acetaminophen/pamabrom/pyridoxine (OTC)

Frequency Not Defined

Angioedema

Laryngeal edema

Pruritic maculopapular rash

Urticaria

Agranulocytosis

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Hepatotoxicity

Anaphylactoid reaction

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Repeated administration in patients with anemia, cardia, pulmonary, or renal disease

Cautions

Risk of hepatotoxicity; higher in alcoholics, or with use of more than 1 acetaminophen-containing product

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

G6PD deficiency

Pregnancy category: C

Lactation: excreted in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Acetaminophen: Acts on hypothalamus to produce antipyresis

Pamabrom: Weak diuretic action

Pyridoxine: Vitamin B6 supplement