Drug Profile

Pseudoephedrine (SUDAFED) is related both chemically and pharmacologically to the group of “speedlike” drugs that include amphetamines; the dangerous dietary supplement ephedra; ephedrine, which is a constituent of ephedra; and the banned nasal decongestant phenylpropanolamine (PPA). It is also used as a starting ingredient in the illegal manufacture of methamphetamine. Methamphetamine is a powerful, highly addictive stimulant. The side effects that arise from the use and abuse of methamphetamine include irritability, nervousness, insomnia, nausea, depression and brain damage[1].

Normal saline nasal wash or oxymetazoline nasal sprays offer safer and equally effective alternatives to pseudoephedrine.

Pseudoephedrine (as well as amphetamines, ephedra, ephedrine and PPA) can raise heart rate and blood pressure, which can lead to serious cardiovascular consequences.

PPA was banned by the Food and Drug Administration (FDA) because of an increased risk of hemorrhagic stroke in women.[2]

In addition to the possibility of raising heart rate and blood pressure, there have been reports in medical literature of a serious gastrointestinal (GI) side effect known as ischemic colitis. In this condition, blood flow to a section of the GI tract can be decreased, causing tissue death and symptoms such as fever, pain and bloody diarrhea.[3],[4] (Ischemic colitis led to the original market withdrawal of alosetron (LOTRONEX) and a new warning on the drug tegaserod (ZELNORM).)

In 2024, the Medicines and Healthcare products Regulatory Agency (agency in the U.K. similar to the FDA) issued a drug safety update warning that pseudoephedrine is associated with a very small number of reports of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome. The symptoms of these conditions include sudden severe headache or thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures and/or visual disturbances.[5]

Regulatory actions surrounding pseudoephedrine

2006: The FDA announced new legal requirements for the legal sale and purchase of drug products containing pseudoephedrine, ephedrine and phenylpropanolamine required by the Combat Methamphetamine Epidemic Act of 2005. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine. The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine. In addition, stores are required to keep personal information about purchasers for at least two years.[1]

2008: In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK equivalent of the FDA, announced that it will place tighter control on products containing pseudoephedrine and ephedrine. This change was a result of reports of misuse of these drugs in the manufacture of methylamphetamine (crystal meth).[6]