Pharmaceutical Name

Trade (marketing or proprietary) name: Afrinol^®, Cenafed^®, Children’s Sudafed Nasal Decongestant^®, Congestaclear^®, Efidac^®, Myfedrine^®, Pseudocot^®, Ridafed^®, Silfedrine^®, Sudafed 12/24 Hour^®, Sudafed Congestion^®, Sudodrin^®, SudoGest^®, Sudrine^®, Superfed^®, Suphedrin^®, and Allegra-D® (as a combination product containing Fexofenadine, Pseudoephedrine). For a list of the combination products, click here.

Generic (nonproprietary or active ingredient) name: Pseudoephedrine

Indication and Usage

Reason the product has been approved for sale on the market.

Pseudoephedrine is an over-the-counter medication used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Pseudoephedrine comes as a regular tablet, a 12-hour extended-release (long-acting) tablet, a 24-hour extended-release tablet, and a solution (liquid) to be taken by mouth. 

Pseudoephedrine comes alone and in combination with other medications. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using 2 or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

If your symptoms do not get better within 7 days or if you have a fever, stop taking pseudoephedrine and call your doctor.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Pseudoephedrine is structurally related to [ephedrine] but exerts a weaker effect on the sympathetic nervous system. Both drugs naturally occur in in ephedra plant which have a history of use in traditional Eastern medicine and were first researched in the west in 1889.

Other ingredients will vary based upon the brand. For example, the inactivated ingredients for Sudafed 12 hr are carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

Some versions contain multiple artificial dyes.

Drug and Food Interactions

Tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

Foods and drinks that contain large amounts of caffeine can make the side effects of pseudoephedrine worse.

Off-Label Use

Pseudoephedrine (PSE) is a drug with a long history of medical use; it is helpful in treating symptoms of the common cold and flu, sinusitis, asthma, and bronchitis. Due to its central nervous system (CNS) stimulant properties and structural similarity to amphetamine, it is also used for non-medical purposes. The substance is taken as an appetite reducer, an agent which eliminates drowsiness and fatigue, to improve concentration and as a doping agent. Due to its easier availability, it is sometimes used as a substitute for amphetamine or methamphetamine.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Tell your doctor if you have or have ever had high blood pressure, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision), diabetes, difficulty urinating (due to an enlarged prostate gland), or thyroid or heart disease. If you plan to take the 24-hour extended-release tablets, tell your doctor if you have had a narrowing or blockage of your digestive system.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Pseudoephedrine may cause: Restlessness, Nausea, Vomiting, Weakness, Headache, Nervousness, Dizziness, Difficulty sleeping, Stomach pain, Difficulty breathing, and Fast, pounding, or irregular heartbeat.

Specific Populations

Pregnancy

Pseudoephedrine (PSE) is present in numerous over-the-counter preparations and is taken by pregnant women. According to the US Food and Drug Administration (FDA), the drug belongs to category C, which means that animal studies have shown adverse effects on the foetus, although there are no controlled studies in pregnant women. It can therefore only be used in cases where the benefit to the mother outweighs the potential risk to the foetus [18]. Although there is insufficient evidence of a teratogenic effect of pseudoephedrine, the results of some studies suggest that it should be used with caution. It has been found that the use of preparations containing this compound in the first trimester of pregnancy may increase—almost twice (1.8 times) compared to the control group—the risk of congenital evisceration (a developmental defect of the abdominal wall with displacement of the intestines outside the abdominal cavity).

Other studies have found an increased chance of gastroschisis (an opening in the baby’s abdominal wall), small intestinal atresia (part of the small intestine is not fully developed) and hemifacial microsomia (part of the face is smaller than usual).

Pediatric

Nonprescription cough and cold combination products, including products that contain pseudoephedrine, can cause serious side effects or death in young children. Do not give nonprescription pseudoephedrine products to children younger than 4 years of age. If you give these products to children 4-11 years of age, use caution and follow the package directions carefully. Do not give pseudoephedrine extended-release tablets to children younger than 12 years of age.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

The drug reduces congestion of the upper respiratory tract mucosa, especially in the nose and paranasal sinuses (after oral administration), which in turn reduces the swelling, the amount of secretions and clears the nose. The sympathomimetic effect of pseudoephedrine may also improve the patency of the Eustachian tube and equalise the pressure in the middle ear during changes in atmospheric pressure while diving or flying by plane. The administration of 120 mg of pseudoephedrine to an adult at least 30 min before a flight may reduce earache. However, no similar effect has been observed in children. Pseudoephedrine is also effective in cases of urinary incontinence.

Similarly to other sympathomimetics, PSE stimulates the sympathetic system to fight-or-flight reactions—speeds up breathing, increases blood pressure, accelerates heart rate, narrows peripheral blood vessels, causes bronchodilatation, increases blood glucose levels, stimulates the CNS, as well as giving a sense of an energy surge and improving mood.

Overdose

Prolonged use of PSE, especially at short intervals, may reduce the effectiveness of the drug (tachyphylaxis) and increase the risk of toxic effects. As the result of an overdose, the symptoms of a sympathomimetic effect may vary. Sometimes there is a depressive effect on the CNS (sedative effect, apnoea, decreased ability to concentrate, cyanosis, coma and circulatory collapse), other times a stimulating effect (insomnia, hallucinations, tremors and convulsions). In extreme cases, death may occur. Symptoms of overdose also include headache, dizziness, anxiety, euphoria, tinnitus, blurred vision, ataxia, chest pain, tachycardia, palpitations, increased or decreased blood pressure, increased thirst, sweating, difficulty urinating, nausea and vomiting. In children, more frequently observed symptoms are dry mouth, wide and rigid pupils, hot flushes, fever, and digestive tract dysfunctions.

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for alternatives? Here are some products to research:

Pain FAQ

Do you struggle with pain and were recommended medications? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.

Cough FAQ

Do you struggle with coughing and were recommended medications? Click the image for prevention and treatment protocols + products to research for educated and empowered medical decisions.