Sudafed pe side effects

Sudafed PE Pressure + Pain Side Effects

Generic Name: acetaminophen / phenylephrine

Medically reviewed by Drugs.com. Last updated on Aug 26, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • Reviews
  • More

Note: This document contains side effect information about acetaminophen / phenylephrine. Some of the dosage forms listed on this page may not apply to the brand name Sudafed PE Pressure + Pain.

For the Consumer

Applies to acetaminophen / phenylephrine: oral capsule, oral packet, oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to acetaminophen/phenylephrine: oral capsule, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet effervescent

Dermatologic

Very rare (less than 0.01%): Serious skin reactions

Frequency not reported: Skin rash

Hematologic

Frequency not reported: Thrombocytopenia, leukopenia, pancytopenia, neutropenia, agranulocytosis

Reports of blood dyscrasias are not necessarily causally related to acetaminophen.

Gastrointestinal

Frequency not reported: Abdominal discomfort, nausea, vomiting

Genitourinary

Frequency not reported: Urinary retention (especially in males)

Hypersensitivity

Frequency not reported: Hypersensitivity

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Sudafed PE Sinus Pressure + Pain (acetaminophen / phenylephrine)

  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • En Español
  • 1 Review
  • Drug class: upper respiratory combinations
  • FDA Alerts (2)

Consumer resources

  • Sudafed PE Sinus Headache
  • Sudafed PE Sinus Headache Max

Related treatment guides

  • Nasal Congestion
  • Sinus Symptoms

SUDAFED PE Pressure Plus Pain

acetaminophen and phenylephrine hydrochloride tablet, film coated

  • CareOne Sinus plus Headache (tablet, film coated)
  • COLTALIN-ND (tablet)
  • Contac Cold and Flu Day (kit)
  • D TIME SINUS (capsule, liquid filled)
  • Day Relief Sinus PE (capsule, liquid filled)
  • Day Time Sinus Pain Reliever, Nasal Decongestant (capsule, liquid filled)
  • Defensolito (tablet, chewable)
  • Good Sense Sinus plus Headache (tablet, film coated)
  • Green Guard Advanced Sinus Relief (tablet)
  • Humana Pharmacy Sinus Relief (tablet, film coated)
  • Mapap Sinus Congestion and Pain Maximum Strength (tablet, film coated)
  • Nasal Decongestant PE and Pain Relief Maximum Strength (tablet)
  • Non-Drowsy Sinus Daytime (tablet, film coated)
  • Pain Relief Non Drowsy Daytime (tablet)
  • Panadol Cold and Flu NonDrowsy (tablet, film coated)
  • Pressure and Pain PE (tablet, coated)
  • ROBITUSSIN PEAK COLD NASAL RELIEF (tablet)
  • shoprite sinus congestion and pain (tablet, film coated)
  • SINE OFF MAXIMUM STRENGTH (tablet, coated)
  • Sinus and Congestion Relief Daytime (capsule, liquid filled)
  • Sinus and Headache (tablet, film coated)
  • Sinus and Headache Daytime Non-Drowsy (tablet, film coated)
  • Sinus and Headache Daytime, Non-Drowsy (tablet, film coated)
  • Sinus Congestion and Pain Daytime (tablet, film coated)
  • Sinus Congestion and Pain Daytime Non-Drowsy (tablet, film coated)
  • Sinus Congestion and Pain Daytime, Non-drowsy (tablet)
  • Sinus Congestion and Pain Relief Non-Drowsy (tablet, film coated)
  • Sinus Congestion and Pain Relief Non-Drowsy, Daytime (tablet)
  • Sinus Daytime (capsule, liquid filled)
  • Sinus Headache and Pain Day, Non-drowsy (tablet, film coated)
  • Sinus Headache PE Non- Drowsy Maximum Strength (tablet)
  • Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy (tablet)
  • Sinus PE Pressure plus Pain MAXIMUM STRENGTH (tablet)
  • Sinus Pressure and Pain Maximum Strength (tablet)
  • Sinus Pressure and Pain PE Maximum Strength (tablet)
  • Sinus Pressure Pain Maximum Strength, Non-Drowsy (tablet)
  • Sinus Relief Congestion and Pain Daytime (tablet)
  • sinus relief non drowsy (tablet, film coated)
  • Sinus Relief Non-Drowsy Daytime (capsule, liquid filled)
  • smart sense sinus and headache (tablet, film coated)
  • Suphedrine PE Pressure plus Pain Maximum Strength, Non-Drowsy (tablet)
  • TYLENOL SINUS PLUS HEADACHE DAY (tablet, film coated)
  • Vicks QlearQuil Daytime Sinus and Congestion (capsule, liquid filled)
  • Vicks Sinex Severe Pressure and Pain (capsule, liquid filled)
  • Wal-Phed PE Maximum Strength, Non-Drowsy (tablet)
  • Wal-Phed PE Pressure plus Pain Maximum Strength Non-Drowsy (tablet)

Medicine cabinet basics: Facts about pain relievers

If you took a long run and then woke up the next day with a throbbing ankle, what would you take to relieve the pain? What do you give a feverish toddler? When you have flu-related aches and pains with a stuffy nose, do you take ibuprofen or acetaminophen?

The shelves of drug stores are lined with options. Some pain relievers double as sleep aids, others work as decongestants. There are generics, name brands, pills and liquids in a variety of colors. Some are made specifically for children and others treat arthritis pain or menstrual cramps. How do you make a safe and effective choice?

We asked Danielle Mackey, pharmacist and program manager of investigational drug services at Providence Health & Services in Portland, to help us parse the facts.

Ibuprofen

Ibuprofen is one of a group of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). It can be used to relieve the following:

  • Mild to moderate pain, such as a toothache, migraine or achy muscles
  • Fever – for example, when you have the flu
  • Pain and inflammation (redness and swelling) caused by rheumatic diseases (conditions that affect the joints) and musculoskeletal disorders (conditions that affect the bones and muscles)
  • Pain and swelling caused by sprains and strains, such as sports injuries

Generic ibuprofen contains one ingredient: ibuprofen. However, many brand-name products that contain ibuprofen may include other active ingredients. For example, Sudafed® contains both pseudoephedrine to relieve congestion, and ibuprofen to reduce fever. Advil® and Motrin® are brand names for generic ibuprofen, but they also may contain other medications.

Mackey says it’s important to look at the active ingredients in over-the-counter medications, especially when taking them with prescription medications. “A combination of products can be dangerous,” she says.

Side effects and warnings
Just because ibuprofen is readily available without a prescription doesn’t mean that the drug is free of side effects or potential health risks. Taken on an empty stomach, even one ibuprofen tablet can cause nausea, upset stomach or vomiting.

Other side effects may include the following:

  • Mild heartburn
  • Bloating, gas, diarrhea or constipation
  • Dizziness
  • Headache
  • Nervousness
  • Mild itching or rash
  • Ringing in the ears

Ibuprofen has been proven to increase the risk of heart attack and stroke. Some people should avoid using ibuprofen altogether. Talk to your primary care provider before taking ibuprofen if you:

  • Are over age 60
  • Are pregnant or nursing
  • Have three or more drinks of alcohol every day
  • Have bleeding problems
  • Have liver or kidney disease
  • Have heart disease
  • Take a medicine to thin the blood, such as warfarin
  • Take a medicine for high blood pressure

Acetaminophen

Acetaminophen is a common nonprescription drug used for relieving mild-to-moderate pain and fever. It’s often combined with other active ingredients in medicines that treat allergy, cough, colds, flu, menstrual pain and sleeplessness. As a prescription medicine, acetaminophen may be combined with opioid narcotics for the treatment of moderate to severe pain.

Like ibuprofen, acetaminophen is widely available in a variety of over-the-counter medications. Here are just a few of the common brand-name products that contain acetaminophen:

  • Tylenol® products
  • Actifed®
  • Alka-Seltzer Plus®
  • Excedrin®
  • Midol®
  • Mucinex®
  • Nyquil®

Don’t take too much
Acetaminophen can cause liver damage. When taking any over-the-counter product, prescription medication or combination of the two, it’s important to check the active ingredients to make sure you don’t take more than one medicine containing acetaminophen. On prescription medicines, the label may spell out acetaminophen or have a shortened version of it, such as “APAP,” “acet,” “acetamin” or “acetaminoph.” If you aren’t sure whether or not your medicine contains acetaminophen, ask your health care professional for help.

“Know what strength you need,” says Mackey. “And consider the cumulative amount for one day.”

Also be aware of these important points:

  • How many hours you must wait between doses
  • How many times you can take it each day
  • When you should not take it
  • When to talk to your health care professional

Children and medications

Parents should use caution when giving children over-the-counter medications to ease pain or a fever. Ibuprofen should not be given to children younger than 6 months old. Don’t confuse infant liquid drops and children’s “suspension” liquid. Infant drops are much more concentrated. Always read the label on the product and ask your pediatrician if the medication is safe for your child before administering it.

It’s important to know the appropriate dosage. The correct dosage may depend on these factors:

  • The child’s age
  • The child’s weight
  • The strength of the medications

Never give a child aspirin. In fact, the American Academy of Pediatrics recommends that children under the age of 19 should not be given aspirin, because of its link to a rare childhood disorder called Reye’s syndrome. No medicine that is sold as suitable for children will contain aspirin.

If you have questions about over-the-counter or prescription medicines for your child, talk to your pediatrician or pharmacist. Find a Providence provider here.

Sudafed

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/13/2018

Sudafed (pseudoephedrine HCI) is a decongestant prescribed for the temporary relief of nasal congestion due to the common cold, hay fever, and sinus congestion. Sudafed is available as a generic drug. Common side effects of Sudafed include:

Sudafed usual dose is one tablet every 12 hours. Sudafed drug interactions include monoamine oxidase inhibitors or MAOIs (for example, isocarboxazid ), serotonin and norepinephrine reuptake inhibitors (for example, venlafaxine ), bronchodilators (for example, albuterol ), blood pressure medications (such as beta blockers ) and calcium channel blockers ). Tell your doctor if you are pregnant or plan to become pregnant while using Sudafed; it is unknown if Sudafed will harm a fetus. Sudafed passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Sudafed Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pseudoephedrine / triprolidine Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 21, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • Reviews
  • More

Applies to pseudoephedrine / triprolidine: oral liquid, oral tablet

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to pseudoephedrine/triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release

Nervous system

Rare (less than 0.1%): Hallucinations

Frequency not reported: Central nervous system depression or excitation, drowsiness, sleep disturbance

Cardiovascular

Frequency not reported: Tachycardia

Frequency not reported: Dry mouth, nose and throat

Frequency not reported: Urinary retention

Frequency not reported: Skin rashes (with or without irritation)

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

More about pseudoephedrine / triprolidine

  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • En Español
  • 16 Reviews
  • Drug class: upper respiratory combinations
  • Pseudoephedrine and triprolidine
  • Triprolidine and Pseudoephedrine Tablets
  • Triprolidine and Pseudoephedrine Liquid

Other brands: Actifed, Aprodine, A-Phedrin, Allerfrim, … +11 more

  • Allergic Rhinitis
  • Cold Symptoms

If you are looking for a combination product to help with the symptoms of congested sinuses, then you could try Sudafed sinus pressure and pain tablets, containing the painkiller ibuprofen 200mg and a decongestant pseudoephedrine 30mg.

Our resident pharmacist Rita Ghelani offers her expert advice on how Sudafed sinus pressure and pain tablets help with the symptoms of cold and blocked sinuses, how to they work and the possible side effects.

What are Sudafed sinus pressure and pain tablets used for?

Relieving symptoms of colds and flu, such as headache, sore throat, aches and pains, fever, blocked nose and sinus congestion and pain.

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How do Sudafed sinus pressure and pain tablets work?

Sudafed sinus pressure and pain tablets contain painkiller ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). It relieves mild to moderate pain, inflammation and fever.

Ibuprofen works by blocking the action of an enzyme in the body called cyclo-oxygenase (COX). COX is involved in making substances called prostaglandins, in response to injury and in certain diseases and conditions. The prostaglandins cause pain, swelling and inflammation. Ibuprofen reduces inflammation and pain by reducing the production of these prostaglandins.

Ibuprofen brings down a fever by reducing the production of prostaglandins in the brain. Fever is associated with an increase in prostaglandins in the brain, which cause the body temperature to increase.

Pseudoephedrine works by causing the blood vessels in the linings of the nasal passages and sinuses to contract and narrow. This decreases blood flow into the linings of the nose and sinuses, which reduces the feeling of congestion and also reduces the production of mucus.

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Dosage instructions for Sudafed sinus pressure and pain tablets

  • Adults and adolescents over 12 years of age should take one or two tablets up to three times a day as needed to relieve symptoms.
  • Leave at least four hours between doses.
  • Do not take more than six tablets in 24 hours.
  • The tablets should preferably be taken with or after food.
  • This medicine should be used for the shortest possible time to relieve symptoms. If your symptoms persist despite treatment or get worse, get medical advice from your doctor or pharmacist. Do not use this medicine for more than 10 days without consulting a doctor.

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Sudafed sinus pressure and pain tablets should not be taken by

  • Children under 12 years of age.
  • People who have ever had an allergic reaction after taking aspirin or other NSAIDs such as diclofenac (for example an asthma attack, itchy rash, nasal inflammation (rhinitis) or swelling of the lips, tongue and throat).
  • People with an active peptic ulcer or bleeding in the gut; those who’ve had two or more episodes of this in the past; and people who have ever experienced bleeding or perforation in the gut as a result of taking an NSAID.
  • People with severe kidney failure or liver failure.
  • People with severe heart failure, heart disease or high blood pressure (hypertension).
  • People with an overactive thyroid gland (hyperthyroidism).
  • People with a tumour of the adrenal gland (phaeochromocytoma).
  • People with diabetes.
  • People with closed angle glaucoma.
  • Men with an enlarged prostate gland.
  • People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.
  • People taking any other NSAID painkillers, including COX-2 inhibitors such as celecoxib.
  • Ibuprofen is not recommended for women who are trying to get pregnant because it can temporarily reduce female fertility.

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Sudafed sinus pressure and pain tablets should be used with caution by

  • Elderly people.
  • People with a history of asthma or allergies.
  • People with a history of disorders affecting the stomach or intestines, such as ulceration or bleeding, or inflammatory bowel disease such as Crohn’s disease or ulcerative colitis.
  • People with kidney or liver problems.
  • People with a history of heart disease or stroke.
  • Smokers.
  • People with high cholesterol levels.
  • People with blood circulation problems such as Raynaud’s disease.
  • People with blood clotting problems or taking anticoagulant medicines.
  • People with diseases affecting connective tissue, such as systemic lupus erythematosus.

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Is it safe to take Sudafed sinus pressure and pain tablets if pregnant?

Sudafed sinus pressure and pain is not recommended for use during pregnancy, particularly in the third trimester. In the third trimester the ibuprofen may delay labour, increase the length of labour and cause complications in the new-born baby. Get advice from your doctor, pharmacist or midwife if you need to treat cold and flu symptoms while you are pregnant.

Is it safe to take Sudafed sinus pressure and pain tablets if breastfeeding?

Sudafed sinus pressure and pain is best avoided by mothers who are breastfeeding, because decongestants such as pseudoephedrine can temporarily decrease the production of breast milk. Ask your doctor or pharmacist for further advice.

Possible side effects of Sudafed sinus pressure and pain tablets

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that may be associated with Sudafed sinus pressure and pain. Just because a side effect is stated here doesn’t mean that all people using this medicine will experience that or any side effect.

  • Disturbances of the gut such as nausea, vomiting, diarrhoea, indigestion or abdominal pain. These can mainly be avoided by taking the medicine with food or milk.
  • Headache.
  • Skin rashes.
  • Dry mouth.
  • Dizziness.
  • Increased heart rate (tachycardia).
  • Palpitations.
  • Ulceration or bleeding in the stomach or intestines. This is more likely in elderly people. If any signs of bleeding from the stomach or bowels are experienced, such as vomiting blood and/or passing black/tarry/bloodstained stools, you should stop taking this medicine and consult your doctor immediately.
  • Liver or kidney disorders.
  • Difficulty sleeping (insomnia).
  • Difficulty passing urine (urinary retention).
  • Anxiety, restlessness or tremor.
  • Seeing or hearing things that aren’t really there (hallucinations).
  • Allergic reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat or tongue (angioedema), itchy blistering rash or anaphylactic shock. Stop taking this medicine and get immediate medical advice if you think you’ve had an allergic reaction.

For more information about the possible side effects of Sudafed, read the information provided with the medicine or talk to your doctor or pharmacist. You can find a copy of this here

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If you think you have experienced a side effect after taking Sudafed sinus pressure and pain tablets you can report using the yellow card website.

Can I take Sudafed sinus pressure and pain tablets with other medicines?

If you’re already taking any other medicines, check with your pharmacist before taking Sudafed sinus pressure and pain tablets.

Painkillers with Sudafed sinus pressure and pain tablets

Do not take these tablets with other medicines that contain ibuprofen, as this can easily result in exceeding the maximum recommended daily dose of ibuprofen. Many cold and flu remedies and over-the-counter painkillers contain ibuprofen, so be sure to check the ingredients of any other medicines before taking them with this one. Ask your pharmacist for further advice. It is okay to take paracetamol with this medicine if needed.

Don’t take Sudafed sinus pressure and pain tablets with painkilling doses of aspirin or any other oral NSAID, for example diclofenac or naproxen, as this increases the risk of side effects on the stomach and intestines. People taking selective inhibitors of COX-2 such as celecoxib or etoricoxib should avoid this medicine for the same reason.

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Other cold & flu remedies with Sudafed sinus pressure and pain tablets

You should not use this medicine with other cough, cold and flu or decongestant medicines, unless they have been specifically recommended by your pharmacist.

Other medicine interactions with Sudafed sinus pressure and pain tablets

Avoid taking this medicine if you’re already taking any of the following medicines because the combination may increase your blood pressure:

  • appetite suppressants
  • amphetamine-like stimulants, including methylphenidate, dexamfetamine and modafinil
  • other decongestants (often found in other non-prescription cough and cold remedies)
  • the antibiotic linezolid
  • tricyclic antidepressants, such as amitriptyline.

If you’re taking medicines for high blood pressure you shouldn’t take this medicine as well, because the pseudoephedrine may make your blood pressure medicine less effective.

You’re more at risk of ulceration or bleeding in your gut if you take ibuprofen with corticosteroids such as prednisolone. There may also be an increased risk of bleeding in the gut if you take ibuprofen with other medicines that can increase the risk of bleeding, such as those below. If you’re taking one of these, you shouldn’t take Sudafed sinus pressure and pain tablets unless advised to by your doctor:

  • anti-blood-clotting (anticoagulant) medicines such as warfarin, dabigatran, apixaban, edoxaban, rivaroxaban, heparin and low molecular weight heparins such as enoxaparin
  • antiplatelet medicines to reduce the risk of blood clots or ‘thin the blood’, such as dipyridamole, clopidogrel, prasugrel, low-dose aspirin
  • erlotinib
  • ginko biloba (a herbal remedy)
  • SSRI antidepressants, such as fluoxetine, paroxetine, citalopram
  • venlafaxine.

There may be an increased risk of side effects on the kidneys if ibuprofen is taken in combination with any of the following medicines:

  • ACE inhibitors, such as enalapril
  • ciclosporin
  • diuretics, such as furosemide (ibuprofen may also reduce the effectiveness of diuretic medicines)
  • tacrolimus.

Ibuprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines:

  • digoxin
  • lithium
  • methotrexate.

If ibuprofen is taken with quinolone antibiotics, such as ciprofloxacin or norfloxacin there may be an increased risk of seizures (fits), particularly if you suffer from epilepsy.

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Last updated 21.11.2019

Rita Ghelani (BPharm, MRPharmS) Pharmacist A UK registered practising pharmacist with over 20 years’ experience, Rita is a member of the medical journalists’ association (MJA) and has a wealth of experience in community pharmacy.

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