Promethazine Legal Information

Promethazine hydrochloride (promethazine HCl) is an antihistamine that helps with allergy symptoms, hives, and other medical conditions. In limited cases, healthcare professionals also prescribe the drug for:

• Sedation
• Motion sickness
• Pain relief, when taken with meperidine, an opioid pain medication

Promethazine is the generic version of several brand-name medications, namely Phenergan. The U.S. Food and Drug Administration (FDA) approved the drug in 1952.

This article shares essential information about promethazine, including side effects and risks. It also provides updates on research, news, and lawsuits surrounding the drug. You’ll also learn your legal rights and what to do if you develop an illness after using promethazine.

Drug and medical device manufacturers have a legal responsibility to ensure their products are safe to use and carry adequate warnings. If you have been harmed after using promethazine, Phenergan, or another drug—you have legal options. Contact a product liability attorney near you for next steps.

Who Owns and Markets Promethazine?

The French pharmaceutical company Rhone-Poulenc developed promethazine in the 1940s. The initial U.S. approval was granted to Wyeth Pharmaceuticals, which marketed the drug under the brand name Phenergan.

In 2009, Pfizer later acquired Wyeth. Currently, Sanofi holds rights to the brand name Phenergan in some markets.

What Does Promethazine Treat?

Promethazine is an antihistamine available only with a prescription. Doctors typically prescribe these drugs to help patients suffering from allergies. There are many other over-the-counter allergy medications. But prescription-strength antihistamines, such as promethazine, help treat other conditions as well.

Promethazine is a first-generation antihistamine with anticholinergic properties. First-generation antihistamines treat allergies by targeting histamine receptors in the spinal cord and brain.

You can take this medication orally, intramuscularly, or using rectal suppositories.

Doctors prescribe Phenergan (a brand name for promethazine) to treat the following conditions:

• A runny, stuffy nose from allergies or “hay fever”
• Mild allergic skin reactions
• Itchy, watery eyes from foods and inhaled allergies
• Rhinitis
• Conjunctivitis
• Allergic reactions to plasma or blood
• Motion sickness
• Dermographism (a type of hives called “skin writing”)
• Severe allergic reactions treated with epinephrine or other

Unlike over-the-counter allergy medicines, clinicians also prescribe promethazine for other purposes, such as:

• Sedation
• Control and prevention of vomiting and nausea
• Anxiety relief
• Assistance with sleep
• In combination with pain medications such as meperidine or codeine

Side Effects of Promethazine

As with most prescription drugs, promethazine has adverse side effects. Many of these are minor. But some can be life-threatening. Some patients should avoid taking this medication because of these potential health risks.

Common side effects of promethazine include:

• Dizziness
• Shortness of breath
• Nausea
• Vomiting
• Headache
• Drowsiness
• Sleepwalking
• Dry mouth
• Blurred vision
• Constipation

If any of these adverse effects persist, contact your healthcare provider. Generally, these adverse events pass after a few days. Other, more persistent side effects can be life-threatening.

Serious Side Effects of Promethazine

According to the FDA, the serious side effects of promethazine include:

• Seizures
• Hypotension (severe low blood pressure)
• Neuroleptic malignant syndrome (NMS)
• Serotonin syndrome
• Central nervous system (CNS) depression
• Severe respiratory depression
• Bone marrow depression
• Kidney disease

These side effects are so severe the FDA ordered the drug manufacturer to include black box warnings.

Who Should Avoid Taking Promethazine HCL

Certain patients should avoid promethazine. Your doctor may suggest an over-the-counter remedy instead. For example, if you’re taking tricyclic antidepressants, you should avoid promethazine.

You should also avoid taking this medication if you have an allergic reaction. There are many other antihistamines that can help with your symptoms.

Some of the other patients who should avoid this drug include:

• People taking monoamine oxidase inhibitors (MAOIs)
• Patients who take antidepressants (SSRIs)
• People with a seizure disorder
• Children under the age of 12
• Older adults
• Patients suffering from severe asthma
• People with a brain tumor
• Patients taking codeine

You should also avoid this drug if you take muscle relaxers or diuretics. Promethazine’s FDA fact sheet and safety information specifically indicates these contraindications. People with a lower body weight may be at an increased risk of a life-threatening reaction from taking promethazine.

You should also tell your healthcare provider if you are pregnant or breastfeeding.

FDA Alert Regarding Promethazine and Pediatric Patients

In April 2006, the FDA issued an alert notifying healthcare professionals and the public that doctors should not give promethazine to children less than two years old. The drug can cause breathing problems in pediatric patients.

Parents and caregivers should get a healthcare professional’s advice about giving promethazine to children over the age of two. Baxter Healthcare, which manufactured and sold a version of promethazine during this period, changed the labeling on all promethazine products to reflect these warnings.

Promethazine Litigation: Wyeth v. Levine

In Wyeth v. Levine (2009), musician Diana Levine lost her arm to amputation due to gangrene after being administered Phenergan, a drug made by Wyeth, via IV push. She sued Wyeth under Vermont state law, claiming the drug’s warning label was inadequate.

Wyeth argued that because the FDA had approved the label, federal law preempted state law claims. However, the U.S. Supreme Court ruled 6–3 in favor of Levine, holding that FDA approval does not shield drug manufacturers from liability under state law. The Court emphasized that manufacturers are responsible for their labels and can update them when new risks emerge, even without prior FDA approval.

This ruling had major implications for pharmaceutical litigation and consumer protection law.

February 2022: Florida Pharmacist Indicted on Promethazine Scheme

Over the last several years, the DEA and FDA have pursued several pharmacists for illegal sales of promethazine. One case involved pharmacist Adam Runsdorf of Boca Raton, Florida. The government charged Runsdorf and nine other defendants with the illicit manufacture and sale of counterfeit promethazine HCl cough syrup.

Runsdorf is the owner of Woodfield Pharmaceutical LLC. His company manufactured the counterfeit drugs in Houston, Texas.

May 2023: FDA Study on Patients Taking Promethazine and Flonase

In May 2023, the FDA published the results of a clinical study. It found a potential adverse drug interaction between promethazine and Flonase. The study found that females who took the two drugs in combination suffered from pneumonia. It also found that men who took both drugs experienced severe pain.

May 2023: Akorn Pharmaceuticals Voluntary Recalls Generic Promethazine HCL

In May 2023, Akorn Pharmaceuticals issued a voluntary recall of two generic versions of promethazine. These included promethazine HCl oral solution and the company’s promethazine HCl with codeine phosphate oral solution.

The company recalled more than 70 generic medications. The drugmaker didn’t provide specific reasons for why they issued the recall.

December 2023: FDA Requires Drugmaker to Update Warnings and Instructions for Promethazine

On December 27, 2023, the FDA ordered Sanofi to change its labeling instructions for injectable promethazine products. The new label requirements were for the company’s intravenous version of the drug.

According to the new product label instructions, healthcare professionals must dilute the drug before administering the injection. The FDA stated this would reduce the risks of irritation and tissue damage.

January 2024: Illegal Prescriptions for Promethazine Cough Syrup

In January, a federal judge sentenced a pharmacist to three years in federal prison. Zaman Alshafey was buying promethazine cough syrup from distributors and selling it to illegal drug dealers for huge profits.

The FDA and Department of Justice confirmed that Alshafey purchased more than $2.5 million of the drug. He earned more than $9 million in profits from selling the drug illegally.

When you take promethazine cough syrup in large doses, it can get you high. The street name used by drug users and dealers is “green drink” or “purple drink.”

The FDA and federal judge warned that pharmacists can only sell prescription drugs for the purposes on the drug’s label.

Hold Drug Manufacturers Accountable: Get Legal Help

Under product liability law, drug manufacturers have a duty to make their products as reasonably safe as possible. They must also inform the medical community and public of any known risks of their drugs.

If a manufacturer fails to issue these warnings, the courts may hold them legally responsible for patient injuries. Patients may be able to collect the following types of damages in their product liability lawsuit:

• Medical expenses
• Future medical bills
• Lost wages
• Lost future income
• Pain and suffering

If you or a loved one has experienced any dangerous symptoms while taking promethazine, contact a healthcare professional. You should also talk to an experienced attorney to learn your legal options.

FindLaw’s directory of product liability attorneys can connect you with qualified legal help in your area. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many law offices offer free case evaluations.