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Fosphenytoin Injection

Fosphenytoin Injection is an anti-seizure medicine given by vein (or sometimes into a muscle) to treat generalized tonic-clonic status epilepticus and to prevent and treat seizures during neurosurgery.

Brand name Cerebyx
Drug classes Anti-epileptic Agent
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Fosphenytoin Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Fosphenytoin (Cerebyx) is a hospital-given anti-seizure medicine for status epilepticus (a prolonged seizure emergency) and seizures during neurosurgery; the body converts it to phenytoin, which blocks sodium channels to quiet runaway nerve firing, and it is a standard second step after a benzodiazepine, on the market since about 1996 and available generically. It is easier on veins than IV phenytoin, though itching during the infusion is common, along with dizziness and sleepiness. The boxed warning is about speed, because a too-fast IV infusion can cause severe low blood pressure and dangerous heart rhythms, which is why the rate is capped and the heart is monitored during and after.

Clinical pearls

  • Doses are written in phenytoin equivalents (PE), and mistaking the per-mL vial strength for the whole vial has caused fatal overdoses.
  • Phenytoin speeds the breakdown of many drugs, including apixaban, rivaroxaban, statins and birth control, so share a full medicine list.
  • Report a new rash or facial swelling at once; mention Asian ancestry or HLA-B*1502, which raises serious skin-reaction risk.
  • Tell the nurse about pain, swelling or purple-blue color spreading in the hand or arm beyond the IV site.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Giving Fosphenytoin Injection into a vein too quickly can cause severe low blood pressure and dangerous heart rhythm problems. For this reason, the infusion speed is capped, and your heart is monitored during and after the dose.

Older adults, critically ill patients, and people with low blood pressure or severe heart weakness are at highest risk. Problems have also happened in people with healthy hearts, and even at or below the recommended speed. Your care team may slow or stop the infusion if needed. Tell staff right away about chest discomfort, a racing or very slow heartbeat, lightheadedness, or fainting.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record1996
Companies listing it with the FDA8
FDA label last updatedMay 18, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Fosphenytoin Injection, written from its FDA label.

What Fosphenytoin Injection is used for

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Fosphenytoin Injection is an anti-seizure medicine used in these situations:

  • Treating generalized tonic-clonic status epilepticus
  • Preventing and treating seizures during neurosurgery
  • Short-term substitution for oral phenytoin when oral use is not possible

How Fosphenytoin Injection works

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Fosphenytoin is a prodrug. The body quickly converts it into phenytoin, which does the anti-seizure work. Phenytoin is thought to block sodium channels in nerve cells. This calms the sustained, rapid firing that drives seizures.

Fosphenytoin Injection dosage

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Fosphenytoin Injection is given by healthcare professionals, usually through a vein after dilution. It is sometimes given into a muscle. IV dosing is preferred in emergencies. Dose and speed depend on age, weight and the situation. After the first dose, follow-up doses are adjusted using blood levels of phenytoin.

  • Heart rate, blood pressure and breathing are monitored during and after IV doses.
  • Oral phenytoin is preferred when it can be used.

Dosing details from the FDA-approved label

From the Fosphenytoin Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Status Epilepticus - Adult
    • Loading dose is 15 to 20 mg PE/kg administered at 100 to 150 mg PE/min
    • Loading dose should be followed by maintenance doses
    • Maximum: Rate no greater than 150 mg PE/min
    • IM should ordinarily not be used for status epilepticus
  • Status Epilepticus - Pediatric (birth to < 17 years of age)
    • Loading dose is 15 to 20 mg PE/kg at a rate of 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower)
    • Maximum: 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower)
    • IM administration should ordinarily not be used in pediatric patients
  • Non-emergent loading dose - Adult
    • 10 to 20 mg PE/kg given IV or IM
    • Maximum: Rate no greater than 150 mg PE/min
    • Oral phenytoin should be used whenever possible
  • Maintenance dose - Adult
    • Initial daily maintenance dose is 4 to 6 mg PE/kg/day in divided doses at a rate no greater than 150 mg PE/min
    • Maximum: Rate no greater than 150 mg PE/min
    • Start at the next identified dosing interval after the loading dose; subsequent doses individualized by serum phenytoin concentrations
  • Non-emergent loading dose - Pediatric (birth to < 17 years of age)
    • 10 to 15 mg PE/kg at a rate of 1 to 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower)
    • Maximum: 150 mg PE/min
    • Oral phenytoin should be used whenever possible; IM should ordinarily not be used
  • Maintenance dose - Pediatric (birth to < 17 years of age)
    • Initial maintenance dose is 2 to 4 mg PE/kg given 12 hours after the loading dose and then every 12 hours (4 to 8 mg PE/kg/day in divided doses) at a rate of 1 to 2 mg PE/kg/min
    • Maximum: 100 mg PE/min
    • Rate of 1 to 2 mg PE/kg/min or 100 mg PE/min, whichever is slower
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The dose, concentration, and infusion rate of Fosphenytoin Sodium Injection should always be expressed as phenytoin sodium equivalents (PE) ( 2.1 ) For Status Epilepticus: Adult loading dose is 15 to 20 mg PE/kg at a rate of 100 to 150 mg PE/min ( 2.3 ) Pediatric loading dose is 15 to 20 mg PE/kg at a rate of 2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) ( 2.3 ) For Non-emergent Loading and Maintenance Dosing: Adult loading dose is 10 to 20 mg PE/kg given IV or IM; initial maintenance dose is 4 to 6 mg PE/kg/day in divided doses ( 2.4 ) Pediatric loading dose is 10 to 15 mg PE/kg at a rate of 1 to 2 mg PE/kg/min; initial maintenance dose is 2 to 4 mg PE/kg every 12 hours at a rate of 1 to 2 mg PE/kg/min (no faster than 100 mg PE/min) ( 2.4 ) Intramuscular Administration : Fosphenytoin Sodium Injection should ordinarily not be given intramuscularly ( 2.3 , 2.4 ) 2.1 Important Administration Instructions to Avoid Dosing Errors Use caution when administering Fosphenytoin Sodium Injection because of the risk of dosing errors [see Warnings and Precautions (5.1) ]. Phenytoin Sodium Equivalents (PE) The dose, concentration, and infusion rate of Fosphenytoin Sodium Injection should always be expressed as phenytoin sodium equivalents (PE). There is no need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Fosphenytoin Sodium Injection should always be prescribed and dispensed in phenytoin sodium equivalent units (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg of phenytoin sodium equivalents (mg PE). Concentration of 50 mg PE/mL Do not confuse the concentration of Fosphenytoin Sodium Injection with the total amount of drug in the vial. Errors, including fatal overdoses, have occurred when the concentration of the vial (50 mg PE/mL) was misinterpreted to mean that the total content of the vial was 50 mg PE. These errors have resulted in two- or ten-fold overdoses of Fosphenytoin Sodium Injection since each of the vials actually contains a total of 100 mg PE (2 mL vial) or 500 mg PE (10 mL vial). Ensure the appropriate volume of Fosphenytoin Sodium Injection is withdrawn from the vial when preparing the dose for administration. Attention to these details may prevent some Fosphenytoin Sodium Injection medication errors from occurring.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Fosphenytoin Injection side effects

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Common effects are usually related to the nervous system or to infusion speed:

Common side effects

  • Itching (pruritus), especially with IV use
  • Involuntary eye movements (nystagmus)
  • Dizziness
  • Sleepiness (somnolence)
  • Poor coordination or unsteadiness (ataxia)
  • Vomiting (more common in children)
  • Headache

When to get medical help

  • Fast or irregular heartbeat, a very slow heartbeat, fainting, or very low blood pressure during or after an infusion
  • A new rash, or blistering or peeling skin. Tell your care team right away.
  • Fever, swollen glands, or facial swelling, which can signal a serious allergic-type reaction (DRESS)
  • Swelling of the face, around the mouth, or of the upper airway (angioedema)
  • Yellowing of the skin or eyes, or other signs of liver injury
  • Unusual bruising, bleeding, infections, or signs of low blood counts
  • Pain, swelling, or purple-blue discoloration of the hand or limb beyond the IV site (purple glove syndrome)
  • Severe burning, itching, or tingling, often in the groin, during infusion

Fosphenytoin Injection warnings and precautions

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  • Heart risk with rapid IV infusion: severe low blood pressure and dangerous rhythms can occur.
  • Dosing errors: the vial concentration is not the total amount in the vial, and mix-ups have caused fatal overdoses.
  • Serious skin reactions and DRESS: stop at the first sign of rash unless clearly not drug-related.
  • Angioedema, liver injury and blood problems: can be serious.
  • Do not stop suddenly: seizures can worsen.
  • Local reactions: pain, swelling or discoloration beyond the IV site (purple glove syndrome).

Fosphenytoin Injection interactions

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Many drugs affect phenytoin levels, and phenytoin affects many others.

  • Azole antifungals, amiodarone, some antidepressants and acid reducers can raise phenytoin levels.
  • Carbamazepine, rifampin and St. John's wort can lower phenytoin levels.
  • Delavirdine must not be used with it because it can lose its effect.
  • Phenytoin can reduce the effect of blood thinners, oral contraceptives, statins and some HIV medicines.
  • Alcohol can change phenytoin levels.

Interactions listed in the FDA-approved label

From the Fosphenytoin Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Drugs highly bound to serum albumin: Could increase the unbound fraction of fosphenytoin; unknown whether this is clinically significant. Caution is advised when administering with other drugs that significantly bind to serum albumin.
  • Drugs that may increase phenytoin serum levels (e.g., azoles, fluoxetine, fluvoxamine, sertraline, cimetidine, omeprazole, amiodarone, warfarin, sulfonamides, ethosuximide, felbamate, oxcarbazepine, topiramate): May increase phenytoin serum levels and enhance the risk of drug toxicity. Monitor phenytoin serum levels when an interaction is suspected; phenytoin dose adjustment may be required.
  • Drugs that may decrease phenytoin serum levels (e.g., carbamazepine, vigabatrin, rifampin, St. John's wort, ritonavir, nelfinavir, fosamprenavir, chronic alcohol abuse, theophylline, antineoplastics): May decrease phenytoin serum levels. Addition or withdrawal may require adjustment of the phenytoin dose.
  • Phenobarbital, valproate sodium, valproic acid: May either increase or decrease phenytoin serum levels; the effect of phenytoin on their levels is unpredictable.
  • Delavirdine: Phenytoin can substantially reduce delavirdine concentrations, leading to loss of virologic response and possible resistance. See Contraindications.
  • Neuromuscular blocking agents (cisatracurium, pancuronium, rocuronium, vecuronium): Resistance to the neuromuscular blocking action has occurred in patients chronically administered phenytoin. Monitor closely for more rapid recovery from neuromuscular blockade than expected; infusion rate requirements may be higher.
  • Warfarin: Increased and decreased PT/INR responses have been reported when phenytoin is coadministered with warfarin.
  • Azoles (fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole): Their efficacy is impaired by phenytoin. Adjustment of dose may be required when phenytoin is added or withdrawn.
  • Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban): Their levels are decreased by phenytoin. Adjustment of dose may be required when phenytoin is added or withdrawn.
  • Valproate: Concomitant use with phenytoin has been associated with an increased risk of valproate-associated hyperammonemia. Monitor for signs and symptoms of hyperammonemia.
Read the label’s full interactions text

7 DRUG INTERACTIONS Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in clinically significant effects, caution is advised when administering fosphenytoin sodium injection with other drugs that significantly bind to serum albumin. The most significant drug interactions following administration of fosphenytoin sodium injection are expected to occur with drugs that interact with phenytoin. Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin serum levels is recommended when a drug interaction is suspected. Phenytoin or fosphenytoin sodium injection is a potent inducer of hepatic drug-metabolizing enzymes. Multiple drug interactions because of extensive plasma protein binding, saturable metabolism, and potent induction of hepatic enzymes ( 7.1 , 7.2 ) 7.1 Drugs that Affect Phenytoin or Fosphenytoin Sodium Injection Table 6 includes commonly occurring drug interactions that affect phenytoin (the active metabolite of fosphenytoin sodium injection) concentrations. However, this list is not intended to be inclusive or comprehensive. Individual prescribing information from relevant drugs should be consulted. The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve optimal clinical outcome. Table 6. Drugs That Affect Phenytoin Concentrations a The induction potency of St. John's wort may vary widely based on preparation.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Fosphenytoin Injection

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  • Do not use with a past allergy to fosphenytoin, phenytoin or other hydantoins.
  • Do not use with certain heart block or slow heart rhythm conditions.
  • Do not use after past liver injury from phenytoin or fosphenytoin.
  • Pregnancy: phenytoin may raise the risk of birth defects. Newborns may have a bleeding disorder that vitamin K can prevent.
  • Breastfeeding: phenytoin passes into breast milk.
  • Children: used in all pediatric age groups with slower infusion limits.
  • Older adults: may need lower or less frequent dosing.
  • Liver or kidney disease and low albumin: unbound phenytoin levels may need monitoring.

Fosphenytoin Injection overdose

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Overdose can cause nausea, vomiting, lethargy, abnormal heart rates, low blood pressure, fainting, and in severe cases cardiac arrest and death. Early signs of phenytoin toxicity include involuntary eye movements, unsteadiness and slurred speech. There is no specific antidote, so treatment supports breathing and circulation, and dialysis can be considered.

What Fosphenytoin Injection does in the body

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Fosphenytoin's anti-seizure effects come from phenytoin. Phenytoin modulates sodium channels in nerve cells and may also affect calcium movement. This suppresses repeated, high-frequency nerve firing. Its full anti-seizure effect is not immediate, so other measures such as an IV benzodiazepine are usually needed in status epilepticus.

How your body processes Fosphenytoin Injection

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After injection, fosphenytoin converts to phenytoin with a half-life of about 15 minutes. It is fully available after IM injection, with peak levels around 30 minutes. IV infusion rates are set so phenytoin availability matches that of standard IV phenytoin. Phenytoin half-life ranges from about 12 to 29 hours. Fosphenytoin is not excreted in urine.

How to store Fosphenytoin Injection

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Store under refrigeration at 2°C to 8°C (36°F to 46°F). stored at room temperature for more than 48 hours.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

205

Supplements & herbs that interact with Fosphenytoin Injection

205 supplements and herbal products have documented interactions with Fosphenytoin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 14
  • Moderate · 172
  • Minor · 19
Every supplement checked against Fosphenytoin Injection — ranked by severity The full interaction hub: 14 major · 172 moderate · 19 minor · every one linked to its full report. Check Fosphenytoin Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Fosphenytoin Injection has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Fosphenytoin Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Fosphenytoin Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Fosphenytoin Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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Fosphenytoin Injection treats generalized tonic-clonic status epilepticus, a prolonged seizure emergency. It also prevents and treats seizures during neurosurgery. It can stand in for oral phenytoin for a short time when you cannot take it by mouth.

How will I get it?

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A healthcare professional gives it, usually through an IV after diluting it. Sometimes it is given into a muscle. The team watches your heart, blood pressure and breathing during and after the dose.

What side effects should I expect?

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Itching, dizziness, sleepiness, unsteadiness and eye movements called nystagmus are common. Itching or tingling, often in the groin, can happen during the infusion and usually fades soon after. Slowing the infusion can help.

When should I speak up right away?

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Tell your care team about a racing or very slow heartbeat, lightheadedness, fainting, or chest discomfort. Report any rash, facial swelling, trouble breathing, fever with swollen glands, or yellow skin or eyes. Also report pain or purple discoloration around the IV site.

Does it interact with my other medicines?

▾
Yes, many drugs can raise or lower phenytoin levels, and phenytoin can weaken others like blood thinners and birth control pills. It must not be used with delavirdine. Give your team a full list of your medicines and supplements, including St. John's wort.

Is it safe in pregnancy?

▾
Phenytoin exposure before birth may raise the risk of birth defects and other problems. Seizures can also be risky in pregnancy, so talk with your prescriber about balancing the risks. Pregnant patients are encouraged to join the antiepileptic drug pregnancy registry.

Is Fosphenytoin Injection available over the counter?

▾
No. Fosphenytoin Injection is a prescription medicine: every Fosphenytoin Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Fosphenytoin Injection first available?

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The earliest FDA record we hold for Fosphenytoin Injection is from 1996: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fosphenytoin Injection was first used.

Who makes Fosphenytoin Injection?

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8 companies currently list Fosphenytoin Injection products in the FDA's NDC Directory, including Glenmark Pharmaceuticals Inc., Usa, Pfizer Laboratories Div Pfizer Inc, Amneal Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fosphenytoin Injection on HelloPharmacist

Detailed data & references for Fosphenytoin Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Fosphenytoin Injection forms and strengths (how it comes)

Fosphenytoin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fosphenytoin Injection inactive ingredients by manufacturer.

Injection

Into a muscle · Into a vein
Brands Cerebyx
How this form is used
What it may be used for
  • Fosphenytoin Injection is used for generalized tonic-clonic status epilepticus and for preventing and treating seizures during neurosurgery.
  • Fosphenytoin Injection can be substituted short-term for oral phenytoin when oral use is not possible.
Important instructions
  • Fosphenytoin Injection given IV must be diluted first and infused at a limited rate, with heart, blood pressure and breathing monitored.
  • Fosphenytoin Injection given IM should ordinarily not be used for status epilepticus or in children.
  • Fosphenytoin Injection doses are written in phenytoin sodium equivalents (PE) to avoid dosing errors.
Available strengths 1 strength
30 FDA-listed product records ⓘ

Fosphenytoin Injection on the U.S. market: products, makers and brands

How Fosphenytoin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

8 companies list 16 Fosphenytoin Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1996. Brand names on the directory include Cerebyx; the rest are generics.

1
Dose forms ⓘ
8
Labelers (makers, repackagers, distributors)
3
Brand names
16
FDA-listed product records ⓘ
1996
Earliest FDA record ⓘ
Glenmark Pharmaceuticals Inc., Usa19%
Pfizer Laboratories Div Pfizer Inc19%
Amneal Pharmaceuticals LLC13%
Gland Pharma Limited13%
Hikma Pharmaceuticals USA Inc.13%
West-Ward Pharmaceuticals Corp13%
Other makers13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Fosphenytoin Injection products

A representative set of FDA-listed product records for Fosphenytoin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
50 mg/mL Intramuscular, Intravenous Amneal Pharmaceuticals LLC × 2 listings ANDA View NDC →
50 mg/mL Intramuscular, Intravenous Fresenius Kabi USA, LLC ANDA View NDC →
50 mg/mL Intramuscular, Intravenous Gland Pharma Limited × 2 listings ANDA View NDC →
50 mg/mL Intramuscular, Intravenous Glenmark Pharmaceuticals Inc., Usa × 3 listings ANDA View NDC →
50 mg/mL Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. × 2 listings ANDA View NDC →
50 mg/mL Intramuscular, Intravenous Pfizer Laboratories Div Pfizer Inc × 3 listings NDA View NDC →
50 mg/mL Intramuscular, Intravenous Sagent Pharmaceuticals ANDA View NDC →
50 mg/mL Intramuscular, Intravenous West-Ward Pharmaceuticals Corp × 2 listings ANDA View NDC →

Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Fosphenytoin Injection NDCs →

Fosphenytoin Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Fosphenytoin recalls since July 2021.

✅No Fosphenytoin recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fosphenytoin Injection RxCUI 72236 1 dose form · 2 strengths

Look up RxCUI 72236 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Fosphenytoin Injection brand names

Fosphenytoin Injection is sold under one brand name in the FDA directory — Cerebyx. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cerebyx

Who makes Fosphenytoin Injection: manufacturers and labelers

8 companies list Fosphenytoin Injection products with the FDA. By number of product records, the largest are Glenmark Pharmaceuticals Inc., Usa, Pfizer Laboratories Div Pfizer Inc, Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Glenmark Pharmaceuticals Inc., Usa 3 Pfizer Laboratories Div Pfizer Inc 3 Amneal Pharmaceuticals LLC 2 Gland Pharma Limited 2 Hikma Pharmaceuticals USA Inc. 2 West-Ward Pharmaceuticals Corp 2 Fresenius Kabi USA, LLC 1 Sagent Pharmaceuticals 1

Fosphenytoin Injection drug class (RxNorm)

Fosphenytoin Injection belongs to the Hydantoin derivatives class.

Drug family (ATC) Hydantoin derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Fosphenytoin Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 18, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fosphenytoin Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fosphenytoin Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
Finished products in the current FDA directory
16
Companies listing them (makers, repackagers, distributors)
8
FDA labeler codes behind them ⓘ
8
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
May 18, 2025
Composite sections available
24
Linked SPL Set ID
de5a6711-4abb-4c3d-a18b-266b094ace11
Linked SPL Document ID
fcfe3e97-071d-44d8-8235-bb6b67567c18
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →