0 | no trial data cached |
| Mental impairment | 18 | 4.4 2.8–7.0ROR 4.4 · χ² 44 / p 1e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 273 | 9.7 8.7–10.9ROR 10.4 · χ² 2,136 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Completed suicide (death by suicide) | 200 | 14.2 12.4–16.2ROR 15.0 · χ² 2,443 / p <1e-300 | 14.1 EB05 12.5 · IC025 +3.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.8 · 96% clinician | no trial data cached |
| Anxiety | 189 | 3.9 3.4–4.5ROR 4.1 · χ² 419 / p 2e-93 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Overdose | 177 | 4.9 4.2–5.6ROR 5.1 · χ² 546 / p 5e-121 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 93% clinician | no trial data cached |
| Drug interaction | 175 | 6.6 5.7–7.6ROR 6.9 · χ² 827 / p 3e-182 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · ♀ 52% (drug 73%) · 90% clinician | no trial data cached |
| Depression | 172 | 4.5 3.9–5.2ROR 4.7 · χ² 467 / p 6e-104 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.0 | no trial data cached |
| Serotonin syndrome | 120 | 37.6 31.5–44.9ROR 38.9 · χ² 4,216 / p <1e-300 | 37.2 EB05 31.9 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 31.4 · ♀ 42% (drug 73%) · 95% clinician | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 115 | 7.5 6.3–9.0ROR 7.7 · χ² 641 / p 8e-142 | 7.3 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.3 | no trial data cached |
| Product dose omission issue | 113 | 2.4 2.0–2.8ROR 2.4 · χ² 89 / p 2e-21 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Covid-19 | 72 | 2.4 1.9–3.0ROR 2.5 · χ² 59 / p 7e-15 | 2.4 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Intentional overdose | 70 | 6.5 5.2–8.3ROR 6.7 · χ² 324 / p 9e-73 | 6.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 65 | 3.0 2.4–3.8ROR 3.0 · χ² 85 / p 1e-20 | 3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Seizure | 64 | 3.3 2.6–4.2ROR 3.4 · χ² 102 / p 3e-24 | 3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.9 | no trial data cached |
| Suicide attempt | 61 | 6.0 4.7–7.7ROR 6.1 · χ² 249 / p 2e-56 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.0 · ♀ 41% (drug 73%) | no trial data cached |
| Agitation | 59 | 4.8 3.7–6.2ROR 4.8 · χ² 173 / p 9e-40 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Brain injury — n=22, PRR 13.1
- Toxicity to various agents — n=273, PRR 9.7
- Withdrawal syndrome — n=53, PRR 7.5
- Paranoia — n=20, PRR 6.9
- Metabolic acidosis — n=28, PRR 5.3
- Fibromyalgia — n=21, PRR 5.2
- Sedation — n=22, PRR 5.0
- Unresponsive to stimuli — n=20, PRR 4.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Desvenlafaxine?
In FDA FAERS, the most frequently co-reported reaction terms for Desvenlafaxine are toxicity to various agents, anxiety, depression, serotonin syndrome, suicidal ideation, covid-19. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Desvenlafaxine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the ris.
Do FAERS signals prove that Desvenlafaxine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2dce1542-ead5-1b24-e063-6294a90a6df0, effective 20250217; matched on
openfda.generic_name.exact:"DESVENLAFAXINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 211 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.