Dilantinphenytoin
According to the FDA label: DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )
16,521 adverse event reports submitted to the FDA (1997–2026)
Top Reported Adverse Events
The most frequently reported events in association with Dilantin 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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Convulsion 2,156 reports
Uncontrolled shaking of the body caused by sudden muscle contractions, often associated with a seizure.
Full definition in the glossary →Seizure 1,418 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 Ineffective 1,271 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 →Fall 907 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 →Drug Hypersensitivity 852 reports
An allergic-type reaction to a medication.
Full definition in the glossary →Dizziness 846 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Headache 826 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Fatigue 805 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 701 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pain 577 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Asthenia 564 reports
Physical weakness or lack of strength.
Full definition in the glossary →Rash 550 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Vomiting 532 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 510 reports
Somnolence 485 reports
Drowsiness or strong sleepiness.
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 | 8,588 |
| Male | 6,737 |
| Unknown | 90 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 422 |
| 18-34 | 1,058 |
| 35-49 | 1,979 |
| 50-64 | 3,183 |
| 65-74 | 1,693 |
| 75+ | 1,111 |
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 Dilantin. 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 | 8,302 |
| Hospitalization | 5,201 |
| Non-Serious | 4,695 |
| Death | 1,189 |
| Life-Threatening | 539 |
| Disability | 496 |
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 Dilantin. 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 |
|---|---|
| 1997 | 1 |
| 2004 | 822 |
| 2005 | 932 |
| 2006 | 743 |
| 2007 | 737 |
| 2008 | 793 |
| 2009 | 637 |
| 2010 | 954 |
| 2011 | 1,037 |
| 2012 | 1,159 |
| 2013 | 839 |
| 2014 | 896 |
| 2015 | 1,196 |
| 2016 | 981 |
| 2017 | 729 |
| 2018 | 876 |
| 2019 | 914 |
| 2020 | 804 |
| 2021 | 509 |
| 2022 | 289 |
| 2023 | 225 |
| 2024 | 179 |
| 2025 | 219 |
| 2026 (partial) | 50 |
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 Dilantin
In FDA adverse event reports that mention Dilantin, these medications appeared most often in the same report.
- Levetiracetam (2,347 reports)
- Gabapentin (1,236 reports)
- Aspirin (1,105 reports)
- Lamotrigine (1,094 reports)
- Lorazepam (988 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