Rupatadine

Pronunciation: roo-PAT-a-deen.

Generic name
rupatadine
Drug class
Second-generation (non-sedating) antihistamine with additional platelet-activating-factor (PAF) antagonist activity
Form
Tablet (10 mg); oral solution (1 mg/mL) for younger children where authorised
Route
Oral
Legal status
Prescription-only (where authorised; not approved/marketed in the United States)

Availability and supply rules vary by country

Trade names by country: United Kingdom · Canada · Australia

Australia: Rupafin (4) · Full directory

What rupatadine is and how it works

Rupatadine is a prescription antihistamine used to relieve the symptoms of allergic rhinitis (hay fever-type allergies) and chronic urticaria (long-term hives). It belongs to the newer, generally non-sedating generation of antihistamines, though individual sedation can still occur. (1)

Take rupatadine exactly as your prescriber or the product labelling directs. It is not approved or sold in the United States; availability and the exact licensed age range vary by country.

Mechanism of action: how rupatadine works

Rupatadine is a long-acting, selective peripheral histamine H1-receptor antagonist that also has platelet-activating-factor (PAF) antagonist activity, contributing to its anti-allergic effect. (1)

What rupatadine is used for

Allergic rhinitis

Used to relieve nasal and eye symptoms of seasonal and year-round allergic rhinitis, such as sneezing, runny or blocked nose, and itchy/watery eyes. (1) (3)

Chronic urticaria

Used to relieve the itching and hives (wheals) of chronic urticaria. (1) (3)

Before taking rupatadine

Do not take / not appropriate for

  • Do not take rupatadine if you have had an allergic reaction to rupatadine or any of its ingredients. (all countries) (1)
  • Do not take rupatadine tablets if you have a rare hereditary condition such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, because of an excipient in the tablet. (United Kingdom) (1)

Tell your clinician about

  • Any heart rhythm problems, a known prolonged QT interval, low blood potassium, or other conditions that could predispose to abnormal heart rhythm.
  • Any kidney or liver problems -- rupatadine is not recommended in these groups because there is limited clinical experience.
  • All other medicines you take, especially azole antifungals (e.g. ketoconazole) or macrolide antibiotics (e.g. erythromycin), and whether you regularly drink grapefruit juice.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1)

How to take rupatadine

  • Swallow the tablet with or without food, at the dose and frequency your prescriber or the product labelling directs.
  • Avoid grapefruit juice while taking rupatadine -- it can substantially increase rupatadine levels in the body.
  • Response to antihistamines varies between individuals -- be cautious about driving or operating machinery until you know how rupatadine affects you.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it when you remember unless it is nearly time for your next dose -- do not take a double dose to make up for a missed one. Ask your prescriber or pharmacist if unsure.

Overdose

Seek urgent medical advice or emergency care if too much rupatadine has been taken, particularly in children, or if symptoms such as marked drowsiness or a fast or abnormal heartbeat occur. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Drowsiness (somnolence) -- the most commonly reported side effect.

What to notice: Drowsiness (somnolence) -- the most commonly reported side effect.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Fatigue and general weakness (asthenia).

What to notice: Fatigue and general weakness (asthenia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Dry mouth and dizziness.

What to notice: Dry mouth and dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of an abnormal heart rhythm — high caution

Symptoms: Palpitations, a fast or irregular heartbeat, fainting, or severe dizziness -- particularly relevant if you have a known heart rhythm condition, low blood potassium, or take other medicines that affect heart rhythm.

Action: Tell your prescriber promptly if these occur; this caution applies especially to patients with pre-existing QT-interval prolongation or proarrhythmic risk factors. (1)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (1)

Interactions

  • Grapefruit juice increases rupatadine levels in the body by roughly 3.5-fold -- it is best avoided while taking rupatadine. (1)
  • Strong CYP3A4-inhibitor medicines, such as ketoconazole (an antifungal) and erythromycin (an antibiotic), significantly raise rupatadine levels and this combination is generally avoided; moderate CYP3A4 inhibitors should be used with caution. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

It is preferable to avoid rupatadine during pregnancy, as data are limited. Discuss alternatives with your prescriber if pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)

Breastfeeding

It is not known whether rupatadine passes into breast milk, so caution is advised -- discuss with your prescriber before use while breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Authorised age range varies by country and formulation: in the UK, tablets are for those over 12 years, with a separate oral solution used in younger children; in Canada, the product is authorised from 2 years of age using age-appropriate dosing. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed, but caution is warranted given the cardiac and renal/hepatic considerations that become more common with age. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not recommended in patients with liver impairment, as there is no clinical experience in this group per the UK SmPC. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not recommended in patients with kidney impairment, as there is no clinical experience in this group per the UK SmPC. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Review of heart rhythm risk factors (personal/family history, other QT-prolonging medicines, potassium levels if relevant)
  • Review of kidney and liver function history
  • Review of all other medicines, including antifungals, macrolide antibiotics, and grapefruit juice intake

During treatment

  • Monitor for excessive drowsiness, especially before driving or operating machinery.
  • Monitor for palpitations or other cardiac symptoms in at-risk patients.
(1)

Storage

Store below 30°C, in the original packaging, protected from light and moisture, out of reach and sight of children.

Professional information

Clinician-facing context only, sourced from the current UK emc SmPC and Health Canada product monograph; verify against the current full label in the relevant jurisdiction before prescribing.

United Kingdom

Indication: Allergic rhinitis and chronic urticaria

Dose summary: 10 mg orally once daily, with or without food, for adults and adolescents over 12 years. Not recommended in renal or hepatic impairment due to lack of clinical experience.

Renal context: Not recommended -- no clinical experience in renal impairment per the UK SmPC. (1)

Canada

Indication: Allergic rhinitis and chronic spontaneous urticaria

Dose summary: Authorised from 2 years of age; dose and formulation (tablet vs. oral solution) depend on age and weight per the product monograph.

Renal context: Not established in the source reviewed for this dossier. (3)

Mechanism of action

Hepatic guidance

Not recommended in hepatic impairment; no clinical experience described in the UK SmPC.

Overdose note

Overdose may cause somnolence and, based on the drug's cardiac caution profile, could theoretically be associated with cardiac effects in susceptible individuals; manage supportively with monitoring, including ECG monitoring where clinically indicated. (1)

Frequently asked questions

Is rupatadine available in the United States?

No. Rupatadine has not been approved by the FDA and is not sold in the United States. It is authorised in the United Kingdom, across EU member states, in Canada, and has undergone TGA evaluation in Australia; New Zealand availability could not be confirmed. (6) (1) (2) (3) (4)

Can I drink grapefruit juice while taking rupatadine?

It is best to avoid grapefruit juice, since it can increase rupatadine levels in the body by around 3.5-fold. (1)

Who should be cautious about taking rupatadine?

Use caution if you have a known heart-rhythm condition (such as QT-interval prolongation) or uncorrected low potassium, since rupatadine carries a cardiac caution for these groups, even though studies at up to 10 times the normal dose showed no measurable effect on the heart's electrical activity. It is also not recommended if you have kidney or liver impairment, since there is limited clinical experience in these groups. (1)

What is the mechanism of action of rupatadine?

Rupatadine is a long-acting, selective peripheral histamine H1-receptor antagonist that also has platelet-activating-factor (PAF) antagonist activity, contributing to its anti-allergic effect. (1)

What is the generic name of Rupatadine?

The generic name is rupatadine. (1) (6)

What class of drug is rupatadine?

Rupatadine is classed as: Second-generation (non-sedating) antihistamine with additional platelet-activating-factor (PAF) antagonist activity. (1) (6)

References

  1. Rupatadine 10mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-29 · source 1
  2. Rupatadine -- list of nationally authorised medicinal productsEuropean Medicines Agency (EMA) -- PSUSA (periodic safety update single assessment) list of nationally authorised medicinal products · European Union · accessed 2026-07-29 · source 2
  3. RUPALL (rupatadine) Product MonographHealth Canada product monograph (RUPALL / rupatadine generics) · Canada · accessed 2026-07-29 · source 3
  4. Australian Public Assessment Report (AusPAR) for Rupatadine (Rupafin)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4
  5. Medsafe product/data-sheet search for rupatadineMedsafe (New Zealand regulator) -- search attempt · New Zealand · accessed 2026-07-29 · source 5
  6. Rupatadine -- US regulatory status checkCross-source check (DailyMed direct search; drugs.com international database; general regulatory literature) · United States · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient rupatadine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United Kingdom

  • Rupatadine (generic) (1)MHRA licensed emc smpc confirmed current · 10 mg tablet, 1 mg/mL oral solution · various generic manufacturers

Canada

  • RUPALL

Australia

  • Rupafin (4)TGA AusPAR evaluated 2011-05-18 · 10 mg tablet · iNova Pharmaceuticals (Australia) Pty Ltd
View brands in additional countries.

European Union

Rupafin (and national equivalents, e.g. Alergoliber) (2)

This page provides general reference information about rupatadine and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber, and availability varies significantly by country.

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