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Molecule

Histamine

Also known as histamine phosphate
Available on requestBiologicCold chainImmune stimulants
Presentations
3
Brands
2
Manufacturers
2
Available from stock
0

Histamine is a prescription medicine indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts. MedsAcross supplies Histamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
L03AX14 Histamine · Cytovir-3
US FDA first approval
25 April 1939
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Percutaneous, Intradermal
Dosage forms
Injection, Topical solution
Biologic
Yes
Identifiers
UNII 820484N8I3RxCUI 5333CAS 51-45-6DrugBank DB05381Q61233

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

Source: US FDA prescribing information

Dosing overview

. General Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prior to testing, clean the skin area with ether or alcohol and allow to dry. The back or the volar surface of the arms are the most satisfactory sites for testing. Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret there. The most satisfactory areas of the back are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

Source: US FDA prescribing information

Contraindications

Positive Skin Test Control - Histamine is contraindicated in patients with a history of hypersensitivity to histamine products, and in patients with hypotension, severe hypertension, vasomotor instability, severe cardiac, pulmonary or renal disease.

Source: US FDA prescribing information

Warnings and precautions

POSITIVE SKIN TEST CONTROL - HISTAMINE For Percutaneous (Scratch, Prick or Puncture) Administration Histamine Base: 6mg/mL (Histamine Dihydrochloride: 10mg/mL) This product is to be used by a physician or under the supervision of a physician. Attacks of severe asthma or other serious allergic conditions may be precipitated by the administration of Histamine Dihydrochloride in patients with bronchial disease. Caution is advised in using histamine in such patients and in those with a history of bronchial asthma. Histamine Dihydrochloride has not been approved for unlabeled use as gastric acid stimulus or for detecting bronchial hyperactivity.

Source: US FDA prescribing information

Side effects

Large doses of histamine may precipitate systemic reactions. These reactions may include flushing, dizziness, headache, bronchial constriction, urticaria, asthma, marked hypotension or hypertension, abdominal cramps, vomiting, metallic taste, local or generalized allergic manifestations. An antihistamine preparation may be given orally, I.M. or I.V. to prevent or ameliorate systemic reactions to the drug. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet. Epinephrine Dosage: ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.

Source: US FDA prescribing information

Interactions

. Drug Interactions: Certain medications may lessen the skin test wheal and erythema responses elicited by histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing. 7 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 7,8 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. 9 The physician must determine whether the risk of severe depression occurring in patients who discontinue their medication outweighs the benefits that could be obtained from skin testing. Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 10

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Histamine, sorted by availability.

MedicineManufacturerRegisterAvailability
histamine positive skin test control 1.375 mg/5 mL injectionIntradermal Cold chainALK-AbelloUS FDAAvailable on request
Histamine Positive Skin Test Control 2.75 mg/mL topical solutionPercutaneous Cold chainALK-AbelloUS FDAAvailable on request
Positive Skin Test Control - Histamine 30 mg/5 mL injectionPercutaneous Cold chainJubilant HollisterStierIndiaUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Indian manufacturers are highlighted.

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 25 April 1939Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Histamine available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Histamine and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Jubilant HollisterStier.

What brand names does Histamine have?

The catalogue lists 3 brand names for Histamine, including Histamine Positive Skin Test Control, histamine positive skin test control, Positive Skin Test Control - Histamine.

Is Histamine approved by the US FDA?

Yes. The US FDA first approved Histamine on 25 April 1939, according to Drugs@FDA.

Is Histamine authorised in the European Union?

Yes. Histamine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Histamine need cold chain shipping?

At least one listed presentation of Histamine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Histamine in?

Histamine is classified under ATC code L03AX14 (Histamine).

References

  1. Positive Skin Test Control - Histamine prescribing information (Jubilant HollisterStier). U.S. National Library of Medicine, DailyMed. Retrieved 3 April 2026
  2. Ceplene: European public assessment report (EPAR). European Medicines Agency. Retrieved 19 April 2023

Request Histamine for export supply

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