What the FDA labels say about taking them together
Codeine and paroxetine
Codeine's FDA label of December 22, 2025 names paroxetine in its drug interactions section; paroxetine's label does not name codeine itself but warns about its class (Opioids (opioid agonists)). The codeine label: “Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of …”
Check it at the source: the codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.); the paroxetine FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals Inc.).
What does the codeine label say about paroxetine?
Codeine label, drug interactionsRifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal … and evaluate patients at frequent intervals for signs and symptoms of respiratory depression or sedation. Paroxetine, fluoxetine, bupropion, quinidine.
Source: FDA drug label (Codeine sulfate), Hikma Pharmaceuticals USA Inc., effective December 22, 2025 (SPL set 010905f9-3bcb-4b50-9fe8-a3ad0010f14c), via openFDA; the full label on DailyMed
What does the paroxetine label say about codeine?
Paroxetine's label does not name codeine itself; it warns about its class (Opioids (opioid agonists)):
Paroxetine label, drug interactionsIf serotonin syndrome occurs, consider discontinuation of paroxetine tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ]. Examples other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort.
Paroxetine label, drug interactionsExamples Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, St. John’s Wort Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact The concurrent use of an antiplatelet agent or anticoagulant with Paroxetine HCL CR may potentiate the risk of bleeding.
Source: FDA drug label (Paroxetine), Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Codeine | Paroxetine | |
|---|---|---|
| Labeled for | Pain | Depression, Anxiety, Menopause symptoms |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.726 per tablet 30 mg tablet | $0.0611 per tablet 20 mg tablet |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once