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Paxil CR Side Effects

Generic name: paroxetine

Medically reviewed by Drugs.com. Last updated on Apr 4, 2024.

Note: This document provides detailed information about Paxil CR Side Effects associated with paroxetine. Some dosage forms listed on this page may not apply specifically to the brand name Paxil CR.

Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders.

Because paroxetine mesylate is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communication with the prescriber.

Oral route (tablet)

Warning: Suicidal Thoughts and Behaviors. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

Paroxetine mesylate is not approved for use in pediatric patients.

Oral route (tablet; tablet, extended release; suspension)

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

Paroxetine hydrochloride is not approved for use in pediatric patients.

Common side effects of Paxil CR

Some side effects of paroxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • acid or sour stomach
  • belching
  • decreased appetite
  • heartburn
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • problems with urinating
  • runny or stuffy nose
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • trouble sleeping

Less common

  • abnormal dreams
  • change in sense of taste
  • congestion
  • discouragement, feeling sad, or empty
  • drugged feeling
  • fast or irregular breathing
  • feeling of unreality
  • headache, severe and throbbing
  • increased appetite
  • itching of the vagina or genital area
  • itching, pain, redness, or swelling of the eye or eyelid
  • lack of emotion
  • loss of interest or pleasure
  • lump in the throat
  • menstrual changes
  • pain during sexual intercourse
  • problems with memory
  • sense of detachment from self or body
  • sneezing
  • thick, white vaginal discharge with no odor or with a mild odor
  • tightness in the throat
  • tingling, burning, or prickling sensations
  • trouble concentrating
  • voice changes
  • watering of the eyes
  • weight loss
  • yawn

Incidence not known

  • decrease in smell
  • loss of sense of smell

Serious side effects of Paxil CR

Along with its needed effects, paroxetine (the active ingredient contained in Paxil CR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking paroxetine:

Less common

  • agitation
  • chest pain or tightness
  • chills
  • cold sweats
  • confusion
  • difficulty with breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • muscle pain or weakness
  • skin rash

Rare

  • absence of or decrease in body movements
  • bigger, dilated, or enlarged pupils (black part of the eye)
  • difficulty with speaking
  • dry mouth
  • fever
  • inability to move the eyes
  • incomplete, sudden, or unusual body or facial movements
  • increased sensitivity of the eyes to light
  • poor coordination
  • red or purple patches on the skin
  • restlessness
  • seizures
  • shivering
  • sweating
  • talking, feeling, and acting with excitement and activity you cannot control
  • trembling or shaking, or twitching

Incidence not known

  • back, leg, or stomach pains
  • blindness
  • blistering, peeling, or loosening of the skin
  • blue-yellow color blindness
  • blurred vision
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased frequency or amount of urine
  • decreased vision
  • difficulty with swallowing
  • electric shock sensations
  • eye pain
  • fainting
  • general body swelling
  • headache
  • high fever
  • hives or itching skin
  • inability to move the arms and legs
  • inability to sit still
  • increased thirst
  • incremental or ratchet-like movement of the muscle
  • joint pain
  • light-colored stools
  • lockjaw
  • loss of appetite
  • loss of bladder control
  • lower back or side pain
  • muscle spasm, especially of the neck and back
  • muscle tension or tightness
  • need to keep moving
  • painful or difficult urination
  • painful or prolonged erection of the penis
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • raised red swellings on the skin, the buttocks, legs, or ankles
  • red, irritated eyes
  • sensitivity to the sun
  • skin redness or soreness
  • slow heart rate
  • sores, ulcers, or white spots on the lips or in the mouth
  • spasms of the throat
  • stiff muscles
  • stomach pain
  • sudden numbness and weakness in the arms and legs
  • swelling of the breasts
  • swelling of the face, fingers, or lower legs
  • swollen or painful glands
  • tightness in the chest
  • unexpected or excess milk flow from the breasts
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • yellowing of the eyes or skin
  • decreased interest in sexual intercourse
  • delayed or inability to have an orgasm
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance

For healthcare professionals

Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release.

General

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS: The most commonly reported side effects included nausea, ejaculation disturbance/abnormal ejaculation, somnolence, and asthenia.

HYDROCHLORIDE CR FORMULATIONS: The most commonly reported side effects included headache, ejaculation disturbance, nausea, and somnolence.

MESYLATE CAPSULES: The most commonly reported side effects included headache, fatigue, lethargy, and malaise.[Ref]

Gastrointestinal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Nervous system

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Extrapyramidal symptoms such as akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, and oculogyric crisis have been associated with concomitant pimozide therapy.

Potentially life-threatening serotonin syndrome has been reported with SSRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin. Signs and symptoms associated with serotonin syndrome or neuroleptic malignant syndrome included agitation, confusion, diaphoresis, diarrhea, fever, hypertension, rigidity, and tachycardia, and were in some cases associated with concomitant use of serotonergic drugs.[Ref]

Genitourinary

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

There are several reports of priapism associated with use.[Ref]

Psychiatric

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Other

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Dermatologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Metabolic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Cardiovascular

HYDROCHLORIDE IMMEDIATE-RELEASE (IR)/MESYLATE TABLET FORMULATIONS:

FORMULATIONS:

HYDROCHLORIDE CONTROLLED-RELEASE (CR) FORMULATIONS:

MESYLATE CAPSULES:

Respiratory

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Musculoskeletal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Patients 50 years or older receiving selective serotonin reuptake inhibitors (SSRIs) have shown an increased risk of bone fractures.[Ref]

Ocular

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Immunologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

Hepatic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Hematologic

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Hypersensitivity

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

MESYLATE CAPSULES:

Renal

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

Endocrine

HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:

HYDROCHLORIDE CR FORMULATIONS:

References

1. (2001) "Product Information. Paxil (paroxetine)." GlaxoSmithKline

2. (2001) "Product Information. Paxil CR (paroxetine)." SmithKline Beecham

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. Cerner Multum, Inc. "Australian Product Information."

5. (2014) "Product Information. Brisdelle (paroxetine)." Noven Pharmaceuticals, Inc.

6. (2014) "Product Information. Pexeva (paroxetine)." Synthon Pharmaceuticals Ltd

Frequently asked questions

Further information

Paxil CR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.