Advil Tablets
Advil® delivers superior relief vs other analgesics
Experts and patients have trusted Advil for effective pain relief for 35+ years.
Clinical studies show that the medicine in Advil is a superior choice compared to acetaminophen. And when used as directed, Advil also has a proven overall safety profile.
Advil is clinically proven to provide relief for a variety of pain conditions. It is indicated for the temporary relief of minor aches and pains due to:
- Headache
- Toothache
- Backache
- Menstrual cramps
- The common cold
- Muscular aches
- Minor pain of arthritis
- The temporary reduction of fever
Advil is tough on acute pain and easy on your patients
Advil is more effective than Tylenol® for treating tough acute pain. In fact, no other over-the-counter (OTC) pain reliever has been shown to be more effective than ibuprofen.*
Proven superiority, fast onset
Clinical studies of dental pain, pain from the common cold, tension-type headaches, and muscle soreness have demonstrated that ibuprofen (Advil) is more effective than acetaminophen (Tylenol).
An additional study in osteoarthritis (OA) showed that ibuprofen provided a greater decrease in pain intensity than acetaminophen did after the initial dose. The same study also concluded that over the course of 14 days, Advil provided greater sustained pain relief and significantly greater efficacy versus Tylenol.
Advil has a favorable safety profile*
As with any medication, there are risks associated with the use of ibuprofen. However, research has shown that ibuprofen at OTC doses has a proven overall safety profile. A recent review confirmed that at OTC doses, ibuprofen has a low incidence of serious gastrointestinal (GI) events and minimal risk of causing renal and associated cardiovascular events, among others.
Also, when used as directed, ibuprofen 400 mg has a favorable GI safety profile. There is a dose relationship with risk for adverse events with ibuprofen and other NSAIDs, which are generally well tolerated at lower OTC doses.
For patients with any of the risk factors below, doctors should discuss the individual benefits/risks of using NSAIDs.
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Gastrointestinal: Advil was observed to have a low risk of serious GI events in clinical studies
Ibuprofen has a favorable gastrointestinal (GI) safety profile at dosages of 800 mg to 1200 mg per day (in OTC dose).
Clinical studies have shown that when OTC ibuprofen is taken as directed by the label for no longer than 10 days, there is a low increased risk of stomach complaints or bleeding.
- A recent literature review found that in OTC doses of ibuprofen, there was a consistently low risk of serious GI events and that nonserious GI events are probably reversible upon cessation of the drug
- An epidemiologic study by Lewis et al and a systematic review by Henry and McGettigan found no significant increased risk of serious upper GI toxicity at dosages <1200 mg daily
- In a study by Moore et al, more subjects reported significant digestive adverse events for 1 to 7 days with aspirin (7.1%) or acetaminophen (5.3%) than with ibuprofen (4.0%)
- Studies have demonstrated that higher doses of ibuprofen (and other NSAIDs) are associated with a greater risk of GI side effects (odds ratio 4:6) vs lower (OTC) doses (odds ratio 1:1)
Safety information for your patients
As indicated in the Advil Drug Facts, ibuprofen, like all NSAIDs, may cause severe stomach bleeding. Risk of stomach bleeding increases if patients:
- Consume 3 or more alcoholic beverages per day
- Are aged 60 years or older
- Are taking anticoagulants or steroids
- Are taking other drugs containing NSAIDs
- Have a history of stomach bleeding, ulcers, or other bleeding problems
- Take more than directed or for longer than directed (taking ibuprofen at higher doses than the approved OTC dosing and/or for longer than 10 days also increases this risk)
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Cardiovascular: Advil presents minimal cardiovascular risk as observed in clinical studies
Several medical publications have evaluated the cardiovascular safety profile of OTC ibuprofen
A comprehensive review of existing cardiovascular safety data shows that when ibuprofen is used at OTC doses according to label directions, cardiovascular risk is minimal.
Data from a series of publications suggest that OTC ibuprofen is not strongly associated with an increased risk of:
- Cardiovascular events (myocardial infarction [MI], stroke)
- Cardiorenal events (high blood pressure, congestive heart failure)
However, multiple studies have found that taking ibuprofen or other NSAIDs at Rx doses over prolonged periods can increase the risk of developing cardiovascular events.
Advil for patients already taking daily low-dose aspirin
For patients already on, or for whom you are considering initiating, a cardioprotective aspirin regimen:
- Taking ibuprofen at least 8 hours before or a half hour after the dosing of immediate-release low-dose aspirin is a practical method to minimize potential impairment of the antiplatelet effect of aspirin
- Because the effect of aspirin taken daily on platelets is long lasting, the occasional use of ibuprofen poses a minimal risk of attenuating the antiplatelet effect of low-dose aspirin
What is the CV risk associated with low-dose ibuprofen?
A cohort study that examined 4795 cases of acute MI and death due to coronary heart disease showed the odds ratio for MI for ibuprofen at OTC doses was 1:06 (95% CI; 0.87 to 1.29). Prior history of coronary heart disease or concomitant intake of aspirin did not increase the risk of MI from ibuprofen.
A case-controlled analysis performed to assess the risk of NSAIDs in relation to acute MI found that ibuprofen did not pose an increased risk of MI.
Safety information for your patients
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.
According to the Advil Drug Facts, patients should not use ibuprofen right before or after heart surgery. Patients are directed to ask a doctor before use if they have high blood pressure, heart disease, or have had a stroke.
Patients should stop use and ask a doctor if they have symptoms of heart problems or stroke, including:
- Chest pain
- Trouble breathing
- Weakness in one part or side of the body
- Slurred speech
- Leg swelling
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Renal: The medicine in Advil has a low risk factor for developing renal conditions as observed in clinical studies
Clinical evidence suggests over-the-counter (OTC) ibuprofen has a low risk factor for developing acute or chronic renal conditions.
Renal adverse effects at OTC doses
A well-controlled clinical trial (N=25) and an epidemiologic study with a total of 1574 patients receiving ibuprofen indicate that the frequency of kidney function–related adverse events with OTC doses of ibuprofen is low.
A double-blind study evaluating the renovascular effects of OTC ibuprofen in elderly hypertensive patients with mild renal impairment found that ibuprofen did not appear to be a risk factor in the development of additional renal compromise or the diminishing of hypertension control (N=25).
Renal adverse effects at Rx doses
NSAIDs, including ibuprofen, demonstrate an increased risk of causing renal impairment at high (Rx) doses, especially among elderly patients or patients with reduced renal function.
Serious renal pathology has been rarely seen with ibuprofen use. These reactions have not been observed in OTC ibuprofen trials.
Safety information for your patients
The Advil Drug Facts recommend that patients with kidney disease or those who are taking a diuretic should consult a doctor before use.
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Hepatic: Advil demonstrates a low risk of hepatic injury
The use of over-the-counter (OTC) ibuprofen demonstrates a low risk of developing liver injury, especially compared with the severe liver damage observed with acetaminophen overdose and the occasional liver reactions from aspirin.
Advil demonstrates a low risk of acute liver damage
Liver safety data from systematic reviews, population-based studies, and spontaneous reporting databases indicate that there is a low risk of acute liver damage associated with ibuprofen use.
The hepatic safety profile of ibuprofen extends to overdose situations.
When compared with acetaminophen, the incidence of ibuprofen-induced liver injury is very low:
- The hepatotoxicity of acetaminophen is well documented and dose related
- When high toxic doses of acetaminophen were taken, irreversible liver damage was observed
Safety information for your patients
The Advil Drug Facts recommend that patients with liver cirrhosis should consult a doctor before use.
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Advil dosing
Recommend Advil for clinically proven, effective pain relief with a favorable safety profile
Learn more about Advil and pain relief
Overview of pain conditions
Learn about common pain conditions such as OA pain, headache, sprains and strains, and more, and discover how Advil can give your patients relief.
Patient care resources
Access educational resources for your patients, to help them have a better understanding of their pain condition.
