What the label lists and what reports show
Fluvoxamine side effects
Fluvoxamine's FDA label: “Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥ 5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating …” FAERS holds 2,391 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 (129 reports).
- Generic listed
- Boxed warning
Check it at the source: the fluvoxamine FDA label on DailyMed (effective June 27, 2026, Zydus Pharmaceuticals USA Inc.); 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 fluvoxamine maleate extended-release capsules?Fluvoxamine maleate extended-release may cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about fluvoxamine maleate extended-release capsules?" Common possible side effects in people who take fluvoxamine include: Nausea Sleepiness Weakness Dizziness Feeling anxious Trouble sleeping Sexual problems Sweating Shaking Not feeling hungry Dry mouth Diarrhea Muscle pain Sore throat Throwing up Upset stomach Yawning Other side effects in children and adolescents taking fluvoxamine include: abnormal increase in muscle movement or agitation depression heavy menstrual periods flatulence (gas) rash Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fluvoxamine maleate extended-release capsules. […]
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥ 5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor (6.2).
Table3 PercentageofPatientsReportingSexualAdverseReactionsinPlacebo-Controlled Trials
| Reaction | Fluvoxamine Maleate Extended-Release N = 403 | Placebo N = 400 |
|---|---|---|
| Abnormal Ejaculation | 11 | 2 |
| Male | 4 | 1 |
| Female | 5 | 0 |
| Impotence | 2 | 2 |
| Male | 8 | 5 |
| Female | 4 | 2 |
| Male | 3 | 1 |
| Female | 2 | 0 |
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, continuedBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥ 5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor (6.2). The following additional reactions occurred: anxiety, decreased libido, myalgia, pharyngitis, and vomiting in the OCD population; and dyspepsia, dizziness, insomnia and yawning in another studied population. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Data Sources Fluvoxamine maleate extended-release capsules were studied in one 12-week controlled trial in patients with OCD (N = 124; mean exposure 66.6 days) and in two 12-week controlled trials for another condition (N = 279; mean exposure 59.2 days). Patients in these trials were initiated on 100 mg/day and were titrated in 50 mg increments over the first 6 weeks to within a range of 100 mg to 300 mg/day. …
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,391 reports list fluvoxamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 256 are coded as a death and 908 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 19 reactions below, 16 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fluvoxamine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions