Last updated on RxList: 1/7/2021
Pexeva Side Effects Center

What Is Pexeva?

Pexeva (paroxetine mesylate) is a selective serotonin reuptake inhibitor (SSRI) type of antidepressant used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

What Are Side Effects of Pexeva?

Common side effects of Pexeva include:

  • nausea,
  • drowsiness,
  • dizziness,
  • trouble sleeping (insomnia),
  • loss of appetite,
  • weakness,
  • dry mouth,
  • sweating,
  • blurred vision,
  • yawning,
  • headache,
  • restlessness,
  • nervousness,
  • constipation,
  • weight changes,
  • decreased sex drive,
  • impotence,
  • difficulty having an orgasm, or
  • ringing in your ears.

Report any worsening depression or suicidal thoughts you may have while taking Pexeva to your doctor. Tell your doctor if you have serious side effects of Pexeva including:

  • shakiness (tremor),
  • inability to keep still,
  • numbness or tingling,
  • easy bruising or bleeding,
  • fast or irregular heartbeat,
  • muscle weakness or spasm, or
  • seizures.

Dosage for Pexeva

The recommended initial dose of Pexeva is 20 mg/day.

What Drugs, Substances, or Supplements Interact with Pexeva?

Pexeva may interact with cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, medicine for seizures or anxiety, nonsteroidal anti-inflammatory drugs (NSAIDs), blood thinners, cimetidine, fentanyl, fosamprenavir, linezolid, ritonavir, St. John's wort, tamoxifen, theophylline, tramadol, tryptophan, heart medications, other antidepressants, medicine to treat psychiatric disorders, almotriptan, frovatriptan, sumatriptan, naratripta, rizatriptan, or zolmitriptan. Tell your doctor all medications and supplements you use.

Pexeva During Pregnancy and Breastfeeding

Pexeva is not recommended for use during pregnancy. It may harm a fetus. Babies born to mothers who have used this drug during the last 3 months of pregnancy may develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice symptoms in your newborn, tell the doctor. Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. This drug passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Additional Information

Our Pexeva (paroxetine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Pexeva Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • unusual bone pain or tenderness, swelling or bruising;
  • changes in weight or appetite;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting; or
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • vision changes;
  • weakness, drowsiness, dizziness, tiredness;
  • sweating, anxiety, shaking;
  • sleep problems (insomnia);
  • loss of appetite, nausea, vomiting, diarrhea, constipation;
  • dry mouth, yawning;
  • infection;
  • headache; or
  • decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pexeva (Paroxetine Mesylate)


Depression is a(n) __________ . See Answer
Pexeva Professional Information


The following adverse reactions are included in more detail in other sections of the prescribing information:

  • Hypersensitivity reactions to paroxetine [see CONTRAINDICATIONS]
  • Suicidal Thoughts and Behaviors [see WARNINGS AND PRECAUTIONS]
  • Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
  • Embryofetal and Neonatal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS]
  • Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
  • Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
  • Angle-closure Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Hyponatremia [see WARNINGS AND PRECAUTIONS]
  • Bone Fracture [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot directly be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data for paroxetine are from:

  • 6-week clinical trials in MDD patients who received paroxetine 20 mg to 50 mg once daily
  • 12-week clinical trials in OCD patients who received paroxetine 20 mg to 60 mg once daily
  • 10-to 12-week clinical trials in PD patients who received paroxetine 10 mg to 60 mg once daily
  • 8-week clinical trials in GAD patients who received paroxetine 10 mg to 50 mg once daily
Adverse Reactions Leading To Discontinuation

Twenty percent (1199/6145) of patients treated with paroxetine in clinical trials in MDD and 11.8% (64/542), 9.4% (44/469), and 10.7% (79/735) of patients treated with paroxetine in clinical trials in OCD, PD, and GAD, respectively, discontinued treatment due to an adverse reaction. Table 3 shows the most common reactions (≥1%) associated with discontinuation and considered to be drug related (i.e., those reactions associated with dropout at a rate approximately twice or greater for paroxetine compared to placebo).

TABLE 3: Adverse Reactions Reported as Leading to Discontinuation (≥1% of Paroxetine-Treated Patients and (≥2% Placebo) in MDD, OCD, PD, and GAD Trials

Paroxetine %Placebo %Paroxetine %Placebo %Paroxetine %Placebo %Paroxetine %Placebo %
  Dry mouth1.00.3------
  Abnormal Ejaculation 11.602.10--2.50.5
  Impotence 1--1.50----
Where numbers are not provided the incidence of the adverse reactions in patients treated with paroxetine was not >1% or was not greater than or equal to two times the incidence of placebo.
1 Incidence corrected for gender.

Most Common Adverse Reactions In MDD, OCD, PD, And GAD

The most commonly observed adverse reactions associated with the use of PEXEVA (incidence of 5% or greater and at least twice that for placebo) were:

Major Depressive Disorder: asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

Obsessive Compulsive Disorder: nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

Panic Disorder: asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

Generalized Anxiety Disorder: asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

Adverse Reactions Occurring At An Incidence Of 1% Or More In Paroxetine Treated Patients

Major Depressive Disorder: Table 3 enumerates adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of paroxetine-treated patients with MDD.

TABLE 4: Adverse Reactions (≥1% of Paroxetine-treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD

Body SystemPreferred TermParoxetine
Body as a WholeHeadache1817
Dry Mouth1812
Decreased Appetite62
Oropharynx Disorder 120
Nervous SystemSomnolence239
Libido Decreased30
Drugged Feeling21
Special SensesBlurred Vision41
Taste Perversion20
Urogenital SystemEjaculatory Disturbance 2,3130
Other Male Genital Disorders 2,4100
Urinary Frequency31
Urination Disorder 530
Female Genital Disorders 2,620
1 Includes mostly “lump in throat” and “tightness in throat.”
2 Percentage corrected for gender.
3 Mostly “ejaculatory delay.”
4 Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction” and “impotence.”
5 Includes mostly “difficulty with micturition” and “urinary hesitancy.”
6 Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.”

Obsessive Compulsive Disorder and Panic Disorder: Table 5 enumerates adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with OCD and PD.

TABLE 5: Adverse Reactions (≥2% of Paroxetine-Treated Patients and Greater than Placebo) in 10-to 12-Week Clinical Trials for OCD and PD

Body SystemPreferred TermObsessive Compulsive DisorderPanic Disorder
Body as a WholeAsthenia2214145
Abdominal Pain--43
Chest Pain32--
Back Pain--32
Dry Mouth1891811
Decreased Appetite9373
Increased Appetite4321
Nervous SystemInsomnia24131810
Libido Decreased7491
Abnormal Dreams41--
Concentration Impaired32--
Respiratory SystemRhinitis--30
Special SensesAbnormal Vision42--
Taste Perversion20--
Urogenital SystemAbnormal Ejaculation 1231211
Female Genital Disorder 13091
Impotence 18150
Urinary Frequency3120
Urination Impaired30--
Urinary Tract Infection2121
1 Percentage corrected for gender.

Generalized Anxiety Disorder: Table 6 enumerates adverse reactions that occurred at a frequency of 2% or more among GAD patients on paroxetine who participated in placebo-controlled trials of 8-weeks duration in which patients were dosed in a range of 10 mg/day to 50 mg/day.

TABLE 6: Adverse Reactions (≥2% of Paroxetine-Treated Patients and Greater than Placebo) in 8-Week Clinical Trials for GAD

Body SystemPreferred TermParoxetine
Body as a WholeAsthenia146
Dry Mouth115
Decreased Appetite51
Nervous SystemInsomnia118
Libido Decreased92
Respiratory SystemRespiratory Disorder75
Special SensesAbnormal Vision21
Urogenital SystemAbnormal Ejaculation 1252
Female Genital Disorder 141
Impotence 143
1 Percentage corrected for gender.

Dose Dependency Of Adverse Reactions

A comparison of adverse reaction rates in a fixed-dose study comparing paroxetine 10, 20, 30, and 40 mg/day with placebo in the treatment of MDD revealed a clear dose dependency for some of the more common adverse reactions associated with paroxetine use, as shown in Table 7:

TABLE 7: Adverse Reactions (≥5% of Paroxetine-Treated Patients and Twice that of Placebo) in a Dose-Comparison Trial in the Treatment of MDD*

Body System/ Preferred TermPlaceboParoxetine
10 mg
20 mg
30 mg
40 mg
Body as a Whole
  Decreased Appetite2.
  Dry Mouth2.010.818.315.820.6
Nervous System
Special Senses
  Blurred Vision Urogenital System2.
  Abnormal Ejaculation05.86.510.613.0
  Male Genital Disorders03.

In a fixed-dose study comparing placebo and paroxetine 20, 40, and 60 mg in the treatment of OCD, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned. No new adverse reactions were observed in the paroxetine 60 mg dose group compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and paroxetine 10, 20, and 40 mg in the treatment of PD, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned, except for asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation. In flexible-dose studies, no new adverse reactions were observed in patients receiving 60 mg of paroxetine compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and 20 and 40 mg of paroxetine in the treatment of GAD, for most of the adverse reactions, there was no clear relationship between adverse reactions and the dose of paroxetine to which patients were assigned, except for the following adverse reactions: asthenia, constipation, and abnormal ejaculation.

Male And Female Sexual Dysfunction

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in males and females with MDD, OCD, PD, , GAD, and two other indications are displayed in Table 8.

Table 8: Incidence of Sexual Adverse Reactions in Controlled Clinical Trials

n (males)1446
  Decreased Libido6 to 150 to 5
  Ejaculatory Disturbance13 to 280 to 2
  Impotence2 to 90 to 3
n (females)1822
  Decreased Libido0 to 90 to 2
  Orgasmic Disturbance2 to 90 to 1

There are no adequate and well-controlled studies examining sexual dysfunction with paroxetine treatment.

Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, healthcare providers should routinely inquire about such possible side effects.


In pooled clinical trials of immediate-release paroxetine hydrochloride, hallucinations were observed in 0.2% of paroxetine-treated patients compared to 0.1% of patients receiving placebo.

Other Reactions Observed During The Premarketing Evaluation Of Paroxetine

Less Common Adverse Reactions

The following adverse reactions occurred during the clinical studies of paroxetine and are not included elsewhere in the labeling.

Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare adverse reactions are those occurring in fewer than 1/1000 patients.

Body as a Whole: infrequent: allergic reaction, chills, face edema, malaise, neck pain; rare: adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.

Cardiovascular System: frequent: hypertension, tachycardia; infrequent : bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarction, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.

Digestive System: infrequent: bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, abnormal liver function tests , rectal hemorrhage, ulcerative stomatitis; rare: aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, chlolelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.

Endocrine System: rare: diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.

Hemic and Lymphatic Systems: infrequent: anemia, leukopenia, lymphadenopathy, purpura; rare: abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional: frequent : weight gain; infrequent: edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.

Musculoskeletal System: frequent: arthralgia; infrequent: arthritis, arthrosis; rare: bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.

Nervous System: frequent: emotional lability, vertigo; infrequent: abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.

Respiratory System: infrequent: asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.

Skin and Appendages: frequent: pruritus; infrequent: acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis, herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.

Special Senses: frequent: tinnitus; infrequent: abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.

Urogenital System: infrequent: amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, pyuria, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

Postmarketing Experience

The following reactions have been identified during post approval use of paroxetine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion (SIADH), prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide; trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura) and premature births in pregnant women. There has been a case report of severe hypotension when paroxetine was added to chronic metoprolol treatment.

Read the entire FDA prescribing information for Pexeva (Paroxetine Mesylate)

© Pexeva Patient Information is supplied by Cerner Multum, Inc. and Pexeva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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