Omega-3

DRUG INFORMATION

  ADULT
    - Assess triglyceride levels carefully before initiating therapy. Identify other
      causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride
      levels and manage as appropriate. [see Indications and Usage ( 1 )]. Patients
      should be placed on an appropriate lipid-lowering diet before receiving
      omega-3-acid ethyl esters capsules, and should continue this diet during treatment
      with omega-3-acid ethyl esters capsules.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for omega-3 (Omega-3-acid ethyl
      esters), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In patients with hepatic impairment, monitor ALT and AST levels periodically
      during therapy.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'warnings
      and cautions', retrieved 2026-08-29
    - ( 5.3 ) 5.1 Monitoring: Laboratory Tests In patients with hepatic impairment,
      alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should
      be monitored periodically during therapy with omega-3-acid ethyl esters capsules.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'warnings
      and cautions', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Pregnancy Category C: There are no adequate and well-controlled studies in
      pregnant women.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'pregnancy',
      retrieved 2026-08-29
    - It is unknown whether omega-3-acid ethyl esters capsules can cause fetal harm when
      administered to a pregnant woman or can affect reproductive capacity.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'pregnancy',
      retrieved 2026-08-29
    - Omega-3-acid ethyl esters capsules should be used during pregnancy only if the
      potential benefit to the patient justifies the potential risk to the fetus.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'nursing
      mothers', retrieved 2026-08-29
    - The effect of this excretion on the infant of a nursing mother is unknown; caution
      should be exercised when omega-3-acid ethyl esters capsules are administered to a
      nursing mother.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'nursing
      mothers', retrieved 2026-08-29
    - An animal study in lactating rats given oral gavage 14 C-ethyl EPA demonstrated
      that drug levels were 6 to 14 times higher in milk than in plasma.
      Source: US FDA label for omega-3 (Omega-3-acid ethyl esters), section 'nursing
      mothers', retrieved 2026-08-29