Quick answers
- What is Cyproheptadine used for?
- The FDA-approved label (Cyproheptadine Hydrochloride, Trupharma, LLC, August 20, 2026) says: “Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Cyproheptadine?
- The “Adverse Reactions” section of the FDA label (Cyproheptadine Hydrochloride, Trupharma, LLC, August 20, 2026) begins: “Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Cyproheptadine?
- The “Drug Interactions” section of the FDA label (Cyproheptadine Hydrochloride, Trupharma, LLC, August 20, 2026) begins: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cyproheptadine have a boxed warning?
- No. None of the 34 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cyproheptadine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cyproheptadine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 13, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cyproheptadine?
- 23 companies list prescription products of Cyproheptadine in the FDA NDC Directory, including Bryant Ranch Prepack, Quagen Pharmaceuticals LLC and TruPharma, LLC.
What Cyproheptadine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. …
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Cyproheptadine Hydrochloride, Trupharma, LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 34 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 34 FDA labels for this medicine have a boxed warning.
Cyproheptadine side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.
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Special Senses Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Genitourinary Urinary frequency, difficult urination, urinary retention, early menses. Respiratory Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous Fatigue, chills, headache, increased appetite/weight gain. Central Nervous System Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Genitourinary Urinary frequency, difficult urination, urinary retention, early menses. Respiratory Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous Fatigue, chills, headache, increased appetite/weight gain.
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Cyproheptadine drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
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.
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Cyproheptadine dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Each tablet contains 4 mg of cyproheptadine hydrochloride. Pediatric Patients Age 2 to 6 years The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m2).
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The usual dose is 2 mg (1/2 tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day. Age 7 to 14 years The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day. Adults The total daily dose for adults should not exceed 0.5 mg/kg/day. The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Cyproheptadine in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a 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.
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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.
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Cyproheptadine and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
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).
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
When Cyproheptadine should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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.
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Monoamine oxidase inhibitor therapy (See DRUG INTERACTIONS.) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Cyproheptadine overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in pediatric patients. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.) as well as gastrointestinal symptoms may occur. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac. If patient is unable to vomit, perform gastric lavage followed by activated charcoal.
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Isotonic or 1/2 isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children. When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered. Dosage and frequency of administration are dependent on age, clinical response, and recurrence after response. (See package circulars for physostigmine products.) Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and, therefore, are valuable for their action in rapid dilution of bowel content. Stimulants should not be used. Vasopressors may be used to treat hypotension. The oral LD 50 of cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively.
— FDA label: Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Solution · Syrup |
|---|---|
| Route | Oral |
| Prescription products | 38 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cyproheptadine 2 mg/5 mL solution | Generic | $0.0422 per mL |
| cyproheptadine hydrochloride 2 mg/5 mL solution | Generic | $0.0422 per mL |
| cyproheptadine hydrochloride 2 mg/5 mL syrup | Generic | $0.0422 per mL |
| cyproheptadine hydrochloride 4 mg tablet | Generic | $0.0685 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack7 products
- Quagen Pharmaceuticals LLC4 products
- TruPharma, LLC2 products
- Remedyrepack Inc.2 products
- QPharma, Inc.2 products
- A-S Medication Solutions2 products
- Rising Pharma Holdings, Inc.2 products
- Chartwell RX, LLC2 products
- PD-Rx Pharmaceuticals, Inc.1 product
- Tris Pharma Inc1 product
- Strides Pharma Science Limited1 product
- Ingenus Pharmaceuticals, LLC1 product
- Atlantic Biologicals Corp.1 product
- Golden State Medical Supply, Inc.1 product
- Unichem Pharmaceuticals (USA), Inc.1 product
- AvPAK1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Zydus Lifesciences Limited1 product
- Atlantic Biological Corp.1 product
- Pangea Pharmaceuticals, LLC1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Patrin Pharma, Inc.1 product
- Method Pharmaceuticals, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (14)
- ANDA088212Chartwell Rx · May 26, 1983
- ANDA040537Mountain · September 30, 2003
- ANDA040668Rising · June 28, 2006
- ANDA205087Ingenus Pharms LLC · September 23, 2015
- ANDA206553Tp Anda Holdings · November 29, 2016
- ANDA207555Rising · January 31, 2017
- ANDA208938Zydus Pharms · May 19, 2017
- ANDA203191Chartwell Molecular · July 13, 2017
- ANDA209172Strides Pharma Intl · April 11, 2018
- ANDA209108Pharmazone · October 16, 2018
- ANDA206676Regcon Holdings · April 12, 2019
- ANDA212423Quagen · May 22, 2019
- ANDA212491Quagen · February 24, 2021
- ANDA205431Tris Pharma Inc · December 21, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 13, 2026 · Class II · Ongoing · D-0724-2026
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504- — Rising Pharma Holding, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 866021, 866144 |
|---|---|
| SPL set ID of the quoted label | 9c0b47c0-ecd2-450f-9dcb-c262db92866e |
| FDA labels (SPL) | 34 |
| FDA applications | 14 ANDA |
| Active ingredients (FDA) | CYPROHEPTADINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Bryant Ranch PrepackMaker or distributor
- Quagen Pharmaceuticals LLCMaker or distributor
- TruPharma, LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cyproheptadine Hydrochloride, Trupharma, LLC, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →