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Desvenlafaxine Succinate side effects: what 26,837 FDA adverse event reports show

Desvenlafaxine Succinate · 1,150 reaction terms · 92,903 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Who reports

26,837 reports · 43% serious · 841 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

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 ).

FDA label, Indications and Usage

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.

FDA label, Description section

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.

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 6Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 25
What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,110 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Gastric ileus18420.0
236.5–745.8ROR 420.3 · calibrated p 1e-11 ✓
211.3 EB05 141.4 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Medication residue533200.3
182.2–220.1ROR 204.3 · calibrated p 3e-10 ✓
158.3 EB05 147.3 · IC025 +7.0
3/3 methods agree
Not in label — unassessedserious n=41not reported in cached trials
Persistent genital arousal disorder2073.3
46.4–116.0ROR 73.4 · calibrated p 3e-6 ✓
63.2 EB05 43.2 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Feelings of worthlessness4728.9
21.6–38.6ROR 28.9 · calibrated p 4e-4 ✓
27.6 EB05 21.6 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=8 · 100% consumerNCT00683800: 1/1,052 (0.1%) control
Serum serotonin increased1227.2
15.3–48.3ROR 27.2 · calibrated p 0.001 ✓
25.3 EB05 15.2 · IC025 +2.7
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
–NCT01432457: 1/300 (0.3%) on Desvenlafaxine (serious AE)
Hypoaesthesia eye1926.2
16.6–41.3ROR 26.2 · calibrated p 1e-3 ✓
24.8 EB05 16.7 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=17NCT00683800: 1/1,066 (0.1%) on Desvenlafaxine (serious AE)
Feeling guilty4225.5
18.8–34.7ROR 25.5 · calibrated p 8e-4 ✓
24.5 EB05 18.9 · IC025 +3.8
3/3 methods agree
Not in label — unassessed100% consumernot reported in cached trials
Drug screen false positive8524.5
19.7–30.4ROR 24.5 · calibrated p 8e-4 ✓
23.6 EB05 19.7 · IC025 +4.0
3/3 methods agree
Lab value / disease marker♀ 53% (drug 77%)not reported in cached trials
Electric shock sensation5716.9
13.0–22.0ROR 16.9 · calibrated p 0.005 ✓
16.4 EB05 13.1 · IC025 +3.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=27 · 75% consumernot reported in cached trials
Negative thoughts6216.8
13.1–21.6ROR 16.8 · calibrated p 0.005 ✓
16.4 EB05 13.2 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=22 · 84% consumernot reported in cached trials
Orgasm abnormal1716.8
10.4–27.1ROR 16.8 · calibrated p 0.007 ✓
15.8 EB05 10.0 · IC025 +2.7
3/3 methods agree
Labeled adverse reaction
exact term
–NCT00683800: 3/1,066 (0.3%) on Desvenlafaxine
Tenosynovitis stenosans1115.7
8.6–28.4ROR 15.7 · calibrated p 0.011 ✓
14.0 EB05 7.3 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious n=11NCT00683800: 1/1,066 (0.1%) on Desvenlafaxine; 1/1,052 (0.1%) control
Hostility4714.5
10.9–19.4ROR 14.6 · calibrated p 0.009 ✓
14.1 EB05 10.9 · IC025 +3.2
3/3 methods agree
Labeled adverse reaction
exact term
serious n=30not reported in cached trials
Phobia2114.5
9.4–22.3ROR 14.5 · calibrated p 0.011 ✓
13.6 EB05 9.0 · IC025 +2.7
3/3 methods agree
Not in label — unassessed100% consumernot reported in cached trials
Bezoar2514.4
9.7–21.4ROR 14.4 · calibrated p 0.011 ✓
13.7 EB05 9.4 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=25 · ♀ 100% (drug 77%)not reported in cached trials
Substance dependence1214.2
8.0–25.2ROR 14.2 · calibrated p 0.015 ✓
12.6 EB05 6.8 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Withdrawal syndrome73513.8
12.9–14.9ROR 14.2 · calibrated p 0.009 ✓
13.6 EB05 12.8 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious PRR 11.3 · 75% consumerNCT00683800: 1/1,052 (0.1%) control
Anorgasmia4713.7
10.3–18.3ROR 13.7 · calibrated p 0.011 ✓
13.3 EB05 10.3 · IC025 +3.1
3/3 methods agree
Labeled adverse reaction
exact term
–NCT00683800: 10/1,066 (0.9%) on Desvenlafaxine
Crying61913.5
12.5–14.6ROR 13.8 · calibrated p 0.010 ✓
13.2 EB05 12.4 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious PRR 12.7 · 73% consumerNCT00683800: 19/1,066 (1.8%) on Desvenlafaxine; 2/1,052 (0.2%) control
Iron overload1813.2
8.3–21.1ROR 13.2 · calibrated p 0.016 ✓
12.1 EB05 7.6 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Blunted affect1213.1
7.4–23.3ROR 13.1 · calibrated p 0.019 ✓
11.4 EB05 6.2 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Tachyphrenia5612.8
9.8–16.7ROR 12.8 · calibrated p 0.014 ✓
12.4 EB05 9.8 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=26not reported in cached trials
Dissociation12012.6
10.5–15.1ROR 12.7 · calibrated p 0.014 ✓
12.3 EB05 10.6 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=93NCT00683800: 2/1,066 (0.2%) on Desvenlafaxine
Yawning4212.4
9.2–16.9ROR 12.5 · calibrated p 0.017 ✓
11.9 EB05 9.0 · IC025 +2.9
3/3 methods agree
Labeled adverse reaction
exact term
serious n=15NCT00683800: 12/1,066 (1.1%) on Desvenlafaxine; 1/1,052 (0.1%) control
Product residue present8112.1
9.7–15.1ROR 12.1 · calibrated p 0.017 ✓
11.8 EB05 9.7 · IC025 +3.1
3/3 methods agree
Reporting / coding artifactserious n=19 · 72% consumernot reported in cached trials
Pre-existing condition improved8811.0
8.9–13.6ROR 11.1 · calibrated p 0.024 ✓
10.7 EB05 8.9 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=48not reported in cached trials
Sleep-related eating disorder1311.0
6.3–18.9ROR 11.0 · calibrated p 0.034 ✓
9.2 EB05 5.3 · IC025 +2.0
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Coma scale abnormal3910.8
7.9–14.8ROR 10.8 · calibrated p 0.028 ✓
10.2 EB05 7.6 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious n=39 · ♀ 57% (drug 77%) · 100% cliniciannot reported in cached trials
Bruxism7010.3
8.1–13.0ROR 10.3 · calibrated p 0.032 ✓
9.9 EB05 8.0 · IC025 +2.9
3/3 methods agree
Labeled adverse reaction
exact term
serious n=27NCT00683800: 3/1,066 (0.3%) on Desvenlafaxine
False positive investigation result1310.2
5.9–17.6ROR 10.2 · calibrated p 0.043 ✓
8.4 EB05 4.9 · IC025 +2.0
3/3 methods agree
Lab value / disease marker–not reported in cached trials
Violence-related symptom2010.1
6.5–15.8ROR 10.1 · calibrated p 0.039 ✓
9.0 EB05 5.9 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Medication residue present6210.1
7.9–13.0ROR 10.1 · calibrated p 0.033 ✓
9.7 EB05 7.7 · IC025 +2.8
3/3 methods agree
Lab value / disease markerserious n=12 · 73% consumernot reported in cached trials
Serotonin syndrome24410.1
8.9–11.4ROR 10.2 · calibrated p 0.031 ✓
9.9 EB05 8.9 · IC025 +3.1
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 13.5 · ♀ 54% (drug 77%)NCT01432457: 1/300 (0.3%) on Desvenlafaxine (serious AE)
Decreased interest729.6
7.6–12.1ROR 9.7 · calibrated p 0.039 ✓
9.2 EB05 7.5 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=16 · 83% consumerNCT00683800: 1/1,066 (0.1%) on Desvenlafaxine
Post-traumatic stress disorder809.4
7.5–11.7ROR 9.4 · calibrated p 0.042 ✓
9.0 EB05 7.5 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=74NCT00683800: 2/1,066 (0.2%) on Desvenlafaxine
Drug withdrawal syndrome1,0529.4
8.8–9.9ROR 9.7 · calibrated p 0.036 ✓
9.2 EB05 8.8 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 4.6NCT00683800: 1/1,052 (0.1%) control
Suicidal behaviour478.9
6.7–11.8ROR 8.9 · calibrated p 0.052
8.3 EB05 6.4 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=46not reported in cached trials
Tension688.8
6.9–11.2ROR 8.8 · calibrated p 0.052
8.4 EB05 6.8 · IC025 +2.6
3/3 methods agree
Labeled — boxed warning
exact term
serious n=14 · 89% consumerNCT00683800: 1/1,066 (0.1%) on Desvenlafaxine (serious AE)

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Desvenlafaxine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (16 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)2,7231.6
1.6–1.7ROR 1.7 · calibrated p 0.761
1.6 EB05 1.6 · IC025 +0.6Reporting / coding artifactserious PRR 1.9not reported in cached trials
Nausea2,4372.4
2.3–2.5ROR 2.6 · calibrated p 0.788
2.4 EB05 2.3 · IC025 +1.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.4NCT00683800: 279/1,066 (26.2%) on Desvenlafaxine; 89/1,052 (8.5%) control
Headache1,9432.4
2.3–2.5ROR 2.5 · calibrated p 0.796
2.4 EB05 2.3 · IC025 +1.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.6NCT00683800: 1/1,066 (0.1%) on Desvenlafaxine
Dizziness1,8953.0
2.9–3.1ROR 3.1 · calibrated p 0.585
3.0 EB05 2.9 · IC025 +1.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7NCT00683800: 1/1,052 (0.1%) control
Anxiety1,8185.0
4.8–5.2ROR 5.3 · calibrated p 0.205
5.0 EB05 4.8 · IC025 +2.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.8NCT00683800: 42/1,066 (3.9%) on Desvenlafaxine; 29/1,052 (2.8%) control
Fatigue (tiredness)1,6771.7
1.6–1.8ROR 1.7 · calibrated p 0.790
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.7NCT00683800: 1/1,066 (0.1%) on Desvenlafaxine (serious AE)
Insomnia (trouble sleeping)1,5744.6
4.4–4.9ROR 4.9 · calibrated p 0.251
4.6 EB05 4.4 · IC025 +2.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.2NCT00683800: 3/1,066 (0.3%) on Desvenlafaxine; 1/1,052 (0.1%) control
Depression1,3884.8
4.5–5.0ROR 5.0 · calibrated p 0.237
4.7 EB05 4.5 · IC025 +2.2
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 5.7NCT00683800: 1/1,066 (0.1%) on Desvenlafaxine (serious AE)
Off label use (used outside approved label)1,0540.9
0.9–1.0ROR 0.9 · calibrated p 0.273
0.9 EB05 0.9 · IC025 -0.2
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 1.4not reported in cached trials
Drug withdrawal syndrome1,0529.4
8.8–9.9ROR 9.7 · calibrated p 0.036 ✓
9.2 EB05 8.8 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious PRR 4.6NCT00683800: 1/1,052 (0.1%) control
Malaise (feeling unwell)1,0411.9
1.7–2.0ROR 1.9 · calibrated p 0.881
1.8 EB05 1.8 · IC025 +0.8Not in label — unassessedserious PRR 2.0 · 73% consumerNCT00683800: 8/1,066 (0.8%) on Desvenlafaxine; 4/1,052 (0.4%) control
Diarrhoea (diarrhea)9601.2
1.1–1.2ROR 1.2 · calibrated p 0.422
1.2 EB05 1.1 · IC025 +0.1Labeled adverse reaction
exact term
serious PRR 1.2NCT00683800: 79/1,066 (7.4%) on Desvenlafaxine; 56/1,052 (5.3%) control
Condition aggravated9412.4
2.3–2.6ROR 2.5 · calibrated p 0.817
2.4 EB05 2.3 · IC025 +1.2
3/3 methods agree
Reporting / coding artifactserious PRR 2.3not reported in cached trials
Pain9151.2
1.1–1.2ROR 1.2 · calibrated p 0.419
1.2 EB05 1.1 · IC025 +0.1Not in label — unassessedserious PRR 1.5NCT00683800: 1/1,052 (0.1%) control (serious AE)

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.

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 nausea, headache, dizziness, anxiety, fatigue, insomnia. 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

Page generated 2026-10-14. 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.