Drug profile
Bisoprolol
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- The usual starting dose is 5 mg once daily.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
- In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic
Disease in WARNINGS ).
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
- If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to
10 mg and then, if necessary, to 20 mg once daily.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Safety and effectiveness in pediatric patients have not been established.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'pediatric
use', retrieved 2026-08-29
- The dose of bisoprolol fumarate tablets must be individualized to the needs of the
patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may
be an appropriate starting dose (see Bronchospastic Disease in WARNINGS ). If the
antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg
and then, if necessary, to 20 mg once daily.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- Patients with Renal or Hepatic Impairment In patients with hepatic impairment
(hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40
mL/min), the initial daily dose should be 2.5 mg and caution should be used in
dose-titration.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
- Since limited data suggest that bisoprolol fumarate is not dialyzable, drug
replacement is not necessary in patients undergoing dialysis.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Patients with Renal or Hepatic Impairment In patients with hepatic impairment
(hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40
mL/min), the initial daily dose should be 2.5 mg and caution should be used in
dose-titration.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'dosage and
administration', retrieved 2026-08-29
PREGNANCY
- In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day
which is 375 and 77 times the MRHD on the basis of body weight and body surface
area, respectively.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy',
retrieved 2026-08-29
- Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and
maternotoxic (decreased food intake and body weight gain) at 150 mg/kg/day.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy',
retrieved 2026-08-29
- The fetotoxicity in rats occurred at 125 times the MRHD on a body weight basis and
26 times the MRHD on the basis of body surface area.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the
milk of lactating rats.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing
mothers', retrieved 2026-08-29
- It is not known whether this drug is excreted in human milk.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing
mothers', retrieved 2026-08-29
- Because many drugs are excreted in human milk caution should be exercised when
bisoprolol fumarate is administered to nursing women.
Source: US FDA label for bisoprolol (Bisoprolol fumarate), section 'nursing
mothers', retrieved 2026-08-29