Second-generation H1-antihistamine + PAF antagonist Pregnancy: Limited data in pregnant women; animal studies do not indicate direct or indirect harmful effects, but as a precautionary measure it is preferable to AVOID use during pregnancy. Breastfeeding: rupatadine is excreted in animal milk and it is unknown whether it is excreted in human breast milk — decide whether to discontinue breastfeeding or the drug. Fertility: no clinical data; animal studies showed significant reduction of fertility at exposures higher than those seen in humans at the maximum therapeutic dose.

Rupatadine

Brand names: Rupafin

Rupatadine is a non-sedating oral antihistamine used to treat allergic rhinitis and chronic urticaria.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg (one tablet)

Route: Oral, with or without food

Frequency: Once a day

Applies to adults and adolescents over 12 years of age. Elderly: rupatadine should be used with caution in elderly people (65 years and older) — although no overall differences in effectiveness or safety were observed in clinical trials, higher sensitivity of some older individuals cannot be excluded. Paediatric: Rupatadine 10 mg Tablets are NOT recommended for use in children below age 12; in children aged 2 to 11 years the SPC recommends rupatadine 1 mg/ml oral solution, but gives no numeric dose for it in this section — verify any paediatric dosing against a children's formulary. Renal or hepatic insufficiency: as there is no clinical experience in patients with impaired kidney or liver function, use of the 10 mg tablets is at present NOT recommended in these patients. Grapefruit juice should not be taken simultaneously (increases systemic exposure 3.5-fold). Use with caution in patients with known QT prolongation, uncorrected hypokalaemia, or ongoing proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischaemia. Contains lactose monohydrate — not suitable for patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Source: eMC SPC for Rupatadine 10 mg Tablets.

Dose adjustments

Renal

No dose adjustment is given — the SPC states that, as there is no clinical experience in patients with impaired kidney function, use of rupatadine 10 mg tablets is at present not recommended in these patients (the same applies to hepatic impairment).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Somnolence (9.4%)
Headache (6.9%)
Fatigue (3.1%) and asthenia (1.5%)
Dry mouth (1.2%)
Dizziness (1.03%); also common: pharyngitis, rhinitis, increased appetite, disturbance in attention, cough, dry throat, epistaxis, nasal dryness, oropharyngeal pain. Rare post-authorisation: tachycardia and palpitations, and hypersensitivity reactions including anaphylactic reactions, angioedema and urticaria

Interactions

Potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, nefazodone) — co-administration should be avoided (ketoconazole increased rupatadine systemic exposure 10-fold)
Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem) — use with caution (erythromycin increased exposure 2-3 fold)
Grapefruit juice — increased systemic exposure 3.5-fold; should not be taken simultaneously
Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride) — dose adjustment could be required, as rupatadine may increase their plasma concentrations
Other metabolised drugs with narrow therapeutic windows — caution on co-administration

Clinical monograph

How it works

It is a long-acting selective histamine H1-receptor antagonist with additional platelet-activating factor antagonism, reducing the symptoms of allergic and histamine-mediated reactions.

Prescribing in practice

Although classed as non-sedating, drowsiness can still occur, and concomitant alcohol or CNS depressants may add to this effect.
It is metabolised by CYP3A4, so caution is advised with potent enzyme inhibitors such as certain azole antifungals and macrolides.
Grapefruit juice may increase exposure and should be avoided.

Monitoring

No routine monitoring is required; review if allergic symptoms remain inadequately controlled.

Counselling the patient

If it makes you drowsy, avoid driving or operating machinery and be careful with alcohol.
Avoid grapefruit juice while taking this medicine.
It can be taken regularly to help control ongoing allergy symptoms.

Evidence & guidelines

Use is supported by its established role in allergic rhinitis and chronic urticaria; consult current prescribing references for interaction details.

Reference: SmPC; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways