Two medicines, side by side
Codeine vs fentanyl
Codeine and fentanyl are both labeled for pain. Drugs@FDA records approvals of codeine since 2009 and of fentanyl since 1968. Pharmacies paid $0.726 per codeine sulfate 30 mg tablet and $1.79 per mL (Fentanyl 100 mcg/2 mL vial) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Codeine, “Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.”; Fentanyl, “Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and sedation.”
Check it at the source: the codeine FDA label on DailyMed (effective December 22, 2025); the fentanyl FDA label on DailyMed (effective March 6, 2026).
Highlights of the codeine record
Codeine · label of December 22, 2025
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of Codeine Sulfate 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 and Precautions ( 5.1 ), Dosage and Administration ( 2.1 )].
Used for
From the label: indicationsCodeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. […]
On the market
- Earliest approval on file
- July 16, 2009
- Generic labelers
- 1 labeler
- Pharmacy cost
- $0.726 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the fentanyl record
Fentanyl (Sublimaze) · label of March 6, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION Addiction, Abuse, and Misuse Because the use of Fentanyl Citrate Injection 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 and Precautions (5.1) ].
Used for
From the label: indicationsFentanyl Citrate Injection is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. use as a narcotic analgesic supplement in general or regional anesthesia. administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an […]
On the market
- Earliest approval on file
- February 19, 1968
- Generic labelers
- 6 labelers
- Pharmacy cost
- $1.79 per mL
Supply and safety
- Shortage
- In shortage
- Recalls
- 111
Source: FDA drug labels via openFDA (Codeine label of December 22, 2025, Fentanyl label of March 6, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do codeine and fentanyl differ on the record?
How each works, in its label's words: Codeine, “Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.”; Fentanyl, “Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and sedation.”
Both are in FDA's class opioid agonists.
Both labels carry a boxed warning; the records quote them.
Generics: codeine since 2014; fentanyl since 1990 (Drugs@FDA).
| Codeine | Fentanyl | |
|---|---|---|
| Labeled for | Pain | Pain |
| Pharmacologic class | Opioid Agonist | Opioid Agonist |
| How it works (label) | Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. | Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and sedation. |
| Half-life (label) | n/a | Elimination The terminal elimination half-life is 219 minutes. |
| Earliest approval on file (Drugs@FDA) | July 16, 2009 | February 19, 1968 |
| First generic approved | June 13, 2014 | April 30, 1990 |
| Generic labelers (NDC) | 1 labeler | 6 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.726 per tablet (Codeine sulfate 30 mg tablet) | $1.79 per mL (Fentanyl 100 mcg/2 mL vial) |
| 12-month price change | +8% | +76% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | In shortage |
| Recalls recorded | 0 | 111 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,295 | 114,879 |
| DEA schedule | CII | CII |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Codeine label, warnings and precautionsRisks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Codeine Sulfate Tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids …
Fentanyl label, warnings and precautionsProfound sedation, respiratory depression, coma, and death may result from the concomitant use of Fentanyl Citrate Injection with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids).
Source: FDA drug labels via openFDA
What next?
- Alternatives to codeine
- every medicine labeled for the same conditions