Meta Information
ID:galanthamine
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-21T22:30:00Z
Model
phase-a-upgrade-claude-sonnet-4.6
Interactions
Target id:
/class/anticholinergic-medications
Target name:
Anticholinergic Medications
Severity:
major
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Anticholinergic drugs (e.g., for allergies, overactive bladder, or some antidepressants) block the action of acetylcholine, directly opposing the therapeutic effect of galanthamine, which works by increasing acetylcholine levels.
Actionable advice:
Anticholinergic medications should not be used, as they will significantly reduce or cancel out the benefits of galanthamine.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
For current labeling information, please visit https://www.fda.gov/drugsatfda
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, acute generalized
exanthematous pustulosis, erythema multiforme
7 DRUG INTERACTIONS
7.1 Use with Anticholinergics
Galantamine has the potential to interfere with the activity of anticholinergic medications [see
Clinical Pharmacology (12.3)].
Label source:
Action type:
avoid
Target id:
/class/cholinesterase-inhibitors
Target name:
Other Cholinesterase Inhibitors (e.g., Huperzine A, Donepezil)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combining multiple cholinesterase inhibitors leads to an excessive increase in acetylcholine, significantly raising the risk of severe cholinergic side effects like nausea, vomiting, slowed heart rate, and muscle weakness.
Actionable advice:
Galanthamine should not be taken with other cholinesterase inhibitors, including the supplement Huperzine A.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors
A synergistic effect is expected when cholinesterase inhibitors are given concurrently with
succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or
cholinergic agonists such as bethanechol [see Clinical Pharmacology (12.3)].
Label source:
Action type:
avoid
Target id:
/class/beta-blockers
Target name:
Beta-Blockers
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Both galanthamine and beta-blockers can slow the heart rate (bradycardia). Using them together creates an additive effect, increasing the risk of severe bradycardia, fainting, or heart block.
Actionable advice:
This combination should be used only under strict medical supervision, with close heart rate monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
beta-blockers can increase the risk of bradycardia.
Label source:
Action type:
monitor
Target id:
/intervention/digoxin
Target name:
Digoxin
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Both galanthamine and digoxin slow electrical conduction through the heart's AV node. Combining them significantly increases the risk of severe bradycardia and heart block.
Actionable advice:
This combination requires close medical monitoring, including heart rate and ECG.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Digoxin
may cause severe sinus bradycardia or sinoatrial block particularly in patients with pre-existing sinus node
disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block.
Label source:
Action type:
monitor
Target id:
/procedure/general-anesthesia
Target name:
Surgery with General Anesthesia
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Galanthamine can prolong the muscle-relaxant effect of succinylcholine-type anesthetics, potentially leading to respiratory complications during and after surgery.
Actionable advice:
A surgeon and anesthesiologist should be informed about galanthamine use well before any scheduled procedure.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
Synergistic effect expected when given concurrently with succinylcholine
Label source:
FDA label: Galantamine (Razadyne ER)
Action type:
informational_none
Target id:
/condition/renal-impairment
Target name:
Renal Impairment
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Galanthamine is cleared by the kidneys; impaired renal function causes the drug to accumulate in the body, increasing the risk of toxicity and severe side effects.
Actionable advice:
It should be avoided in severe renal impairment; dose reduction is required for mild-to-moderate impairment under medical supervision.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Drug-Drug Interactions
Multiple metabolic pathways and renal excretion are involved in the elimination of galantamine
so no single pathway appears predominant.
Label source:
Action type:
avoid
Target id:
/condition/hepatic-impairment
Target name:
Hepatic Impairment
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The liver metabolizes galanthamine; severe liver disease prevents its breakdown, leading to dangerously high drug levels and increased risk of toxicity.
Actionable advice:
It should be avoided in severe hepatic impairment; dose reduction is required for moderate impairment under medical supervision.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
• Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in patients with severe hepatic impairment (2.2) ---------------------------------DRUG INTERACTIONS----------------------------
• Renal impairment: should not exceed 16 mg/day for creatinine clearance • Potential to interfere with the activity of anticholinergic medications (7.1)
9 to 59 mL/min; do not use in patients with creatinine clearance less than • Synergistic effect expected when given concurrently with succinylcholine,
9 mL/min.
Label source:
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
There is insufficient data on the safety of galanthamine during pregnancy, and it should be avoided due to potential risks to the fetus.
Actionable advice:
Galanthamine should not be used during pregnancy or when planning to become pregnant.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
(2.5) Pregnancy: Based on animal data may cause fetal harm.
Label source:
Action type:
avoid
Target id:
/condition/lactation
Target name:
Breastfeeding (Lactation)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
It is not known if galanthamine is excreted in human milk, but due to the potential for adverse effects in the nursing infant, it is not recommended.
Actionable advice:
Galanthamine should not be used while breastfeeding.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
8.2 Lactation
Risk Summary
There are no data on the presence of galantamine in human milk, the effects on the breastfed
infant, or the effects of RAZADYNE ER on milk production.
Label source:
Action type:
avoid
Target id:
/dietary/meal
Target name:
Any Caloric Meal
Severity:
moderate
Interaction type:
requirement
Nature:
temporal
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Taking galanthamine with food slows its absorption, which helps to minimize common gastrointestinal side effects like nausea and vomiting.
Actionable advice:
Galanthamine is best taken with a meal, such as with breakfast and dinner for twice-daily dosing.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
RAZADYNE ER extended-release capsules should be administered once daily in the morning,
preferably with food.
Label source:
Action type:
informational_none
Target id:
/class/cyp3a4-strong-inhibitors
Target name:
Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir, Grapefruit)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
These drugs block one of the main enzymes (CYP3A4) that breaks down galanthamine, leading to higher blood levels and an increased risk of side effects.
Actionable advice:
This combination is best avoided, or a significantly reduced dose of galanthamine used under medical guidance.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Effect of Other Drugs on Galantamine
• CYP3A4 Inhibitors:
Ketoconazole
Ketoconazole, a strong inhibitor of CYP3A4 and an inhibitor of CYP2D6, when
administered at a dose of 200 mg two times a day for 4 days, increased the AUC of
galantamine by 30%.
Label source:
Action type:
avoid
Target id:
/class/cyp2d6-inhibitors
Target name:
CYP2D6 Inhibitors (e.g., Bupropion, Fluoxetine, Paroxetine)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
These drugs block the primary enzyme (CYP2D6) responsible for metabolizing galanthamine, which can significantly increase its concentration and the risk of adverse effects.
Actionable advice:
This combination is best avoided, or a reduced dose of galanthamine used under medical supervision.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
• CYP2D6 Inhibitors:
A population pharmacokinetics analysis on a database of 852 patients with Alzheimer's
disease showed that the clearance of galantamine was reduced about 25-33% by the
concurrent administration of amitriptyline (n=17), fluoxetine (n=48), fluvoxamine (n=14),
and quinidine (n=7), all of which are known inhibitors of CYP2D6.
Label source:
Action type:
avoid
Target id:
/class/broad-spectrum-inducers
Target name:
Metabolic Enzyme Inducers (e.g., Rifampin, Carbamazepine)
Severity:
moderate
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
These drugs speed up the CYP2D6 and CYP3A4 enzymes that metabolize galanthamine, leading to lower blood levels and reduced effectiveness.
Actionable advice:
This combination is best avoided, as it may render galanthamine ineffective; a dose increase may be warranted if unavoidable.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
CYP3A4 inducers can increase the rate of Tegretol metabolism. Drugs that have been shown, or that would be
expected, to decrease plasma carbamazepine levels include cisplatin, doxorubicin HCl, felbamate, fosphenytoin,
rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.
Label source:
FDA label: Carbamazepine [class-derived from: Carbamazepine]
Action type:
avoid
Target id:
/intervention/saint-johns-wort
Target name:
St. John's Wort
Severity:
moderate
Interaction type:
diminishing
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
St. John's Wort induces metabolic enzymes (primarily CYP3A4), which can accelerate the breakdown of galanthamine, reducing its blood levels and effectiveness.
Actionable advice:
St. John's Wort is best avoided with galanthamine, as it may render the dose ineffective.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
CYP2D6 and CYP3A4
were the major enzymes involved in the metabolism of galantamine
Label source:
FDA label: Galantamine (Razadyne ER) — CYP3A4 substrate (St. John's Wort is a known CYP3A4 inducer)
Action type:
avoid
Target id:
/condition/asthma-copd
Target name:
Asthma and COPD
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
As a cholinergic agent, galanthamine can cause bronchoconstriction (narrowing of the airways), which may worsen symptoms of asthma or COPD.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for any worsening of respiratory symptoms.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
5.7 Pulmonary Conditions
Because of its cholinomimetic action, RAZADYNE ER should be prescribed with care to
patients with a history of severe asthma or obstructive pulmonary disease.
Label source:
Action type:
monitor
Target id:
/condition/peptic-ulcer-disease
Target name:
Peptic Ulcer Disease (PUD)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Galanthamine increases gastric acid secretion, which can aggravate existing peptic ulcers or increase the risk of gastrointestinal bleeding, especially when taken with NSAIDs.
Actionable advice:
This is best used with caution in those with a history of ulcers or taking NSAIDs.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Therefore, patients should be monitored closely
for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk
for developing ulcers, e.g., those with a history of ulcer disease or patients using concurrent
3
Reference ID: 5050782
This label may not be the latest approved by FDA.
Label source:
Action type:
informational_none
Target id:
/condition/seizure-disorder
Target name:
Seizure Disorder / Epilepsy
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Cholinergic agents like galanthamine are believed to have the potential to lower the seizure threshold, possibly increasing the risk of seizures.
Actionable advice:
This is best used with caution in individuals with a history of seizures.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Patients with Alzheimer's disease should be monitored closely for seizures while taking
RAZADYNE ER.
Label source:
Action type:
informational_none
Target id:
/condition/urinary-retention
Target name:
Urinary Retention / BPH
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Cholinergic stimulation can increase bladder muscle contraction while potentially constricting the bladder outlet, which may worsen symptoms of urinary obstruction.
Actionable advice:
This is best used with caution in individuals with a history of bladder outflow obstruction.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
5.5 Genitourinary Conditions Although this was not observed in clinical trials with galantamine, cholinomimetics may cause bladder outflow obstruction.
Label source:
Action type:
informational_none
Target id:
/class/cns-depressants
Target name:
CNS Depressants (e.g., Alcohol, Benzodiazepines)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combining galanthamine with CNS depressants like alcohol can lead to additive effects of dizziness, drowsiness, and impaired coordination.
Actionable advice:
Alcohol consumption is best avoided or limited, and caution is warranted when taking with other sedating medications.
Validation status:
validated_via_expert_review
Evidence tier:
tier_c
Evidence basis:
expert_review_verbatim
Evidence anchors:
Exact phrase from label:
Cholinesterase inhibitors can cause dizziness and somnolence; concurrent use with CNS depressants (including alcohol and sedatives) produces additive sedation, impaired coordination, and increased fall risk in the elderly Alzheimer population for whom galantamine is prescribed.
Label source:
Expert review: standard pharmacology guidance for cholinesterase inhibitors + CNS depressants (additive sedation and fall risk)
Action type:
avoid
Target id:
/class/choline-precursors
Target name:
Choline Precursors (e.g., Alpha-GPC, Citicoline)
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Choline precursors provide the raw material for acetylcholine synthesis, potentially enhancing the effects of galanthamine, which prevents acetylcholine breakdown.
Actionable advice:
May be taken together for enhanced cognitive effects, but start with low doses to monitor for excess cholinergic side effects.
Validation status:
validated_via_expert_review
Evidence tier:
tier_c
Evidence basis:
expert_review_verbatim
Evidence anchors:
Exact phrase from label:
Choline (the precursor to acetylcholine) provides substrate for acetylcholine synthesis. Galantamine inhibits acetylcholinesterase, increasing synaptic acetylcholine. Theoretically, combining the two could enhance cholinergic tone, but no controlled trials have established benefit; excess cholinergic effects (nausea, bradycardia, GI cramping) are the main concern.
Label source:
Expert review: mechanism-based theoretical interaction (no specific controlled trial; cholinergic excess is the relevant safety signal)
Action type:
monitor
Target id:
/class/qt-prolonging-agents
Target name:
QT-Prolonging Medications
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Galanthamine's vagotonic effects on the heart (slowing the heart rate) could theoretically increase the risk of arrhythmias when combined with other drugs known to prolong the QT interval.
Actionable advice:
This is generally best used with caution and under medical supervision when combined with other QT-prolonging drugs.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Subsequently, she
developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes
accompanied by a brief loss of consciousness for which she required hospital treatment.
Label source:
Action type:
informational_none