Drug profile
Pentoxifylline
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release
tablet form is one tablet (400 mg) three times a day with meals.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and
administration', retrieved 2026-08-29
- If patients develop these effects it is recommended that the dosage be lowered to
one tablet twice a day (800 mg/day).
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and
administration', retrieved 2026-08-29
- DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release
tablet form is one tablet (400 mg) three times a day with meals. While the effect
of pentoxifylline extended-release tablets may be seen within 2 to 4 weeks, it is
recommended that treatment be continued for at least 8 weeks. Efficacy has been
demonstrated in double-blind clinical studies of 6 months duration. Digestive and
central nervous system side effects are dose related.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness in pediatric patients have not been established.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'pediatric use',
retrieved 2026-08-29
RENAL IMPAIRMENT
- In patients with severe renal impairment (creatinine clearance below 30 mL/min)
reduce dose to 400 mg once a day.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and
administration', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Dosing information cannot be provided for patients with hepatic impairment.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'dosage and
administration', retrieved 2026-08-29
PREGNANCY
- Category C: Teratogenicity studies have been performed in rats and rabbits using
oral doses up to 576 mg/kg and 264 mg/kg, respectively.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy',
retrieved 2026-08-29
- On a weight basis, these doses are 24 and 11 times the maximum recommended human
daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the
MRHD.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy',
retrieved 2026-08-29
- No evidence of fetal malformation was observed.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- Pentoxifylline and its metabolites are excreted in human milk.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'nursing
mothers', retrieved 2026-08-29
- Because of the potential for tumorigenicity shown for pentoxifylline in rats, a
decision should be made whether to discontinue nursing or discontinue the drug,
taking into account the importance of the drug to the mother.
Source: US FDA label for pentoxifylline (Pentoxifylline), section 'nursing
mothers', retrieved 2026-08-29