{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "omega-3",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/omega-3.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    },
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'caution should be exercised when omega-3-acid ethyl esters capsules are administered to a nursing'."
    }
  }
}