Paxil CRparoxetine
According to the FDA label: PAXIL CR is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) PAXIL CR is a selective serotonin reuptake inhibitor (SSRI) indicated for use in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)
58,170 adverse event reports submitted to the FDA (1998–2026)
Top Reported Adverse Events
The most frequently reported events in association with Paxil CR in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Withdrawal Syndrome 5,824 reports
The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Full definition in the glossary →Nausea 4,536 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 4,355 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Dizziness 4,274 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Anxiety 4,160 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,800 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 3,525 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Depression 3,363 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Drug Exposure During Pregnancy 3,123 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →Insomnia 2,926 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Weight Increased 2,573 reports
Diarrhoea 2,547 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 2,514 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Tremor 2,258 reports
Involuntary shaking or trembling, often in the hands.
Full definition in the glossary → See all drugs reporting this event →Paraesthesia 2,224 reports
An abnormal skin sensation such as tingling, prickling, or a pins and needles feeling. Also spelled paresthesia in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 36,370 |
| Male | 17,781 |
| Unknown | 143 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,590 |
| 18-34 | 4,614 |
| 35-49 | 7,500 |
| 50-64 | 9,250 |
| 65-74 | 4,597 |
| 75+ | 3,742 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Paxil CR. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 22,968 |
| Other Serious | 20,759 |
| Hospitalization | 15,059 |
| Death | 3,669 |
| Life-Threatening | 2,035 |
| Disability | 1,936 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Paxil CR. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1998 | 2 |
| 2003 | 4 |
| 2004 | 6,693 |
| 2005 | 6,081 |
| 2006 | 4,741 |
| 2007 | 2,990 |
| 2008 | 2,730 |
| 2009 | 2,645 |
| 2010 | 3,015 |
| 2011 | 3,115 |
| 2012 | 2,883 |
| 2013 | 1,735 |
| 2014 | 1,759 |
| 2015 | 3,466 |
| 2016 | 3,111 |
| 2017 | 1,935 |
| 2018 | 1,700 |
| 2019 | 1,713 |
| 2020 | 1,493 |
| 2021 | 1,365 |
| 2022 | 1,290 |
| 2023 | 1,169 |
| 2024 | 1,206 |
| 2025 | 1,092 |
| 2026 (partial) | 237 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Paxil CR
In FDA adverse event reports that mention Paxil CR, these medications appeared most often in the same report.
- Alprazolam (4,541 reports)
- Aspirin (3,952 reports)
- Gabapentin (3,728 reports)
- Quetiapine (3,567 reports)
- Levothyroxine (3,564 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026