Promethazine hydrochloride (HCl) is an antihistamine marketed under the brand names Phenergan and Pentazine. Promethazine HCl was approved by the U.S. Food and Drug Administration (FDA) in 1951, and is used to treat the following conditions:
Promethazine is also used during medical treatment for sedation, prevention and control of nausea and vomiting, anxiety relief, assistance with sleep, and in combination with pain medications.
Promethazine - FDA Alert
In April 2006, the FDA issued an alert notifying healthcare professionals and the public that promethazine HCl shouldn’t be given to children less than two years old, because of possible breathing problems. Parents and caregivers should get a healthcare professional's advice about giving promethazine in any form to children age two and older. The labeling on all promethazine HCl products (both brand name and generic) has been changed to reflect these strengthened warnings.
Who Should Not Use Promethazine?
Promethazine should not be given to:
Promethazine Health Risks
Promethazine had been linked to a number of health risks, including severe drowsiness, breathing problems, risk of seizures, and more.
Severe drowsiness and reduced mental alertness
Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may worsen if promethazine is taken with alcohol or other central nervous system (CNS) depressants, such as sedatives, pain medicines, tranquilizers, or certain medicines used to treat depression.
Serious breathing problems
Promethazine should not be used in patients with poor lung function, such as chronic obstructive lung disease or breathing problems while sleeping (sleep apnea).
Increased risk of seizures
Promethazine should be used with caution in patients with seizures, or patients who are on other medicines which may also increase the risk of seizures.
Bone-marrow problems and blood cell production
Promethazine shouldn’t be used in patients with bone-marrow problems, or used with other drugs that affect the bone marrow's production of blood cells.
Neuroleptic malignant syndrome
This potentially deadly syndrome includes symptoms such as fever, muscle rigidity, mental changes, changes in pulse or blood pressure, fast heartbeat, increased sweating or irregular heart rhythm.
Promethazine Side Effects
The most common side effects associated with promethazine use include:
Increased excitability or abnormal movements may occur after one dose of promethazine. If they do, consult your healthcare professional about using another medicine.
What Should I Tell My Healthcare Professional?
Before you start taking promethazine, tell your healthcare professional if you have:
You should also tell you doctor if you drink alcohol or are trying to become pregnant, are already pregnant, or are breast-feeding.
Are There Any Interactions With Drugs or Foods?
Promethazine and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines, vitamins, and herbal supplements you take, particularly:
Promethazine - Getting Legal Help
Under product liability law, Drug manufacturers have a duty to make their products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with their drugs. If a manufacturer fails to do so, it can be held legally responsible for patient injuries that result from inadequate warnings or the unreasonably dangerous nature of the drug
If you or a loved one has experienced any dangerous symptoms while taking promethazine, you should first contact your doctor or treating healthcare professional. You may also be in your best interests to meet with an experienced products liability or medical malpractice attorney to learn more about filing a lawsuit for any injuries you’ve suffered.
Contact a qualified product liability attorney to make sure your rights are protected.