Advil PM Side Effects
Generic name: diphenhydramine / ibuprofen
Medically reviewed by Drugs.com. Last updated on Aug 23, 2023.
Note: This document contains side effect information about diphenhydramine / ibuprofen. Some dosage forms listed on this page may not apply to the brand name Advil PM.
Applies to diphenhydramine / ibuprofen: oral tablet.
Serious side effects of Advil PM
Along with its needed effects, diphenhydramine/ibuprofen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking diphenhydramine / ibuprofen:
Incidence not known
- Bloody or black, tarry stools
- chest pain, discomfort, or tightness
- decreased urine output
- difficulty in speaking
- dilated neck veins
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular breathing
- irregular heartbeat
- pain or discomfort in the arms, jaw, back, or neck
- severe stomach pain
- slow speech
- stomach cramping or burning
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- vomiting of blood or material that looks like coffee grounds
- weight gain
For Healthcare Professionals
Applies to diphenhydramine / ibuprofen: oral capsule, oral tablet.
The more commonly reported adverse effects include drowsiness and dyspepsia.[Ref]
Frequency not reported: Hypotension, tachycardia, palpitations
Common (1% to 10%): Peripheral edema
Uncommon (Less than 1%): Elevated blood pressure[Ref]
The 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.[Ref]
Very common (Greater than 10%): Drowsiness, sedation
Frequency not reported: Impaired motor skills, dystonic reactions, delirium
Rare (less than 0.1%): Aseptic meningitis, paresthesias, and pseudotumor cerebri
Frequency not reported: Headache, drowsiness, dizziness[Ref]
Frequency not reported: Nausea, dry mouth
Frequency not reported: Dyspepsia, nausea, diarrhea, abdominal pain, flatulence[Ref]
More 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.[Ref]
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[Ref]
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.[Ref]
Frequency not reported: Rash, pruritus, eczema, photosensitivity reactions
Frequency not reported: Erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, anaphylactoid reactions[Ref]
Most 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.[Ref]
Frequency not reported: Urinary retention, dysuria[Ref]
Reductions 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.[Ref]
Frequency not reported: Blurred vision, diplopia, dry eyes
Rare (less than 1%): Blurred vision
Frequency not reported: Scotomata, diplopia[Ref]
Very common (over 10%): Elevations in liver function tests (15%)
Frequency not reported: Jaundice, hepatitis[Ref]
Elevations 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.[Ref]
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.[Ref]
Frequency not reported: Noncardiogenic pulmonary edema[Ref]
Frequency not reported: Depression[Ref]
Common (1% to 10%): Tinnitus
Frequency not reported: Vertigo
More about Advil PM (diphenhydramine / ibuprofen)
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- Drug class: analgesic combinations
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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.