Cyproheptadine

FDA label, TRUPHARMA, LLC, oral, effective 2026-08-20. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

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Label text (1 paragraph)

Drug interactions MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Contraindications

Newborn or Premature Infants This drug should not be used in newborn or premature infants. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Other Conditions Hypersensitivity to cyproheptadine and other drugs of similar chemical structure. Monoamine oxidase inhibitor therapy ( See DRUG INTERACTIONS . ) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

C

Likelihood score C: Probable rare cause of clinically apparent liver injury.

Cyproheptadine is a first generation antihistamine used in the treatment of allergic rhinitis and urticaria and as an appetite stimulant. Cyproheptadine has been linked to rare instances of clinically apparent liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Cyproheptadine (NIDDK, public domain)Chapter updated Jan 16, 2017

Pregnancy and lactation

Pregnancy

Pregnancy Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. Two studies in pregnant women, however, have not shown that cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy. No teratogenic effects were observed in any of the newborns.

Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed.

Lactation

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from cyproheptadine, 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 ( see CONTRAINDICATIONS ).

Breastfeeding (LactMed)

Unless it is intentionally being used to lower maternal serum prolactin levels, cyproheptadine should be avoided during lactation because it may interfere with lactation, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. The nonsedating antihistamines are preferred alternatives.

Alternatives LactMed suggests considering:
Source: LactMed: Cyproheptadine (NICHD, public domain)Revised Feb 15, 2026

Supply and cost

Drug shortage status

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Therapeutic equivalence (Orange Book)

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