Diphenhydramine-Ibuprofen

Diphenhydramine-Ibuprofen is an over-the-counter (OTC) medication used for occasional sleeplessness associated with mild-to-moderate pain. 

• Diphenhydramine-Ibuprofen is available under the following different brand names: Advil PM

Common side effects of Diphenhydramine-Ibuprofen include:

• Drowsiness.
• Day-time drowsiness, dizziness, and a "hangover" feeling.
• Upset stomach, heartburn, diarrhea, and constipation.
• Dry mouth, nose, or throat.
• Blurred vision.
• Mild itching or rash; or
• Ringing in your ears.

Serious side effects of Diphenhydramine-Ibuprofen include:

• Any skin rash, no matter how mild.
• A light-headed feeling,
• Signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
• Kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• 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).

Rare side effects of Diphenhydramine-Ibuprofen include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Caplet

• 25 mg/200 mg
• 38 mg/200 mg

Pain

Adult dosage

• 2 caplets orally at bedtime; not to exceed 2 caplets/24 hours

Pediatric dosage

• Children below 12 years: Safety and efficacy not established
• Children above 12 years: 2 caplets orally at bedtime; not to exceed 2 caplets/24 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Diphenhydramine-Ibuprofen has severe interactions with the following drug
  • eliglustat
• Diphenhydramine-Ibuprofen has serious interactions with at least 40 other drugs.
• Diphenhydramine-Ibuprofen has serious interactions with at least 486 other drugs.
• Diphenhydramine-Ibuprofen has serious interactions with at least 131 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to NSAIDs or aspirin
• Active GI bleeding disorder
• Breastfeeding
• Unless you have time for a full night's sleep
• In children below 12 years of age
• Right before or after heart surgery
• Concomitant administration with any other product containing diphenhydramine, even one used on the skin
• Experience sleeplessness without pain

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diphenhydramine-Ibuprofen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diphenhydramine-Ibuprofen?”

Cautions

• Asthma (bronchial), cardiac disease, CHF, hepatic/renal impairment, hypertension
• Avoid driving or operating machinery
• When using this product avoid alcoholic beverages, do not drive motor vehicles or operate machinery, and take with food or milk if stomach upset occurs, drowsiness may occur
• Diphenhydramine: Caution in narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction
• If pregnant or breastfeeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery
• Before taking this medication the patient should first ask a doctor if history of stomach bleeding, experienced problems or serious side effects from taking pain relievers or fever reducers, a history of stomach problems, including heartburn, a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or stroke, taking a diuretic, history of breathing problems, including emphysema or chronic bronchitis, diagnosed with glaucoma, difficulty urinating due to enlarged prostate gland
• Ask a physician or pharmacist before taking this medication if taking sedatives or tranquilizers, or any other sleep aid, under a doctor's care for any continuing medical illness, taking any other antihistamines, or taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin, taking any other drug
• The patient should discontinue use if experiencing pain that gets worse or lasts more than 10 days, sleeplessness persists continuously for more than 2 weeks; insomnia may be a symptom of a serious underlying medical illness; if redness or swelling is present in the painful area, any new symptoms appear
• Cardiovascular risk
  • NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke; these can be fatal; the risk is higher if you use more than directed or for longer than directed
  • The risk may increase with the duration of use
  • Patients with risk factors for or existing cardiovascular disease may be at greater risk
  • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)
• Gastrointestinal risk
  • NSAIDs increase the risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
  • The risk of severe stomach bleeding is higher if you have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, are age 60 or older, take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others], take more or for a longer time than directed, have 3 or more alcoholic drinks every day while using this product
  • GI adverse events may occur at any time during use & without warning symptoms
  • Elderly patients are at greater risk for serious GI events
  • The patient should discontinue use if experiencing signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, experiencing stomach pain that does not get better, or when experiencing symptoms of heart problems or stroke, including chest pain, trouble breathing, leg swelling, slurred speech, weakness in one part or side of the body

Pregnancy and Lactation

• Ask a healthcare professional before use; important not to use ibuprofen during the last 3 months of pregnancy unless directed to do so by a physician because it may cause problems in the unborn child or complications during delivery
• The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to no aspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)
• Lactation
  • Diphenhydramine: Enters breast milk; may decrease breast milk production; contraindicated with breastfeeding
  • Ibuprofen: No lactation studies have been conducted with ibuprofen; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on effects of ibuprofen on milk production or a breastfed infant; not recommended (AAP Committee states "compatible with nursing")