This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. ( 1 )
Phenytoin oral suspension is contraindicated in patients with: A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5) ]. Reactions have included angioedema. A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8) ]. Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Hypersensitivity to phenytoin, its ingredients, or other hydantoins ( 4 , 5.5 ) A history of prior acute hepatotoxicity attributable to phenytoin ( 4 , 5.8 ) Coadministration with delavirdine ( 4 )
Withdrawal Precipitated Seizure: May precipitate status epilepticus. Dose reductions or discontinuation should be done gradually. ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. ( 5.2 ) Serious Dermatologic Reactions: Discontinue phenytoin oral suspension at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. ( 5.3 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: If signs or symptoms of hypersensitivity are present, evaluate the patient immediately. Discontinue if an alternative etiology cannot be established. ( 5.4 ) Cardiac Effects: Bradycardia and cardiac arrest have been reported. ( 5.6 ) Angioedema: Discontinue immediately if symptoms of angioedema such as facial, perioral, or upper airway swelling occur. ( 5.7 ) Hepatic Injury: Cases of acute hepatotoxicity have been reported with phenytoin oral suspension. If this occurs, immediately discontinue. ( 4 , 5.8 ) He...
The following serious adverse reactions are described elsewhere in the labeling: Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.4) ] Hypersensitivity [see Warnings and Precautions (5.5) ] Cardiac Effects [see Warnings and Precautions (5.6) ] Angioedema [see Warnings and Precautions (5.7) ] Hepatic Injury [see Warnings and Precautions (5.8) ] Hematopoietic Complications [see Warnings and Precautions (5.9) ] Effects on Vitamin D and Bone [see Warnings and Precautions (5.10) ] Exacerbation of Porphyria [see Warnings and Precautions (5.12) ] Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.13) ] Hyperglycemia [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of phenytoin were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size...
Warnings and Precautions ( 5.3 ) 2/2021
Source: FDA SPL label for Phenytoin (ATLANTIC BIOLOGICALS CORP.), effective 20250528. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 2,604 | 2,593 | 2,051 | 1,634 | 1,488 | 1,293 | 1,218 | 406 |
25,630 reports blaming this drug for every million Medicare prescriptions filled, which is 9.3× the typical drug on this site. (2,800 reports in 2024–2026, against 109,247 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 10/2023 | Class II | Amneal Pharmaceuticals of New York, LLC | Failed Dissolution Specifications |
| 05/2023 | Class II | Amneal Pharmaceuticals of New York, LLC | Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) |
| 11/2022 | Class III | Acella Pharmaceuticals, LLC | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. |
| 11/2022 | Class III | Acella Pharmaceuticals, LLC | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. |
| 02/2020 | Class I | Taro Pharmaceuticals U.S.A., Inc. | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. |
| 08/2013 | Class II | Amneal Pharmaceuticals of New York, LLC. | Failed dissolution specifications; 18 month CRT |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Phenytoin | 101,306 | $35 |
| Dilantin | 7,472 | $192 |
| Dilantin-125 | 428 | $353 |
| Phenytoin Sodium | 41 | $76 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.