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Promethazine FDA Alerts

The FDA Alerts below may be specifically about promethazine or relate to a group or class of drugs which include promethazine.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for promethazine

Promethazine Hydrochloride Injection

FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.

[09/16/2009 - Information for Healthcare Professionals - FDA]
[09/16/2009 - News Release - FDA]


Promethazine HCl (marketed as Phenergan and generic products)

[Posted 04/25/2006] FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.

[April 25, 2006 - Drug Information Page - FDA]

Phenergan (promethazine hydrochloride)

FDA and Wyeth notified healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan. Phenergan is contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression including fatalities, have been reported with use of Phenergan in pediatric patients less than two years of age. Caution should also be exercised when administering Phenergan to pediatric patients two years of age and older.

[January 21, 2005 Letter - Wyeth]
[December, 2004 Revised Label - Wyeth]

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