Advil safety and tolerability
Advil: a proven safety profile for a wide range of patients*
OTC doses of Advil have a low risk of cardiovascular, renal, or hepatic adverse events.1,2 †
*When used as directed.†Studies evaluating the product’s efficacy and tolerability/safety.
Not all NSAIDs are the same: Advil has a balanced selectivity profile targeting COX 1 and COX 2 enzymes3
Greater balance of selectivity reduces risk
The medicine in Advil is one of the most centrally balanced between COX 1 and COX 2 selectivity among NSAIDs,3 supporting its good tolerability by patients.
Pharmacokinetic data
Advil: Rapidly metabolized to minimize systemic exposure2
The medicine in Advil is highly protein bound and rapidly metabolized, minimizing systemic exposure:
- Rapidly absorbed and distributed throughout the body
- Rapid onset of efficacy—less than 30 minutes
- Results in lower blood concentration levels while delivering relief
Advil has 35+ years of clinical studies & real-world evidence confirming its safety profile
COX inhibitors, like NSAIDs, are widely used due to their anti-inflammatory and antipyretic properties and are indicated for mild pain by the WHO.7
Favorable overall safety profile
Results of a meta-analysis of 15 double-blind, randomized, placebo-controlled clinical studies:
No significant differences in AEs among or between ibuprofen, acetaminophen, or placebo-treated patients1,4*
- Clinical studies show no significant differences were observed in overall frequency of AEs between the medicine in Advil and Tylenol, both of which had rates similar to placebo
- AEs with OTC doses of Advil were generally present at similar rates as placebo†
Additionally, unlike prescription doses of ibuprofen, OTC doses of Advil, when taken as directed, have a low risk for occurrence of AEs across all body systems2
*When used as directed.†AE rates increased with higher dosing similar to Rx.
Recommend Advil—proven effective pain relief with a favorable safety profile.
Advil has 35+ years of clinical studies & real-world evidence confirming its safety profile.
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Cardiovascular safety profile
![Image to show the cardiovascular system]()
Recent data relating to hypertension
The PATH-BP trial was a double-blind, placebo-controlled crossover study regarding the effect of acetaminophen use on blood pressure in patients with hypertension5
According to the authors, acetaminophen, at OTC dosing levels, statistically significantly increased systolic blood pressure by 4.7 mmHg versus placebo over a 2-week period5
Advil, with a proven safety profile over a 35-year brand history, has a similar cardiovascular safety profile to other products in the NSAID class.*
Low probability of cardiovascular events
- OTC ibuprofen poses no greater risk of acute myocardial infarction compared to other NSAIDs, acetaminophen, or placebo†2,6
- In a case-control study, OTC ibuprofen had similar cardiovascular risks to OTC naproxen2
- OTC Ibuprofen poses no greater risk of stroke compared to other NSAIDs‡2
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
*When used as directed.†Relative to non-use.‡Naproxen and celecoxib.
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Renal safety profile
![Image to show the renal system]()
Low probability of renal events with OTC use of ibuprofen2*
- When taking Advil as directed, clinical studies showed that the risk of kidney-related side effects was low2,4
- Clinical data show that taking Advil as directed at OTC dosing for less than 10 days is associated with a low risk of kidney-related side effects4
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.
*When used as directed.
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Hepatic safety profile
![Image to show the hepatic system]()
Low risk of hepatotoxicity with Advil*
- Clinical data support that there is a low risk of hepatotoxicity with OTC ibuprofen use2
- Ibuprofen is less likely than acetaminophen to produce hepatic injury in patients2
Safety information for your patients
The Advil Drug Facts recommend that patients with liver cirrhosis should consult a doctor before use.
*When used as directed.
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Gastrointestinal safety profile
![Image to show the gastrointestinal system]()
Ibuprofen has generally good gastrointestinal (GI) tolerability based on study data when used at dosages of 800 mg to 1200 mg per day (OTC dose)4*
- 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 bleeding4
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)
*When used as directed.
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Advil Tablets
Experts and patients have trusted Advil for safe and effective pain relief for 35+ years.
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An important clinical study
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