Table 2.
Drug–event combinations of montelukast and psychiatric events
| Reaction HLT | Reports (N) | PRR (95% CI) |
|---|---|---|
| Behaviour and socialisation disturbances | 328 | 16.0 (14.4–17.8) |
| Parasomnias | 252 | 49.5 (43.3–56.6) |
| Anxiety symptoms | 249 | 6.4 (5.7–7.2) |
| Emotional and mood disturbances NEC | 247 | 6.9 (6.1–7.7) |
| Suicidal and self-injurious behaviour | 219 | 7.1 (6.3–8.1) |
| Abnormal behaviour NEC | 211 | 9.7 (8.5–11.1) |
| Disturbances in initiating and maintaining sleep | 163 | 10.4 (8.9–12.1) |
| Depressive disorders | 142 | 10.2 (8.6–12.0) |
| Fear symptoms and phobic disorders (including social phobia) | 72 | 27.5 (21.5–35.1) |
| Mood alterations with depressive symptoms | 67 | 8.0 (6.3–10.2) |
| Sleep disorders NEC | 66 | 7.0 (5.5–9.0) |
| Increased physical activity levels | 63 | 3.4 (2.7–4.3) |
| Speech articulation and rhythm disturbances | 61 | 6.3 (4.9–8.1) |
| Fluctuating mood symptoms | 59 | 20.6 (15.8–26.9) |
| Attention deficit and disruptive behaviour disorders | 33 | 14.8 (10.4–21.0) |
| Tic disorders | 32 | 8.1 (5.7–11.5) |
| Mood disorders NEC | 32 | 2.5 (1.7–3.5) |
| Obsessive-compulsive disorders and symptoms | 32 | 14.8 (10.4–21.3) |
| Panic attacks and disorders | 30 | 10.7 (7.4–15.5) |
| Thinking disturbances | 28 | 15.4 (10.5–22.7) |
| Confusion and disorientation | 25 | 2.0 (1.3–2.9) |
| Sleep disturbances NEC | 22 | 4.6 (3.0–7.0) |
| Affect alterations NEC | 21 | 9.3 (6.0–14.4) |
| Personality disorders NEC | 20 | 23.3 (14.6–37.1) |
| Psychotic disorder NEC | 18 | 3.2 (2.0–5.1) |
| Educational issues | 18 | 26.0 (15.8–42.6) |
| Psychiatric elimination disorders | 17 | 12.7 (7.8–20.8) |
| Criminal activity | 12 | 12.4 (6.9–22.3) |
| Anxiety disorders NEC | 10 | 14.8 (7.8–28.3) |
| Stereotypies and automatisms | 9 | 4.4 (2.3–8.5) |
| Impulse control disorders | 7 | 6.1 (2.9–12.9) |
CI confidence interval, HLT high-level term, NEC not elsewhere classified, PRR proportional reporting ratio