This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
Brand Names: US
Advil Sinus Congestion & Pain [OTC]; Sudafed PE Head Congestion [OTC]
What is this drug used for?
- It is used to treat nose stuffiness.
- It is used to ease pain and fever.
- It is used to ease cold signs.
- It is used to treat the flu.
What do I need to tell my doctor BEFORE I take this drug?
For all patients taking this drug:
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
- If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
- If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
- If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
- If you are taking any of these drugs: Linezolid or methylene blue.
- If you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
- If you are having trouble getting pregnant or you are having your fertility checked.
- If you are pregnant, plan to become pregnant, or get pregnant while taking this drug. This drug may cause harm to an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this drug if your doctor has told you to. Do not take this drug if you are more than 30 weeks pregnant.
- If the patient is a child younger than 12 years of age. Do not give this drug to a child younger than 12 years of age.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- Do not take this drug for longer than you were told by your doctor.
- Talk with your doctor before you drink alcohol.
- If you smoke, talk with your doctor.
- If you have asthma, talk with your doctor. You may be more sensitive to this drug.
- This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.
- This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
- The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
- If you are taking aspirin to help prevent a heart attack, talk with your doctor.
- A severe and sometimes deadly reaction has happened with drugs like this one. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
- If you are 60 or older, use this drug with care. You could have more side effects.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
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.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Chest pain or pressure or a fast heartbeat.
- Any unexplained bruising or bleeding.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Very bad back pain.
- Feeling very tired or weak.
- Ringing in ears.
- Change in eyesight.
- Flu-like signs.
- Swollen gland.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe 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:
- Constipation, diarrhea, stomach pain, upset stomach, or throwing up.
- 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 your national health agency.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food. Take with food if it causes an upset stomach.
What do I do if I miss a dose?
- If you take this drug on a regular basis, take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
- Store at room temperature in a dry place. Do not store in a bathroom.
- Protect from heat.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer Information Use and Disclaimer
Last Reviewed Date
© 2023 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.