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Paxil

Last reviewed on RxList: 10/29/2019
Paxil Side Effects Center

Last reviewed on RxList 10/29/2019

What Is Paxil?

Paxil (paroxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) antidepressant used to treat:

What Are Side Effects of Paxil?

Paxil is available as a generic drug. Common side effects of Paxil include:

Call your doctor immediately if you are experiencing suicidal thoughts.

Dosage for Paxil

The recommended initial dose of Paxil depends on the condition being treated and ranges from 20 mg/day to 50 mg/day.

What Drugs, Substances, or Supplements Interact with Paxil?

Paxil may interact with:

  • cold or allergy medicines,
  • sedatives,
  • narcotics,
  • sleeping pills,
  • muscle relaxers,
  • medicines for seizures or anxiety,
  • other antidepressants,
  • nonsteroidal anti-inflammatory drugs (NSAIDs),
  • blood thinners,
  • cimetidine,
  • fentanyl,
  • fosamprenavir,
  • ritonavir,
  • St. John's wort,
  • tamoxifen,
  • theophylline,
  • tramadol,
  • L-tryptophan,
  • heart medications,
  • medicines to treat psychiatric disorders,
  • almotriptan,
  • frovatriptan,
  • sumatriptan,
  • naratriptan,
  • rizatriptan, or
  • zolmitriptan

Tell your doctor all medications and supplements you use.

Paxil During Pregnancy and Breastfeeding

Tell your doctor right away if you become pregnant while taking Paxil. Paxil may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. Do not start or stop taking Paxil during pregnancy without your doctor's advice. Paxil passes into breast milk and may harm a nursing baby. Consult doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Paxil.

Additional Information

Our Paxil 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.

QUESTION

Depression is a(n) __________ . See Answer
Paxil Consumer Information

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 Paxil (Paroxetine Hydrochloride)

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Paxil Professional Information

SIDE EFFECTS

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

Clinical Trials Experience

Because 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 practice.

Safety data for PAXIL CR is from 11 short-term, placebo-controlled clinical trials including 3 studies in patients with major depressive disorder (MDD) (Studies 1, 2, and 3), 3 studies in patients with panic disorder (PD) (Studies 4, 5, and 6), 1 study in patients with social anxiety disorder (SAD) (Study 7), and 4 studies in female patients with premenstrual dysphoric disorder (PMDD) (Studies 8, 9, 10, and 11) [see Clinical Studies]. These 11 trials included 1627 patients treated with Paxil CR.

  • Studies 1 and 2 were 12-week studies that enrolled patients 18 to 65 years old who received PAXIL CR at doses ranging from 25 mg to 62.5 mg once daily. Study 3 was a 12-week study in patients 60 to 88 years old who received PAXIL CR at doses ranging from 12.5 mg to 50 mg once daily.
  • Studies 4, 5, and 6 were 10-week studies in patients 19 to 72 years old who received PAXIL CR at doses ranging from 12.5 mg to 75 mg once daily.
  • Study 7 was a 12-week study that enrolled adult patients who received PAXIL CR at doses ranging from 12.5 mg to 37.5 mg once daily.
  • Studies 8, 9, and 10 were 12-week, placebo-controlled trials in female patients 18 to 46 years old who received PAXIL CR at doses of 12.5 mg or 25 mg once daily. Study 11 was a 12-week placebo-controlled trial in patients 18 to 46 years old who received PAXIL CR 2 weeks prior to the onset of menses (luteal phase dosing) at doses of 12.5 mg or 25 mg once daily.

Adverse Reactions Leading To Discontinuation In Patients With MDD, PD, SAD, And PMDD

In pooled studies in patients with MDD, PD and SAD, the most common adverse reactions leading to study withdrawal were: nausea (up to 4% of patients), asthenia, headache, depression, insomnia, and abnormal liver function tests (each occurring in up to 2% of patients), and dizziness, somnolence, and diarrhea (each occurring in up to 1% of patients).

In pooled studies for PMDD, the most common adverse reactions leading to study withdrawal were: nausea (occurring in up to 6% of patients), asthenia (occurring in up to 5% of patients), somnolence (occurring in up to 4% of patients), insomnia (occurring in approximately 2% of patients); and impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, yawn and diarrhea (occurring in less than or equal to 2% of patients).

Adverse Reactions In MDD, PD, And SAD

Table 3 presents the most common adverse reactions in PAXIL CR-treated patients (incidence ≥5% and greater than placebo within at least 1 of the indications) in controlled trials in patients with MDD, PD, and SAD.

Table 3: Adverse Reactions (≥5% of Patients Treated with PAXIL CR and Greater than Placebo) in 10 to 12 Week Studies of MDD, PD, and SAD

Body System/ Adverse Reaction MDD18 to 65 year olds MDD≥60 years old Panic Disorder Social Anxiety Disorder
PAXIL CR
(N=212) %
Placebo
(N=211) %
PAXIL CR
(N=104) %
Placebo
(N=109 %
PAXIL CR
(N=444) %
Placebo
(N=445) %
PAXIL CR
(N=186) %
Placebo
(N=184) %
Body as a Whole
Headache 27 20 17 13 NA NA 23 17
Asthenia 14 9 15 14 15 10 18 7
Abdominal Pain 7 4 - - 6 4 5 4
Back Pain 5 3 - - NA NA 4 1
Digestive System
Nausea 22 10 - - 23 17 22 6
Diarrhea 18 7 15 9 12 9 9 8
Dry Mouth 15 8 18 7 13 9 3 2
Constipation 10 4 13 5 9 6 5 2
Flatulence 6 4 - - NA NA NA NA
Decreased Appetite 2 12 5 8 6 1 <1
Dyspepsia NA NA 13 10 NA NA 2 <1
Musculoskel etal System
Myalgia NA NA - - 5 3 NA NA
Nervous System
Somnolence 22 8 21 12 20 9 9 4
Insomnia 17 9 10 8 20 11 9 4
Dizziness 14 4 9 5 NA NA 7 4
Libido Decreased 7 3 8 <1 9 4 1
Nervousness NA NA - - 8 7 NA NA
Tremor 7 1 7 0 8 2 4 2
Anxiety NA NA - - 5 4 2 1
Respiratory System
Sinusitis NA NA - - 8 5 NA NA
Yawn 0 - - 3 0 2 0
Skin and Appendages
Sweating 6 2 10 <1 7 2 14 3
Special Senses
Abnormal Visiona 5 1 - - 3 <1 2 0
Urogenital System
Abnormal Ejaculationb,c 26 1 17 3 27 3 15 1
Female Genital Disorderb,d 10 <1 7 1 3 0
Impotenceb 5 3 9 3 10 1 9 0
Hyphen = the reaction listed occurred in <5% of patients treated with PAXIL CR
NA = the adverse reaction listed did not occur in this group of patients
a Mostly blurred vision
b Based on the number of males or females
c Mostly anorgasmia or delayed ejaculation
d Mostly anorgasmia or delayed orgasm

Other Adverse Reactions Observed During The Premarketing Evaluation Of PAXIL CR

Adverse reactions from studies in MDD (not including Study 3 in elderly patients), PD, and SAD that occurred between 1% and 5% of patients treated with PAXIL CR and at a rate greater than in placebo-treated patients include:, allergic reaction, tachycardia, vasodilatation, hypertension, migraine, vomiting, weight loss, weight gain, hypertonia, paresthesia, agitation, confusion, myoclonus, concentration impaired, depression, rhinitis, cough increased, bronchitis, photosensitivity, eczema, taste perversion, UTI, menstrual disorder, urinary frequency, urination impaired, and vaginitis.

Adverse Reactions In Patients With PMDD

Table 4 displays adverse reactions that occurred (incidence of 5% or more and greater than placebo within at least 1 of the studies) in patients treated with PAXIL CR in Studies 8, 9, 10, and 11.

Table 4: Adverse Reactions (≥5% of Patients Treated with PAXIL CR and Greater than Placebo) in Pooled Studies PMDD (Studies 8, 9, 11), and in Study 10a,b,c

Body 40%
System/Adverse Reaction
% Reporting At verse Reaction
Continuous Dosing Studies 8, 9, and 10 Luteal Phase Dosing Study 11
PAXIL CR
(n = 681) %
Placebo
(n = 349) %
PAXIL CR
(n = 246) %
Placebo
(n = 120) %
Body as a Whole
Asthenia 17 6 15 4
Headache 15 12 NA NA
Infection 6 4 NA NA
Digestive System
Nausea 17 7 18 2
Diarrhea 6 2 6 0
Constipation 5 1 2 <1
Nervous System
Libido Decreased 12 5 9 6
Somnolence 9 2 3 <1
Insomnia 8 2 7 3
Dizziness 7 3 6 3
Tremor 4 <1 5 0
Skin and Appendages
Sweating 7 <1 6 <1
Urogenital System
Female Genital Disordersc 8 1 2 0
NA= the adverse reaction information is not available in this population.
a <1% means greater than zero and less than 1%.
b The luteal phase and continuous dosing PMDD trials were not designed for making direct comparisons between the 2 dosing regimens.
c Mostly anorgasmia or difficulty achieving orgasm.

Dose Dependent Adverse Reactions

Comparison of the incidence of adverse reactions (placebo vs. 12.5 mg PAXIL CR vs. 25 mg PAXIL CR) from studies 8, 9, 10 showed the following adverse reactions to be dose-related: Nausea, somnolence, sweating, dry mouth, dizziness, decreased appetite, tremor, impaired concentration, yawn, paresthesia, hyperkinesia, and vaginitis.

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 labeling may underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in the Studies 1 and 2 (nonelderly patients with MDD), 4, 5, 6, 7, 8, 9, 10, and 11 are presented in Table 5:

Table 5: Adverse Reactions Related To Sexual Dysfunction In Patients Treated With PAXIL CR in Pooled 10-12 Week Studies of MDD, PD, SAD, and PMDD

  Studies 1 and 2 % Studies 4, 5, and 6 % Study 7 % Studies 8, 9, and 11 (Continuous Dosing) % Study 10 (Luteal Phase Dosing) %
PAXIL CR Placebo PAXIL CR Placebo PAXI L CR Placebo PAXIL CR Placebo PAXI L CR Placebo
n (males) 78 78 162 194 88 97 NA NA NA NA
Decreased Libido 10 5 9 6 13 1 NA NA NA NA
Abnormal ejaculation 26 1 27 3 15 1 NA NA NA NA
Impotence 5 3 10 1% 9 0 NA NA NA NA
n (females) 134 133 282 251 98 87 681 349 246 120
Decreased Libido 4 2 8 2 4 1 12 5 9 6
Orgasmic Disturbance 10 <1 7 1 3 0 8 1 2 0
NA = the adverse reaction listed did not occur in this group of patients.

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

Less Common Adverse Reactions

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

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 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients.

Cardiovascular System: Infrequent was postural hypotension.

Hemic and Lymphatic System: Rare was thrombocytopenia.

Metabolic and Nutritional Disorders: Infrequent were generalized edema and hypercholesteremia.

Nervous System: Infrequent were convulsion, akathisia, and manic reaction.

Psychiatric: Infrequent were hallucinations.

Skin and Appendages: Frequent was rash; infrequent was urticaria; rare was angioedema and erythema multiforme.

Urogenital System: Infrequent was urinary retention; rare was urinary incontinence.

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, 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), and vasculitic syndromes (such as Henoch-Schönlein purpura).

Read the entire FDA prescribing information for Paxil (Paroxetine Hydrochloride)

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