Tegretol XRcarbamazepine
According to the FDA label: Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3.
63,763 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tegretol XR 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.
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Drug Ineffective 4,834 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 →Seizure 3,541 reports
A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Full definition in the glossary →Drug Interaction 3,365 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Fall 2,957 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Dizziness 2,763 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 2,657 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Toxicity to Various Agents 2,626 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Off Label Use 2,601 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 2,564 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Vomiting 2,465 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Fatigue 2,364 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Convulsion 2,359 reports
Uncontrolled shaking of the body caused by sudden muscle contractions, often associated with a seizure.
Full definition in the glossary →Somnolence 2,308 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Rash 2,246 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Pain 2,232 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →
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 | 33,485 |
| Male | 23,981 |
| Unknown | 367 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,680 |
| 18-34 | 7,641 |
| 35-49 | 9,514 |
| 50-64 | 10,851 |
| 65-74 | 5,504 |
| 75+ | 4,699 |
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 Tegretol XR. 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 |
|---|---|
| Other Serious | 35,246 |
| Hospitalization | 24,944 |
| Non-Serious | 8,523 |
| Death | 5,434 |
| Life-Threatening | 3,760 |
| Disability | 1,792 |
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 Tegretol XR. 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 |
|---|---|
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 1,433 |
| 2005 | 1,784 |
| 2006 | 1,706 |
| 2007 | 1,642 |
| 2008 | 1,894 |
| 2009 | 2,339 |
| 2010 | 2,300 |
| 2011 | 2,509 |
| 2012 | 3,263 |
| 2013 | 2,548 |
| 2014 | 2,835 |
| 2015 | 3,456 |
| 2016 | 3,562 |
| 2017 | 3,668 |
| 2018 | 4,450 |
| 2019 | 4,158 |
| 2020 | 3,496 |
| 2021 | 3,832 |
| 2022 | 3,419 |
| 2023 | 2,915 |
| 2024 | 2,922 |
| 2025 | 2,911 |
| 2026 (partial) | 714 |
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 Tegretol XR
In FDA adverse event reports that mention Tegretol XR, these medications appeared most often in the same report.
- Levetiracetam (8,215 reports)
- Lamotrigine (5,684 reports)
- Levetiracetam In (5,520 reports)
- Gabapentin (5,291 reports)
- Clonazepam (4,277 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