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Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness, which can aid in the treatment of occasional sleep problems (insomnia).
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.
Ibuprofen PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains.
Ibuprofen PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.
Ibuprofen PM may also be used for purposes not listed in this medication guide.
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Ibuprofen PM just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.
You should not use this medicine if you are allergic to diphenhydramine or ibuprofen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:
heart disease, high blood pressure;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
a breathing problem, such as asthma, emphysema, or bronchitis;
liver or kidney disease;
glaucoma;
enlarged prostate or problems with urination; or
if you drink 3 or more alcoholic beverages per day.
This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor's advice if you are pregnant.
Diphenhydramine and ibuprofen may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.
This medicine is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving an antihistamine to a child. Death can occur from the misuse of antihistamines in very young children.
Use exactly as directed on the label, or as prescribed by your doctor. Do not take Ibuprofen PM in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. This medicine is usually taken only for a short time until your symptoms clear up.
Take this medicine with food or milk if it upsets your stomach.
Do not take this medicine for longer than 10 days without your doctor's advice.
Call your doctor if your symptoms do not improve, or if they get worse.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat.
Since this medicine is taken when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Ibuprofen PM can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin or other NSAIDs while you are taking Ibuprofen PM.
Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels.
Ask a doctor or pharmacist before using any cold, cough, allergy, or other sleep medicine. Antihistamines and NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or ibuprofen (or similar NSAIDs such as aspirin, naproxen, ketoprofen, and others).
Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using this medicine and call your doctor at once if you have:
the first sign of any skin rash, no matter how mild;
a light-headed feeling, like you might pass out;
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
drowsiness;
day-time drowsiness, dizziness, "hangover" feeling;
upset stomach, mild heartburn, diarrhea, constipation;
dry mouth, nose, or throat;
blurred vision;
mild itching or rash; or
ringing in your ears.
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.
Ask your doctor before taking Ibuprofen PM if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use Ibuprofen PM if you are also using any of the following drugs:
a blood thinner (warfarin, Coumadin, Jantoven);
a diuretic or "water pill"; or
diphenhydramine (Benadryl) used on the skin.
This list is not complete. Other drugs may interact with diphenhydramine and ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Ibu (www.drugs.com/mtm/ibuprofen-pm.html).
Note: This document contains side effect information about diphenhydramine / ibuprofen. Some of the dosage forms listed on this page may not apply to the brand name Ibuprofen PM.
For the ConsumerApplies to diphenhydramine / ibuprofen: oral capsule, 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:
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:
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 ProfessionalsApplies to diphenhydramine/ibuprofen: oral capsule, oral tablet
GeneralThe more commonly reported adverse effects include drowsiness and dyspepsia.
CardiovascularDiphenhydramine:
Frequency not reported: Hypotension, tachycardia, palpitations
Ibuprofen:
Common (1% to 10%): Peripheral edema
Uncommon (Less than 1%): Elevated blood pressure
Nervous systemThe CNS depressant effect of diphenhydramine parallels its plasma concentrations. The plasma concentration threshold for sedation is 30 to 42 ng/mL, and to cause mental impairment is 58 to 74 ng/mL. Dystonic reactions have been accompanied by dizziness, mental confusion, rigidity, lip and tongue protrusion, trismus, torticollis, and swallowing difficulties and generally resolve spontaneously. Delirium has been reported in elderly patients with mild dementia following a small oral dose of diphenhydramine.
The incidence of aseptic meningitis associated with ibuprofen is higher in patients with systemic lupus erythematosus and other connective tissue disease, although it has been reported in patients without such underlying disease states.
Diphenhydramine:
Very common (Greater than 10%): Drowsiness, sedation
Frequency not reported: Impaired motor skills, dystonic reactions, delirium
Ibuprofen:
Rare (less than 0.1%): Aseptic meningitis, paresthesias, and pseudotumor cerebri
Frequency not reported: Headache, drowsiness, dizziness
GastrointestinalMore serious gastrointestinal effects of ibuprofen are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, and pancreatitis. In addition, a case of ibuprofen-associated colitis has been reported.
The incidence of gastrointestinal blood loss with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.
Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effect. Ibuprofen should be used with caution in these patients.
Diphenhydramine:
Frequency not reported: Nausea, dry mouth
Ibuprofen:
Frequency not reported: Dyspepsia, nausea, diarrhea, abdominal pain, flatulence
RenalIbuprofen:
Frequency not reported: New or worsened renal insufficiency, nephrotic syndrome with and without renal failure, acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis
Ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.
A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
HypersensitivityMost commonly, hypersensitivity to diphenhydramine has manifested itself in patients receiving systemic drug after being sensitized to it by topical application. Sensitization with systemic administration has also been reported.
Patients who are at higher risk of hypersensitivity reactions to ibuprofen include those with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates, have also been reported.
Diphenhydramine:
Frequency not reported: Rash, pruritus, eczema, photosensitivity reactions
Ibuprofen:
Frequency not reported: Erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, anaphylactoid reactions
GenitourinaryDiphenhydramine:
Frequency not reported: Urinary retention, dysuria
HematologicReductions in serum hemoglobin concentrations are uncommon and are usually associated with occult gastrointestinal blood loss. Rare cases of ibuprofen-associated hemolytic anemia, autoimmune thrombocytopenia, and leukopenia have been reported.
Diphenhydramine:
Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis
Ibuprofen:
Frequency not reported: Platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, decreases in hemoglobin and hematocrit
OcularDiphenhydramine:
Frequency not reported: Blurred vision, diplopia, dry eyes
Ibuprofen:
Rare (less than 1%): Blurred vision
Frequency not reported: Scotomata, diplopia
DermatologicIbuprofen:
Frequency not reported: Maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, Stevens-Johnson syndrome, alopecia, toxic epidermal necrolysis, photosensitivity reactions
HepaticElevations in liver function tests three times normal values occur in less than 1% of patients treated with ibuprofen. Ibuprofen-induced hepatitis has been associated with a fatal outcome in some cases.
Ibuprofen:
Very common (over 10%): Elevations in liver function tests (15%)
Frequency not reported: Jaundice, hepatitis
MetabolicIbuprofen:
Frequency not reported: Hyponatremia and the Syndrome of Inappropriate Antidiuretic Hormone (SIADH), gynecomastia, hypoglycemia, metabolic acidosis
RespiratoryIbuprofen:
Frequency not reported: Noncardiogenic pulmonary edema
Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen and onset of symptoms was noted.
PsychiatricIbuprofen:
Frequency not reported: Depression
OtherIbuprofen:
Common (1% to 10%): Tinnitus
Frequency not reported: Vertigo
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Ibu (www.drugs.com/mtm/ibuprofen-pm.html).
July 31, 2020
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