Dimenhydrinate
Regulatory sources consulted
- openfda-label-b9559b5b-f577-4930-ac13-ceb79a7a9c05
- ANSM RCP for NAUSICALM (CIS: 69806008)
- PubMed PMID:36250781 ↗
- PubMed PMID:39976040 ↗
- General clinical pharmacology knowledge
- OpenFDA · A04AD05
- ANSM BDPM · CIS 69806008 ↗
- RxNorm rxcui 3444 ↗
Approved indications
- Prevention and treatment of symptoms associated with motion sickness, such as nausea, vomiting, and/or dizziness.
- Short-term symptomatic treatment of nausea and vomiting not accompanied by fever.
Contraindications
Absolute
- Hypersensitivity to dimenhydrinate or other antihistamines.
- Risk of angle-closure glaucoma.
- Risk of urinary retention related to urethroprostatic disorders.
Relative
- Children under 2 years of age (unless directed by a doctor).
Clinical warnings
- Major warning · May cause marked drowsiness. Alcohol, sedatives, and tranquilizers may increase this effect. Use caution when driving a motor vehicle or operating machinery. — FDA
- Use with caution in patients with bronchial asthma, chronic breathing problems (emphysema, chronic bronchitis), or difficulty in urination due to an enlarged prostate gland. — FDA
- Cases of abuse and dependence have been reported, mainly in adolescents and young adults for recreational purposes. — ANSM SPC
Drug interactions
- HighAlcoholV03AB16
Mechanism: Potentiation of the sedative effect of the H1 antihistamine. Impaired alertness can make driving and using machinery dangerous.
Recommendation: Avoid consuming alcoholic beverages and medications containing alcohol during treatment.
ANSM SPC
- HighCNS depressants (benzodiazepines, opioids, barbiturates)
Mechanism: Increased central nervous system depression.
Recommendation: Use with caution and monitor for increased sedation and respiratory depression.
ANSM SPC
- ModerateAtropinic substances (tricyclic antidepressants, antiparkinsonian drugs)
Mechanism: Addition of atropinic adverse effects such as urinary retention, constipation, and dry mouth.
Recommendation: Monitor for the appearance or worsening of anticholinergic effects.
ANSM SPC
Adverse events
Common (≥1%)
drowsiness · sedation · dry mouth · dizziness · blurred vision · accommodation disorders
Rare but serious
hallucinations · mental confusion · seizures · agranulocytosis · hemolytic anemia · anaphylaxis · extrapyramidal symptoms (in children)
Pregnancy and lactation
Pregnancy: Use only if necessary. In the 3rd trimester, limit to occasional use. If used at the end of pregnancy, monitor the newborn's neurological and digestive functions. Lactation: Not recommended for use due to passage into breast milk and its sedative and atropinic properties.
Recent literature (PubMed)
Revisión sistemática Cochrane que evaluó la efectividad de los antihistamínicos para la prevención y el tratamiento de la cinetosis. Se incluyeron nueve ECA con 658 participantes. Los resultados sobre la eficacia fueron conflictivos, lo que subraya la necesidad de más investigación de alta calidad, aunque los antihistamínicos se han utilizado durante décadas para esta indicación.
Revisión sistemática sobre el mal uso de medicamentos de venta libre, incluido el dimenhidrinato. El análisis de 46 estudios encontró que el abuso de antihistamínicos puede inducir síntomas psicóticos agudos, como paranoia y alucinaciones. El estudio destaca la necesidad de una mayor concienciación e intervenciones específicas para abordar el mal uso de estos fármacos.