The Current Status of Promethazine Availability
Promethazine is a first-generation antihistamine that was first approved for medical use in the United States in 1951 [1.3.4]. It belongs to the phenothiazine family of medications and is known for its antihistaminic, sedative, and antiemetic (anti-nausea) properties [1.3.3, 1.8.4]. Due to its long history, many patients and practitioners wonder about its current availability.
The simple answer is that promethazine itself has not been discontinued and is still available as a generic medication [1.3.2]. However, the confusion often stems from the discontinuation of specific brand-name versions and formulations.
Discontinued Brands and Formulations
- Phenergan: The well-known brand name Phenergan has been discontinued in the U.S. [1.12.2, 1.12.3]. The FDA determined that Phenergan tablets were not withdrawn from sale for reasons of safety or effectiveness, allowing for the approval of generic versions [1.4.4].
- Promethazine with Codeine Syrups: Several combination cough and cold syrups containing promethazine and codeine have been pulled from the market. For instance, the brand name Promethazine VC with Codeine was discontinued [1.2.1]. In January 2024, Pharmaceutical Associates, the sole supplier of a generic version of promethazine, phenylephrine, and codeine oral solution, also discontinued their product [1.2.2]. Years prior, in 2014, the company Actavis famously ceased production of its popular promethazine with codeine syrup due to widespread recreational abuse and glorification in popular culture [1.2.3, 1.4.2]. Despite this, generic promethazine/codeine formulations from other manufacturers remain available by prescription [1.3.1].
Available Promethazine Formulations
Generic promethazine remains widely accessible and is covered by most Medicare and insurance plans [1.3.2]. It is available in several forms to suit different clinical needs [1.13.1, 1.13.3]:
- Oral Tablets: Available in strengths of 12.5 mg, 25 mg, and 50 mg.
- Oral Solution/Syrup: Typically comes in a concentration of 6.25 mg/5 mL.
- Rectal Suppositories: Available in 12.5 mg, 25 mg, and 50 mg strengths, which are useful for patients who are actively vomiting.
- Injectable Solution: Administered by healthcare professionals in a clinical setting.
Pharmacology and Clinical Use of Promethazine
Promethazine functions by blocking several types of receptors in the body. Its primary action is blocking H1 histamine receptors, which accounts for its anti-allergy effects [1.11.3]. It also has strong anticholinergic (blocking acetylcholine) and anti-dopaminergic effects, which contribute to its anti-nausea and sedative properties [1.8.3, 1.11.1].
FDA-Approved Indications:
- Allergic Conditions: Used for hay fever, allergic conjunctivitis, and uncomplicated skin reactions like hives [1.9.2].
- Nausea and Vomiting: Effective for managing nausea and vomiting associated with surgery, anesthesia, or chemotherapy [1.9.2, 1.11.1].
- Motion Sickness: Can prevent and treat symptoms of motion sickness [1.9.2].
- Sedation: Used for pre-operative, post-operative, or obstetric sedation to relieve apprehension and induce a light sleep [1.9.2, 1.13.3].
Occasionally, it is used off-label for anxiety, particularly in hospital settings before surgery, due to its sedative effects [1.9.1].
Important Safety Information and Side Effects
Promethazine carries significant warnings. The FDA has issued a boxed warning against its use in pediatric patients under 2 years of age due to the risk of potentially fatal respiratory depression [1.7.1, 1.7.2]. Caution is advised for children 2 years and older, with the lowest effective dose recommended [1.7.1].
Common side effects include:
- Drowsiness and sedation (the most prominent effect) [1.7.1]
- Dizziness and confusion [1.8.3]
- Dry mouth [1.8.1]
- Blurred vision [1.8.3]
Elderly patients may be more sensitive to these side effects, particularly confusion and severe drowsiness, which increases the risk of falls [1.8.1, 1.8.2]. Because of its effects, patients are warned against driving or operating heavy machinery until they know how the medication affects them [1.7.1].
Comparison with Alternatives
Depending on the intended use, several alternatives to promethazine are available.
| Feature | Promethazine | Diphenhydramine (Benadryl) | Ondansetron (Zofran) |
|---|---|---|---|
| Primary Class | Phenothiazine Antihistamine [1.8.4] | First-Generation Antihistamine [1.10.1] | Serotonin 5-HT3 Antagonist [1.11.2] |
| Main Uses | Allergies, Nausea/Vomiting, Sedation, Motion Sickness [1.9.2] | Allergies, Insomnia, Motion Sickness [1.10.2] | Nausea/Vomiting (especially post-op & chemo) [1.11.1] |
| Sedation Level | High [1.7.1] | High [1.10.2] | Low to None [1.11.3] |
| Prescription? | Prescription Only [1.5.1] | Over-the-Counter (OTC) & Rx [1.10.2] | Prescription Only [1.11.2] |
| Age Restriction | Do not use in children <2 years [1.7.1] | Varies by product, consult label | Can be used in children (age varies by form) [1.11.2] |
| Half-Life | ~16 hours [1.10.2] | ~9.3 hours [1.10.2] | Shorter than promethazine |
For allergies, newer, non-drowsy antihistamines like Cetirizine (Zyrtec) and Loratadine (Claritin) are often preferred [1.6.4]. For nausea, Ondansetron (Zofran) is a common alternative, especially for post-operative or chemotherapy-induced nausea, as it works on different brain receptors and causes less sedation [1.11.1, 1.11.3].
Conclusion
To summarize, the core question of 'Has promethazine been discontinued?' can be answered with a 'no, but with caveats.' While iconic brand names like Phenergan and certain combination syrups are off the market, the active ingredient, promethazine, is still manufactured and prescribed in its generic form across various dosage types [1.12.2]. It remains an effective medication for allergies, nausea, and sedation, but its use requires caution due to a significant side effect profile, especially its potent sedative effects and the serious risk of respiratory depression in young children [1.7.1]. Patients should always consult a healthcare professional to determine if promethazine or one of its many alternatives is the most appropriate treatment for their condition.
For more information on the risks associated with this medication, consult the FDA Drug Safety Communication. [1.7.4]
