Drug profile
Gemfibrozil
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- The recommended dose for adults is 1200 mg administered in two divided doses 30
minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and
administration', retrieved 2026-08-29
- The recommended dose for adults is 1200 mg administered in two divided doses 30
minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
OVERDOSAGE There have been reported cases of overdosage with gemfibrozil. In one
case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- 10. Pediatric Use Safety and efficacy in pediatric patients have not been
established.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'pediatric use',
retrieved 2026-08-29
- The recommended dose for adults is 1200 mg administered in two divided doses 30
minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY ).
OVERDOSAGE There have been reported cases of overdosage with gemfibrozil. In one
case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'dosage and
administration', 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 gemfibrozil (Gemfibrozil),
retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for gemfibrozil (Gemfibrozil),
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 Gemfibrozil has been shown to produce adverse effects in rats and
rabbits at doses between 0.5 and 3 times the human dose (based on surface area).
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved
2026-08-29
- There are no adequate and well-controlled studies in pregnant women.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved
2026-08-29
- Gemfibrozil should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- Nursing Mothers It is not known whether this drug is excreted in human milk.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human milk and because of the potential for
tumorigenicity shown for gemfibrozil in animal studies, a decision should be made
whether to discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother. 7.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers',
retrieved 2026-08-29
- Hematologic Changes Mild hemoglobin, hematocrit, and white blood cell decreases
have been observed in occasional patients following initiation of gemfibrozil
therapy.
Source: US FDA label for gemfibrozil (Gemfibrozil), section 'nursing mothers',
retrieved 2026-08-29