Cloperastine

Cough suppressant with central and peripheral action

ATC code: R05DB21

Updated 24 Sep 2026 · Methodology

Indications

Dry cough

Adjunct

Cloperastine is the most popular dry cough remedy in Spain: Flutox, Sekisan and Cinfatusina sit in every pharmacy. The AEMPS ficha técnica frames the indication as treatment of unproductive forms of cough – irritative and nervous – in adults and children from 2 years, 10 ml three times a day for adults. The evidence base for cough suppressants as a class is weak: the 2014 Cochrane review of over-the-counter cough medicines found no convincing data in their favor, and there are no separate large trials of cloperastine. So the sensible frame is this: a few days for an exhausting dry cough that prevents sleep, and stopping as soon as the cough turns productive. The ficha asks for reassessment if cough lasts beyond a week and reminds about drowsiness at the wheel.

Sources

ICD-10: R05 · ICD-11: MD12

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Productive cough

Not recommended

A wet cough should not be suppressed: it carries sputum out of the bronchi, and that is its job. The AEMPS ficha técnica gives cloperastine only unproductive cough, and directly advises against combining it with other cough suppressants without a doctor. When sputum is present and the cough reflex is muffled, secretions stay in the airways – hence the caution in people with asthma and chronic bronchitis. The practical guide: once the cough turns wet, the suppressant is stopped. Cough beyond three weeks, blood in sputum, breathlessness, purulent sputum or fever call for examination, not a second bottle of syrup. If cloperastine was prescribed for a productive cough, consider seeking a second opinion.

Sources

ICD-10: R05 · ICD-11: MD12

Common cold

Not recommended

Cough syrup for a child with a cold is the most habitual autumn purchase in a Spanish pharmacy. Cloperastine is contraindicated under 2 years directly in the AEMPS ficha técnica. The numbers then speak for themselves: Spanish toxicologists in Anales de Pediatría 2022 analyzed child poisonings with cold remedies and showed that their benefit is unproven while the toxicity is real. The Guía-ABE chapter on upper respiratory catarrh puts it the same way: none of these drugs relieves symptoms meaningfully. The 2018 Cochrane review of honey for acute cough in children found data no worse than for pharmacy syrups – honey over the age of one reduces cough frequency. In a child's cold what works is fluids, saline nasal rinsing and time. If cough syrup was prescribed to a child under 2, consider seeking a second opinion from a pediatrician.

Sources

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Cloperastine suppresses the cough centre in the medulla but, unlike codeine and dextromethorphan, does not depress breathing and creates no opioid dependence. A peripheral action is added to the central one: an antispasmodic effect on the bronchi and weak antihistamine activity, because the molecule is related to antihistamines. The AEMPS ficha técnica warnings grow from the same root: drowsiness and anticholinergic effects, which is why the drug is used with caution in glaucoma, prostate enlargement and urinary retention. Cloperastine is registered in Spain, Italy and Japan but absent from the United States and most of the EU – it is a national product, not an international standard for treating cough.

Safety

Contraindications

Hypersensitivity to cloperastine
Hypersensitivity to antihistamines
Concomitant monoamine oxidase inhibitors
Pregnancy and breastfeeding
Children under 2 years

Serious adverse effects

Anaphylactic and anaphylactoid reactions, urticaria
Dystonia and tremor
Urinary retention in people with prostate enlargement
Worsening of glaucoma

Common adverse effects

Drowsiness
Dry mouth
Nausea
Dizziness

Pregnancy: can you take Cloperastine?

Animal studies found no teratogenic effect or fetotoxicity, but clinical experience is lacking. The ficha técnica prohibits use in pregnancy.

Breastfeeding: can you take Cloperastine?

Whether cloperastine passes into breast milk is unknown, so it is not prescribed while breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions8 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

CriticalIMAOclass named in the label
«Pacientes que estén en tratamiento con inhibidores de la monoaminooxidasa (IMAO).»
AEMPS, section 4.3 · Open on CIMA
antidepresivos tricíclicosclass named in the label
«Anticolinérgicos (antiparkinsonianos, antidepresivos tricíclicos, neurolépticos, IMAO). Los antihistamínicos producen potenciación de la acción antimuscarínica.»
AEMPS, section 4.5 · Open on CIMA
antihistamínicosclass named in the label
«Alcohol. Por su carácter antihistamínico, la cloperastina puede incrementar los efectos del alcohol.»
AEMPS, section 4.5 · Open on CIMA
antipsicóticosclass named in the label
«Sedantes (hipnóticos, analgésicos opioides, barbitúricos, benzodiazepinas, antipsicóticos) y, en general, de los fármacos depresores centrales.»
AEMPS, section 4.5 · Open on CIMA
barbitúricosclass named in the label
«Sedantes (hipnóticos, analgésicos opioides, barbitúricos, benzodiazepinas, antipsicóticos) y, en general, de los fármacos depresores centrales.»
AEMPS, section 4.5 · Open on CIMA
benzodiazepinasclass named in the label
«Sedantes (hipnóticos, analgésicos opioides, barbitúricos, benzodiazepinas, antipsicóticos) y, en general, de los fármacos depresores centrales.»
AEMPS, section 4.5 · Open on CIMA
depresores del SNCclass named in the label
«Sedantes (hipnóticos, analgésicos opioides, barbitúricos, benzodiazepinas, antipsicóticos) y, en general, de los fármacos depresores centrales.»
AEMPS, section 4.5 · Open on CIMA
opioidesclass named in the label
«Sedantes (hipnóticos, analgésicos opioides, barbitúricos, benzodiazepinas, antipsicóticos) y, en general, de los fármacos depresores centrales.»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Cloperastine used for?

Cloperastine is evaluated for the following indications with varying evidence strength: Dry cough (evidence tier C), Productive cough (evidence tier D), Common cold (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Cloperastine?

Common side effects of Cloperastine (≥ 1 in 100): Drowsiness, Dry mouth, Nausea, Dizziness. See the Safety section for uncommon and serious reactions.

Is Cloperastine safe during pregnancy?

Animal studies found no teratogenic effect or fetotoxicity, but clinical experience is lacking. The ficha técnica prohibits use in pregnancy.

Is Cloperastine compatible with breastfeeding?

Whether cloperastine passes into breast milk is unknown, so it is not prescribed while breastfeeding.

Who should not take Cloperastine?

Cloperastine is contraindicated in: Hypersensitivity to cloperastine; Hypersensitivity to antihistamines; Concomitant monoamine oxidase inhibitors; Pregnancy and breastfeeding; Children under 2 years. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 04/13/2026

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