Drug profile
Amlodipine
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Adult recommended starting dose: 5 mg once daily with maximum dose10 mg once
daily.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of amlodipine
besylate tablets is 5 mg once daily with a maximum dose of 10 mg once daily.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- Effect of amlodipine on blood pressure in patients less than 6 years of age is not
known.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'pediatric
use', retrieved 2026-08-29
- Adult recommended starting dose: 5 mg once daily with maximum dose10 mg once
daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily. ( 2.1 ) Pediatric starting
dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of
5 mg daily have not been studied in pediatric patients.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily.
Source: US FDA label for amlodipine (Amlodipine besylate), 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 amlodipine (Amlodipine
besylate), retrieved 2026-08-29
HEPATIC IMPAIRMENT
- ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
- Small, fragile, or elderly patients, or patients with hepatic insufficiency may be
started on 2.5 mg once daily and this dose may be used when adding amlodipine
besylate tablets to other antihypertensive therapy.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', retrieved 2026-08-29
- The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the
lower dose suggested in the elderly and in patients with hepatic insufficiency.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'dosage and
administration', 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 amlodipine (Amlodipine besylate), section 'pregnancy',
retrieved 2026-08-29
- Amlodipine should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'pregnancy',
retrieved 2026-08-29
- No evidence of teratogenicity or other embryo/fetal toxicity was found when
pregnant rats and rabbits were treated orally with amlodipine maleate at doses up
to 10 mg amlodipine/kg/day (respectively, 8 times 2 and 23 times 2 the maximum
recommended human dose of 10 mg on a mg/m 2 basis) during their respective periods
of major organogenesis.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- It is not known whether amlodipine is excreted in human milk.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'nursing
mothers', retrieved 2026-08-29
- In the absence of this information, it is recommended that nursing be discontinued
while amlodipine is administered.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'nursing
mothers', retrieved 2026-08-29
- ( 8.1 ) Nursing: Discontinue when administering amlodipine besylate tablets.
Source: US FDA label for amlodipine (Amlodipine besylate), section 'use in
specific populations', retrieved 2026-08-29