Codeine: uses, dosing, side effects & brands
Codeine is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Tablet
- Sold as
- Codeine Sulfate
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $21 for a 30-count supply — not your price
Every codeine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Codeine Sulfate.
What codeine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing codeine
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
- Actifed W/ Codeine
- Codeprex
- Fiorinal W/Codeine
- Phenergan Vc W/ Codeine
- Phenergan W/ Codeine
- Tuzistra XR
- Bromodiphenhydramine Hydrochloride and Codeine Phosphate
- Soma Compound W/ Codeine
- Acetaminophen and Codeine Phosphate
- Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
- Butalbital; Acetaminophen; Caffeine; Codeine
- Codeine, Aspirin, Apap Formula No. 2
Codeine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long codeine keeps
No codeine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Codeine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for codeine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNumerous professional organizations and regulatory agencies recommend that other agents are preferred over codeine or to avoid codeine completely during breastfeeding; however, these recommendations appear to be based on one case report that has since been discredited, and large population studies have not found codeine to be more dangerous than other opioids that have been studied less and may not be safer. Maternal use of any oral opioid in high dosages during breastfeeding can cause infant drowsiness, which can progress to more severe central nervous system depression. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If the mother of a newborn requires codeine, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral codeine to 2 to 3 days at a low dosage with close infant monitoring, especially in the outpatient setting. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. Following these precautions can lower the risk of neonatal sedation. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about codeine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3,379 reports naming codeine, and the FDA flagged 64% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- drug hypersensitivity834 reports
- nausea519 reports
- malaise388 reports
- vomiting383 reports
- headache380 reports
- arthralgia367 reports
- diarrhoea359 reports
- dyspnoea348 reports
Read these as a signal, not a rate. A report does not mean codeine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related guides
Related calculators
Frequently asked questions
Can you take codeine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run codeine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does codeine come in?
Across the brands we track, codeine is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic codeine?
Yes. Our catalog lists 1 generic codeine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has codeine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions codeine. The most recent: Guaifenesin and Codeine Phosphate Oral Solution USP (Jan 7, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
How long does codeine stay in your system and show up on a urine drug test?
Codeine is generally detectable in urine for about 1 to 2 days after the last dose, and sometimes up to roughly 3 days with higher or repeated dosing. It is a natural opiate and is detected by standard opiate immunoassays. Because the body converts some codeine to morphine, a urine test may show both codeine and morphine. Windows are approximate and depend on dose, CYP2D6 metabolism, and kidney function. This is general information, not medical or legal advice.
How long is codeine detectable in blood, saliva, and hair?
Approximate ranges from toxicology references: blood about 12 to 24 hours, oral fluid (saliva) roughly 1 to 4 days, and hair up to about 90 days. Blood clears fastest, while hair reflects the longest history of use. Individual results vary with dose and metabolism.
Why does my codeine test also show morphine?
Codeine is partly metabolized to morphine, so a urine sample after codeine use can contain both compounds. This is normal and expected, not evidence of separate morphine use — confirmatory GC-MS or LC-MS and the codeine-to-morphine ratio help a Medical Review Officer interpret it. If you take prescription codeine, disclose it to the testing provider. Detection times vary from person to person and this is not medical or legal advice.
Cite this page
- APA
- pharmaranks. (2026, July 24). Codeine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/codeine
- MLA
- “Codeine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/codeine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for codeine on DailyMed (NIH) ↗.