Prescription medicine
Pentobarbital
Pentobarbital is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- DEA Schedule II
Check it at the source: the pentobarbital FDA label on DailyMed (effective March 8, 2024, Hikma Pharmaceuticals USA Inc.); every pentobarbital label on DailyMed.
Highlights of the record
FDA label of March 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageParenteral Sedatives.
Forms and strengths
- 50 mg/ml
Injection (solution).
On the market
- Generic approvals
- 21 first August 31, 1973; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 93 through July 30, 2026
What is pentobarbital used for?
From the label: indications and usageParenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section). Preanesthetics. Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Conditions named in the indications of pentobarbital's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Pentobarbital Sodium), Hikma Pharmaceuticals USA Inc., effective March 8, 2024 (SPL set d375b92a-baa1-4d63-9ad1-1467dcfde7d5), via openFDA; the full label on DailyMed
Is there a generic for pentobarbital?
The FDA approved the first generic pentobarbital on August 31, 1973. 21 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pentobarbital from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pentobarbital label say about other medicines?
The pentobarbital label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | Sodium valproate and valproic acid appear to decrease barbiturate metabolism; therefore, barbiturate blood levels should be monitored and appropriate dosage adjustments made as indicated. |
| Doxycycline | drug interactions | If phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely. |
| Estradiol | drug interactions | Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. |
| Griseofulvin | drug interactions | Griseofulvin: Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. |
| Phenobarbital | drug interactions | Drug interactions Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. |
| Phenytoin | drug interactions | Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently. |
| Progesterone | drug interactions | Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. |
| Valproic acid | drug interactions | Sodium valproate and valproic acid appear to decrease barbiturate metabolism; therefore, barbiturate blood levels should be monitored and appropriate dosage adjustments made as indicated. |
| Warfarin | drug interactions | Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocoumarol, dicumarol, and phenprocoumon). |
Source: FDA drug label (Pentobarbital Sodium), Hikma Pharmaceuticals USA Inc., effective March 8, 2024 (SPL set d375b92a-baa1-4d63-9ad1-1467dcfde7d5), via openFDA; the full label on DailyMed
What do FAERS reports show for pentobarbital?
The FDA Adverse Event Reporting System holds 93 reports that list pentobarbital among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 16 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pentobarbital side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other