Take the pseudoephedrine packet or leaflet inside it, plus any remaining medicine, with you. Like all medicines, pseudoephedrine can cause side effects, although not everyone gets them.
Talk to a pharmacist or doctor if any of these side effects bother you or will not go away:. In rare cases, it's possible to have a serious allergic reaction anaphylaxis to pseudoephedrine. Pseudoephedrine is not recommended in pregnancy because it can reduce the blood flow in the placenta and to the baby. Pseudoephedrine is not recommended to take while you're breastfeeding. It passes into breast milk, but only in small amounts that are not harmful to the baby.
Pseudoephedrine can reduce the amount of milk you make, especially if you have not been breastfeeding for long.
If you're taking pseudoephedrine mixed with other medicines, you must check with a pharmacist or doctor whether it's safe to breastfeed. Some medicines and pseudoephedrine interfere with each other and increase the chances of you having side effects.
Pseudoephedrine is sometimes mixed with painkillers, such as cough and cold remedies. Before taking any other medicines, check the label to see if they contain aspirin, paracetamol or ibuprofen. There's very little information about taking herbal remedies and supplements with pseudoephedrine. Tell a doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.
Pseudoephedrine works by reducing the swelling of blood vessels in your nose. This helps mucus and air flow more freely in the cavities in your nose sinuses , helping you to breathe more easily. Pseudoephedrine starts to work in 15 to 30 minutes, but you should feel a lot better after 30 to 60 minutes. Pseudoephedrine can be taken for a few days, usually up to 5 to 7 days, for the short-term relief of a stuffy or blocked nose.
Decongestants should only be used for a short time, usually less than 10 days. Only take pseudoephedrine for longer than 10 days if a doctor has said it's OK. Pseudoephedrine works by narrowing the blood vessels in your nose, but it also narrows the blood vessels in other parts of your body.
If you have any heart problems or you're worried about this, speak to a pharmacist or doctor about a different treatment. It's a good idea to limit food and drink containing caffeine such as coffee, tea, cola and chocolate.
Caffeine can increase your risk of side effects, like feeling more restless or shaky and increasing your heartbeat. Pseudoephedrine does not affect any type of regular contraception, including the combined pill or emergency contraception. No, there's no evidence that pseudoephedrine affects fertility in men or women.
Pseudoephedrine does not affect your ability to drive or ride a bike. Page last reviewed: 22 August Next review due: 22 August Nasal sprays work faster than oral decongestants. However, be aware that using them for longer than recommended can actually make your congestion worse. Decongestants may cause mild side effects. Some possible side effects of oral and nasal decongestants include:.
Side effects that are specific to nasal sprays include:. More serious side effects that should be reported to your healthcare provider immediately include:. Note that stroke and intracranial bleeding may also occur with decongestant use. Caffeine may enhance the stimulant effect and worsen side effects related to stimulants, such as nervousness and trouble sleeping.
Looking to avoid getting the flu? Our free guide has everything you need to stay healthy this season. Sign up and get yours today. Institute for Quality and Efficiency in Health Care. Treating acute sinusitis. Updated October 18, The role of infection and antibiotics in chronic rhinosinusitis. Laryngoscope Investig Otolaryngol. Updated February 15, Updated August 15, Oxymetazoline nasal spray. Updated September 15, Nasal decongestants in monotherapy for the common cold.
Cochrane Database Syst Rev. Malone M, Kennedy TM. Review: side effects of some commonly used allergy medications decongestants, anti-leukotriene agents, antihistamines, steroids, and zinc and their safety in pregnancy. The mechanism of pseudoephedrine action is shown graphically in Figure 1. The mechanism of pseudoephedrine action. The principal mechanism by which pseudoephedrine achieves its effects is by displacing the norepinephrine noradrenaline from the storage vesicles in the presynaptic neurons; then, it is released into the neuronal synapse and becomes available to activate the alpha and beta postsynaptic adrenergic receptors.
Unlike epinephrine and norepinephrine, pseudoephedrine is active after oral administration and is easily absorbed from the gastrointestinal tract. The onset of action occurs after 30 min and after 1—4 h the drug reaches its maximum concentration in the blood. When using the extended-release formulation, this time is twice as long. The time the drug remains in the body depends on the pH of the urine; the value of the biological half-life t 0.
Selected pharmacokinetic properties of pseudoephedrine are presented in Table 1. 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.
However, these observations were made in women using mainly combined preparations, so the effect of other ingredients cannot be excluded. In the third trimester of pregnancy, PSE may cause reduced blood flow in the uteroplacental circulation, especially in women who smoke [ 20 ].
Another randomised population-based study conducted in Massachusetts, USA, involving live-born children without malformations, assessed the risk of preterm birth in relation to the use of decongestants in the upper respiratory tract.
The population-based retrospective cohort study was conducted between and on the basis of an interview. It was found that the use of pseudoephedrine in the second and third trimester of pregnancy for asthma, rhinitis, colds, nasal and sinus congestion, reduces the risk of preterm birth compared to women who have not used these drugs. These observations, however, had many limitations because the women participating in the study constituted a highly heterogeneous group in terms of age, race, education, social position, economic conditions, health status, and use of stimulants [ 21 ].
During lactation only small amounts, about 0. There are no conclusive results of studies on the efficacy and safety of PSE preparations in children. Most reports warn against their use in the therapy of children under 12 years of age, although a multicentre, double-blind, placebo-controlled randomised study by Gelotte et al.
The effects of PSE in elderly patients have not been specifically investigated. It is recommended to follow the adult dosage regimen, with special attention to kidney and liver function. If these organs are severely impaired, the drug should be used with caution. Overdosing in people over 60 years of age may cause hallucinations, CNS depression, seizures and death [ 18 , 19 ].
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 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 [ 9 , 23 ]. 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 [ 9 , 24 ].
Pseudoephedrine is recommended for the symptomatic treatment of obstruction in the nasal cavity, paranasal sinuses and the Eustachian tube. Other indications include vasomotor rhinitis and adjunctive therapy in allergic rhinitis and otitis media [ 9 , 18 , 19 ]. Contraindications to pseudoephedrine use are hypersensitivity to the drug, cardiovascular diseases hypertension and coronary artery disease , impaired function of organs responsible for elimination of the drug severe liver dysfunction, moderate or severe renal dysfunction , hyperthyroidism, narrow-angle glaucoma, benign prostatic hyperplasia, diabetes mellitus, mental agitation and treatment with monoamine oxidase inhibitors MAO inhibitors currently or in the last two weeks.
Contraindications also include physiological conditions such as pregnancy and lactation, and age under 2 years.
The extended-release form of the drug should not be used until the age of 12 years [ 18 , 19 ]. Although there are no reports of pseudoephedrine disturbing psychophysical performance, people driving motor vehicles should exercise caution and not use doses higher than recommended.
Studies evaluating the effect of this drug on daytime sleepiness and fatigue in patients suffering from perennial allergic rhinitis showed no positive or negative effect compared to placebo [ 25 ]. Pseudoephedrine is found as a hydrochloride or sulphate in doses ranging from 30 to mg in about 30 medicinal products. In combined preparations, it is most often compounded with antihistamines, analgesics and antitussive drugs; it comes in the form of plain, coated or extended-release tablets, capsules, syrup, powder or granules for oral fluid preparation.
The recommended dosage for adults is 60 mg 3—4 times a day or in the extended-release form— mg every 12 h. In Poland, there are many products containing pseudoephedrine with its content varying from 30 to mg [ 15 , 18 , 19 ]. The maximum permissible daily dose of pseudoephedrine is mg for an adult, mg for children aged 6—12 years and 60 mg for children aged 2—5 years [ 18 , 19 ]. Toxic effects may appear not only during the use of increased doses of the drug, but also in people who are particularly sensitive to the effects of sympathomimetics.
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 [ 9 , 18 , 19 ].
Pharmacotherapy is inevitably associated with the risk of drug-related complications; the most controversial is the effect of pseudoephedrine on blood pressure and its consequences. Some literature data suggest that oral sympathomimetic drugs may dangerously increase blood pressure, while others reassure that the danger is exaggerated.
One meta-analysis of randomised controlled trials showed that PSE at the recommended doses had no effect on systolic and diastolic blood pressure in healthy or controlled hypertensive patients. Systolic blood pressure increases by an average of 1 mm Hg and the heart rate increases by three beats per minute.
The effect of pseudoephedrine may induce non-convulsive epileptic states in predisposed individuals with pre-existing neurological disorders [ 15 , 30 ].
The risk of complications increases in patients with impaired renal and hepatic function. Unusual behaviour and myoclonic convulsions were observed in a year-old man suffering from renal failure, who took mg of PSE daily to treat rhinitis [ 15 ].
Severe agitation and disorientation can be expected in patients with phenylketonuria due to a disturbed metabolism of catecholamines [ 9 ]. Adverse effects of PSE can occur with both oral and intranasal administration after a single dose or after prolonged 5 days treatment, without affecting the dose and irrespective of the vascular condition and age.
A French study analysed adverse events with intranasal decongestants reported to regional pharmacovigilance centres by healthcare professionals. There were 22 episodes of arterial hypertension, 15 cases of convulsions and 4 cases of stroke after oral administration of drugs containing pseudoephedrine [ 6 ].
Less common adverse effects are skin reactions—cases of scarlet fever-like rash, erythematous spots, skin exfoliation of the palms and soles of the feet, and Baboon syndrome, clinically manifested by a rash mainly on the buttocks and within the larger folds of skin, have been reported [ 32 , 33 ].
When used in therapeutic doses, PSE may be responsible, especially in children, for the occurrence of pain and dizziness, increased heart rate, excessive agitation, insomnia and hallucinations [ 9 ].
In Wingert et al. Similar observations were made in by Rimsza and Newberry, who reviewed case files of unexpected deaths of children taking cold medications. PSE preparations should not be used in patients before the age of 12, and according to the French Society of Otorhinolaryngology, until the age of 15 [ 6 ]. On the pharmaceutical market, however, there are preparations allowing their administration to younger patients, e. The addictive potential of PSE is confirmed by the case of a year-old woman who abused it for its euphoric effect, increasing the doses over five years, using — mg daily.
Sudden discontinuation of the drug resulted in depressed mood, visual hallucinations and a feeling of fatigue [ 15 ]. Table 2 presents the adverse effects of pseudoephedrine and the incidence of some of them [ 18 , 19 , 34 , 35 ]. When several drugs are used concomitantly, an interaction may occur between them, as a result of which the final effect of some drugs changes.
The combination of pseudoephedrine with other sympathomimetic drugs and monoamine oxidase inhibitors MAO should be avoided. Inhibition of intra-neuronal NE breakdown in sympathetic nerves by MAO inhibitors leads to an increase in the amount of neuromediator released by pseudoephedrine, which may lead to hypertensive crisis and bradycardia.
This opens up your nasal passages and allows your sinuses to drain. As a result, your nasal passages are clearer and you breathe more easily. Most forms of Sudafed only contain pseudoephedrine. Any additional side effects, interactions, or warnings caused by naproxen sodium are not covered in this article.
Instead, they contain a different active ingredient called phenylephrine. All forms of Sudafed are taken by mouth. Below are dosage instructions for the different kinds of Sudafed. Like most drugs, Sudafed may cause side effects. Some of these side effects may go away as your body gets used to the medication. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. Also, before taking Sudafed, be sure to tell your doctor if you take any of the following medications:.
Sudafed is safe for many people. However, you should avoid it if you have certain health conditions, which may get worse if you take Sudafed. Before using Sudafed, be sure to tell your doctor if you have:. There are concerns of misuse with Sudafed because it can be used to make illegal methamphetamine, a very addictive stimulant.
However, Sudafed itself is not addictive.
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