Safety of sublingual immunotherapy with monomeric allergoid in adults: multicenter post-marketing surveillance study

Allergy. 2001 Oct;56(10):989-92. doi: 10.1034/j.1398-9995.2001.00181.x.


Background: Sublingual immunotherapy (SLIT) appears to be acceptably safe in clinical trials, but post-marketing data are needed to provide essential information. This study specifically evaluated the safety of commercial SLIT in adult patients in a post-marketing phase.

Methods: A total of 198 patients (83 male, 115 female, mean age 24.4 years) receiving SLIT for respiratory allergy were followed up for 3 years by a specific questionnaire for side-effects. SLIT (LAIS, Lofarma SpA, Milan, Italy), a monomeric allergoid in tablets, was administered, in association with drug therapy, pre- or pre-coseasonally for pollen and continuously for mites. The average duration was 12-36 months, and the total of doses was about 32 800. Side-effects were grouped as ocular, gastrointestinal, rhinitis, asthma, urticaria, edema of tongue/lips, and anaphylaxis. The severity was graded as low (no need for treatment or dose adjusting, no interference with activities), moderate (interference with activities/need for drugs/SLIT discontinuation), and severe (life-threatening/hospitalization/emergency care).

Results: Seventeen events corresponding to 7.5% of patients and 0.52 per 1000 doses were reported. Seven episodes of rhinitis (two in two patients), three of oral itching, and one of abdominal pain were self-limiting. Two cases of urticaria and two of abdominal pain/nausea were controlled by a temporary dose-adjustment, and one case of urticaria and conjunctivitis required oral antihistamines. Medical intervention was needed in six patients only during a 3-year period.

Conclusion: The results of this study, performed in a real situation of clinical practice, confirm the satisfactory safety profile of SLIT.

Publication types

  • Multicenter Study

MeSH terms

  • Administration, Sublingual
  • Adolescent
  • Adult
  • Allergens / administration & dosage
  • Allergens / adverse effects*
  • Allergoids
  • Desensitization, Immunologic / adverse effects*
  • Desensitization, Immunologic / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Plant Extracts / administration & dosage
  • Plant Extracts / adverse effects*
  • Product Surveillance, Postmarketing
  • Respiratory Hypersensitivity / drug therapy*
  • Tablets
  • Treatment Outcome


  • Allergens
  • Allergoids
  • Plant Extracts
  • Tablets