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Does Promethazine Phenylephrine Codeine Interact with Ketoconazole?

CDI records a major classification for Promethazine Phenylephrine Codeine and Ketoconazole. The stored summary is: ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is achieved [see Warnings and Precautions (5.9) ] . Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This record was extracted from drug labeling through openFDA. NIH/NLM RxNorm is used for drug identities. The summary and severity classification are CDI's processed information, not a verbatim source quotation. Product, route, and patient circumstances matter.

Severity
Major
Ketoconazole Class
Azole Antifungal
Management
Close medical supervision required
Data Source
U.S. FDA via OpenFDA

What To Tell Your Doctor or Pharmacist

If you are taking Promethazine Phenylephrine Codeine and your doctor is considering prescribing Ketoconazole (or vice versa), make sure to:

  • Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
  • Ask whether the benefits of combining these medications outweigh the risks for your specific situation
  • Ask what symptoms to watch for that would indicate the interaction is causing problems
  • Ask how frequently you should be monitored while these are co-prescribed
  • Ask whether any dosage adjustments are needed
  • Never stop or change either medication without first consulting your healthcare provider
💊 Promethazine Phenylephrine Codeine(Promethazine And Phenylephrine Hcl, And Codeine Phosphate)+💊 Ketoconazole(T8 Keto Flush)

Severity & Interaction Details

⚠️
major
Use with caution — major interaction
Serious risk of clinically significant harm. Generally avoid; if used, monitor closely.
Severity scale
MinorContra
On record
Yes
Drug A class
—
Drug B class
Azole Antifungal
Source
FDA drug label - promethazine, phenylephrine, codeine

What this means in plain English

ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is achieved [see Warnings and Precautions (5.9) ] .

About Promethazine Phenylephrine Codeine and Ketoconazole

Ketoconazole is an Azole Antifungal. Ketoconazole is also sold under the brand name Ketodan. Both Promethazine Phenylephrine Codeine and Ketoconazole carry an FDA boxed warning — the agency's most serious safety designation.

Source and Limitations

This record was produced by automated extraction from drug-label information, including AI processing. The summary and mechanism are not verbatim FDA quotations. The drug profiles below may describe different formulations from the source label. Confirm the exact product and route with your pharmacist. This page does not establish independent clinical review.

📖 Source: FDA drug label - promethazine, phenylephrine, codeine

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How this information is prepared: CDI uses automated extraction, including AI, to summarize drug labeling from openFDA and includes separately identified curated-reference records. RxNorm helps identify medications; it does not verify interaction claims. Extracted summaries and CDI severity classifications can contain errors and are not verbatim FDA statements or independent clinical review. Maintained by CheckDrugInteractions.com. See our methodology or report a correction at support@checkdruginteractions.com.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.

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