Drug
Azelastine Hcl
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Sneezing | 21 | 13.8 | 14.0 | signal |
| 2 | Sinus Disorder | 18 | 13.3 | 13.5 | signal |
| 3 | Seasonal Allergy | 11 | 11.5 | 11.5 | signal |
| 4 | Product Use Complaint | 11 | 10.4 | 10.5 | signal |
| 5 | Drug Effective For Unapproved Indication | 16 | 8.1 | 8.1 | signal |
| 6 | Blood Count Abnormal | 8 | 7.6 | 7.7 | signal |
| 7 | Body Height Decreased | 5 | 6.8 | 6.8 | signal |
| 8 | Increased Tendency To Bruise | 4 | 6.4 | 6.4 | signal |
| 9 | Product Prescribing Issue | 8 | 5.8 | 5.8 | signal |
| 10 | Thyroid Disorder | 6 | 5.7 | 5.7 | signal |
| 11 | Middle Insomnia | 7 | 5.5 | 5.6 | signal |
| 12 | Tooth Disorder | 8 | 5.3 | 5.3 | signal |
| 13 | Anosmia | 5 | 5.1 | 5.1 | signal |
| 14 | Pharyngeal Oedema | 5 | 4.7 | 4.7 | signal |
| 15 | Expired Product Administered | 10 | 4.4 | 4.5 | signal |
| 16 | Malignant Melanoma | 4 | 4.4 | 4.4 | signal |
| 17 | Product Dose Omission | 19 | 4.2 | 4.3 | signal |
| 18 | Internal Haemorrhage | 3 | 3.9 | 3.9 | no signal |
| 19 | Eye Pruritus | 8 | 3.6 | 3.6 | signal |
| 20 | Metastases To Central Nervous System | 3 | 3.4 | 3.4 | no signal |
| 21 | Injection Site Haematoma | 3 | 3.0 | 3.0 | no signal |
| 22 | Incorrect Dose Administered By Device | 4 | 2.3 | 2.3 | no signal |
| 23 | Application Site Pain | 3 | 2.0 | 2.0 | no signal |
| 24 | Injection Site Bruising | 10 | 1.9 | 1.9 | no signal |
| 25 | Injection Site Mass | 4 | 1.6 | 1.6 | no signal |
| 26 | Wrong Technique In Device Usage Process | 4 | 1.3 | 1.3 | no signal |
| 27 | Device Leakage | 3 | 1.0 | 1.0 | no signal |