FACT: FACT:

Advil® demonstrates a high overdose safety margin compared with Tylenol®1

Overdose Safety Overdose Safety

COMPARISON OF ADVERSE EVENTS (AEs) IN OVERDOSE BETWEEN ADVIL AND TYLENOL®

AEs observed with ibuprofen overdose include GI disturbance, CNS depression, and acute renal failure. Symptoms appear within 4 hours, are largely reversible with supportive therapy, and display a low risk of long-term effects.

AEs observed with acetaminophen overdose include hepatotoxicity and require at least 24 hours to develop.1 Acetaminophen overdose can lead to liver failure and death1,3,4:

  • There are 78,000 emergency department visits annually for non-abuse–related acetaminophen overdose
  • There were 1500 deaths from accidental acetaminophen overdose reported between 2001 and 2010 in the United States

PREVALENCE OF LIFE-THREATENING AEs

In a study that compared the effects of aspirin, acetaminophen, and ibuprofen in overdose, there were prolonged, severe, or life-threatening symptoms reported in 5.4%, 5.2%, and 1.6% of adult patients, respectively.

PERCENTAGE OF PATIENTS EXPERIENCING PROLONGED, SEVERE, OR LIFE-THREATENING SYMPTOMS IN OVERDOSE4

Ibuprofen: 1.6% (n=1557); Acetaminophen 5.2% (n=4888); aspirin 5.4% (n=3709)

 

A large-scale review article concluded that, when compared with all analgesics, OTC ibuprofen is less toxic in serious overdose situations and is rarely associated with death from either accidental or intentional overdose (or with serious adverse events).

Additionally, ibuprofen has no potential drug dependency or narcotic side effects.1

SAFETY MARGINS OF OTC ANALGESICS1

Drug

Maximum single dose/daily dose

Observed toxic dose

Clinical effects

(toxic)

Safety margin (maximum single dose/daily dose)

Acetaminophen

1 g/4 g

10 g

Hepatotoxicity, may progress to hepatic failure. Acute renal failure, coma, metabolic acidosis, myocardial injury

10/2.5

Aspirin

1 g/4 g

9 g*

Range from respiratory alkalosis, metabolic acidosis, lethargy, dehydration, nausea, vomiting to coma, seizures, encephalopathy, pulmonary edema, coagulopathy, cerebral edema

9/2.25

 

Ibuprofen

400 mg/
1200 mg

48 g

Range from abdominal pain, nausea, vomiting, drowsiness, headache, tinnitus and ataxia to apnea, acute lung injury, metabolic acidosis, coma, seizures, acute renal failure, rhabdomyolysis, hepatotoxicity, thrombocytopenia, hypotension and hypothermia

120/40

Naproxen Sodium

440 mg/
660 mg

25 g

Range from CNS depression, sedation, dystonia, prolonged PT to apnea, seizures, metabolic acidosis

63/21

Ketoprofen

25 mg/75 mg

2.4 g

Range from somnolence, seizures, tachycardia to dyspnea, bronchospasm, liver and/or renal toxicity

96/32

*Calculated based on 60 kg individual.
The higher the number, the wider the drug’s margin of safety.