Prescription medicine
Levorphanol First approved as Levo-Dromoran
Levorphanol (Levo-Dromoran) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $10.65 per levorphanol 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the levorphanol FDA label on DailyMed (effective January 13, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 8719 record on Drugs@FDA; every levorphanol label on DailyMed.
Highlights of the record
FDA label of January 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF LEVORPHANOL TARTRATE TABLETS.
Addiction, Abuse, and Misuse Because the use of levorphanol tartrate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of levorphanol tartrate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of levorphanol tartrate tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of levorphanol tartrate tablets, especially by children, can result in a fatal overdose of levorphanol [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageLevorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 2 mg
- 3 mg
Tablet.
On the market
- Earliest approval on file
- January 8, 1953 Levo-Dromoran, Valeant Pharm Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first March 31, 2000; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $10.65 per tablet Levorphanol 2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 367 through July 30, 2026
What is levorphanol used for?
From the label: indications and usageLevorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration, and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including levorphanol tartrate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Conditions named in the indications of levorphanol's FDA labels, with every medicine labeled for each:
From other levorphanol labelsPain: INDICATIONS AND USAGE Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Levorphanol Tartrate), Sun Pharmaceutical Industries, Inc., effective January 13, 2026 (SPL set 438cf3ea-04fe-4626-9f0f-adcda7633651), via openFDA; the full label on DailyMed
Is there a generic for levorphanol (Levo-Dromoran)?
The FDA approved the first generic levorphanol on March 31, 2000. 5 generic applications are approved; 5 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 levorphanol from 7 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.
- 1953 earliest approval on file
- 2000 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levorphanol (Levo-Dromoran)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.65 per Levorphanol 2 mg tablet, down 34% from $16.12 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Levorphanol 2 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levorphanol 2 mg tablet | Generic | $10.65 per tablet | $319.37 | -34% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the levorphanol label say about other medicines?
The levorphanol label names 14 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 |
|---|---|---|
| Buprenorphine | warnings | Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including levorphanol. |
| Butorphanol | drug interactions | Mixed Agonist/Antagonist and Partial Opioid Analgesics The concomitant use of opioid with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of levorphanol tartrate tablets and precipitate withdrawal symptoms. |
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin … |
| Gabapentin | drug interactions | … sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. [see PRECAUTIONS; |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. … |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. [see PRECAUTIONS; |
| Mirtazapine | drug interactions | … (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Nalbuphine | drug interactions | Mixed Agonist/Antagonist and Partial Opioid Analgesics The concomitant use of opioid with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of levorphanol tartrate tablets and precipitate withdrawal symptoms. |
| Nalmefene | warnings | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings | DOSAGE AND ADMINISTRATION, Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose ]. |
| Pregabalin | drug interactions | … anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Tramadol | drug interactions | … receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Trazodone | drug interactions | … triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid … |
Source: FDA drug label (Levorphanol Tartrate), Sun Pharmaceutical Industries, Inc., effective January 13, 2026 (SPL set 438cf3ea-04fe-4626-9f0f-adcda7633651), via openFDA; the full label on DailyMed
What do FAERS reports show for levorphanol?
The FDA Adverse Event Reporting System holds 367 reports that list levorphanol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 31 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 else is labeled for the same conditions as levorphanol?
36 other medicines are given the same way (oral) and in the same FDA class as levorphanol or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as levorphanol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does levorphanol compare with medicines for the same use?
3 side-by-side pages set levorphanol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to levorphanol
- 36 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Levorphanol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other