What the label lists and what reports show
Paroxetine side effects
Paroxetine's FDA label: “Most common adverse reactions (≥ 5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital …” FAERS holds 41,809 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 fatigue (2,429 reports).
- Generic listed
- Boxed warning
Check it at the source: the paroxetine FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of paroxetine tablets?Paroxetine tablets can cause serious side effects, including: • See, “What is the most important information I should know about paroxetine tablets?” • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines. See, “Who should not take paroxetine tablets?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: o agitation o seeing or hearing things that are not real (hallucinations) o confusion o coma o fast heart beat o changes in blood pressure o dizziness o sweating o flushing o high body temperature (hyperthermia) o shaking (tremors), stiff muscles, or muscle twitching o loss of coordination o seizures o nausea, vomiting, diarrhea • Eye problems (angle-closure glaucoma). […]
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn.
Table 4: Adverse Reactions (≥ 1% of Paroxetine Tablets-Treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD
| Body System/ Adverse Reaction | Paroxetine Tablets (n = 421) % | Placebo (n = 421) % |
|---|---|---|
| Headache | 18 | 17 |
| Asthenia | 15 | 6 |
| Palpitation | 3 | 1 |
| Vasodilation | 3 | 1 |
| Sweating | 11 | 2 |
| Rash | 2 | 1 |
| Nausea | 26 | 9 |
| Dry Mouth | 18 | 12 |
| Constipation | 14 | 9 |
| Diarrhea | 12 | 8 |
| Decreased Appetite | 6 | 2 |
| Flatulence | 4 | 2 |
| Oropharynx Disorder Includes mostly “lump in throat” and “tightness in throat.” | 2 | 0 |
| Dyspepsia | 2 | 1 |
| Myopathy | 2 | 1 |
| Myalgia | 2 | 1 |
| Myasthenia | 1 | 0 |
| Somnolence | 23 | 9 |
| Dizziness | 13 | 6 |
| Insomnia | 13 | 6 |
| Tremor | 8 | 2 |
| Nervousness | 5 | 3 |
| Anxiety | 5 | 3 |
| Paresthesia | 4 | 2 |
| Libido Decreased | 3 | 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, continuedThe following adverse reactions are included in more detail in other sections of the prescribing information: • Hypersensitivity reactions to paroxetine [see Contraindications (4) ] • Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] • Serotonin Syndrome [see Warnings and Precautions (5.2) ] • Embryofetal Toxicity [see Warnings and Precautions (5.4) ] • Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] • Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] • Discontinuation Syndrome [see Warnings and Precautions (5.7) ] • Seizures [see Warnings and Precautions (5.8) ] • Angle-closure Glaucoma [see Warnings and Precautions (5.9) ] • Hyponatremia [see Warnings and Precautions (5.10) ] • Bone Fracture [see Warnings and Precautions (5.12) ] • Sexual Dysfunction [see Warnings and Precautions (5.13) ] Most common adverse reactions (≥ 5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn.
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
What do FAERS reports show?
41,809 reports list paroxetine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,358 are coded as a death and 16,709 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 18 reactions below, 11 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?
- Paroxetine: 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