Table 3.
Most common adverse drug reactions (ADRs) after montelukast reported to the Netherlands Pharmacovigilance Centre Lareb and the WHO Global ICSR database VigiBase®
| Adverse drug reaction | Total number of reports at VigiBase® | RORa VigiBase® (95% CI) | Number of reports in children <19 year at VigiBase® | RORa VigiBase® in children <19y (95% CI) | Total number of reports at Lareb | RORa Lareb (95% CI) | Number of reports in children <19 year at Lareb | RORa Lareb in children <19 year (95% CI) |
|---|---|---|---|---|---|---|---|---|
| Depression | 1188 | 6.93 (6.54–7.36) | 493 | 20.52 (18.65–22.58) | 5 | 1.91 (0.79–4.62) | – | – |
| Headache | 1128 | 1.85 (1.75–1.97) | 371 | 1.91 (1.72–2.12) | 37 | 2.26 (1.61–3.19) | 17 | 3.18 (2.66–3.70) |
| Aggression | 1101 | 24.99 (23.49–26.59) | 808 | 29.77 (27.54–32.18) | 11 | 9.27 (5.06–16.99) | 7 | 12.02 (11.24–12.80) |
| Suicidal ideation | 1047 | 20.43 (19.18–21.76) | 495 | 38.27 (34.68–42.22) | 1 | – | – | – |
| Insomnia | 1020 | 5.08 (4.77–5.41) | 417 | 11.15 (10.07–12.35) | 15 | 3.45 (2.05–5.81) | 7 | 4.60 (3.83–5.38) |
| Anxiety | 948 | 5.11 (4.79–5.46) | 468 | 16.99 (15.41–18.72) | 6 | 2.79 (1.24–6.26) | 2 | – |
| Abnormal behavior | 892 | 34.05 (31.79–36.46) | 643 | 17.64 (15.99–19.46) | 7 | 12.02 (5.64–25.61) | 7 | 8.56 (7.79–9.34) |
| Nightmares | 749 | 22.48 (20.87–24.21) | 448 | 78.04 (69.95–87.07) | 25 | 19.29 (12.75–29.17) | 13 | 56.72 (56.09–57.35) |
| Dyspnea | 649 | 1.30 (1.20–1.41) | 120 | 1.14 (0.95–1.36) | 13 | 1.47 (0.84–2.56) | – | — |
| Rash | 540 | 0.65 (0.59–0.71) | 161 | 0.31 (0.26–0.36) | 17 | 1.77 (1.09–2.89) | 7 | 1.28 (0.51–2.05) |
| Abdominal pain | 511 | 1.81 (1.66–1.98) | 222 | 2.24 (1.95–2.56) | 15 | 2.24 (1.33–3.77) | 8 | 3.67 (2.95–4.40) |
| Dizziness | 541 | 0.89 (0.82–0.97) | 97 | 0.72 (0.59–0.88) | 12 | 0.94 (0.53–1.68) | – | – |
| Myalgia | 352 | 1.66 (1.49–1.84) | 58 | 1.57 (1.21–2.03) | 12 | 1.26 (0.71–2.25) | – | – |
| Muscle spasms | 291 | 2.44 (2.17–2.74) | 57 | 3.98 (3.06–5.17) | 10 | 2.87 (1.53–5.40) | – | – |
| Nausea | 557 | 0.61 (0.56–0.66) | 104 | 0.56 (0.46–0.68) | 10 | 0.65 (0.35–1.23) | 4 | 1.17 (0.16–2.17) |
Disclaimer: This publication contains information obtained from UMC through https://vigilyze.who-umc.org (restricted access), accessed at 03‐11‐2016. The information comes from a variety of sources, and the likelihood that the suspected adverse reaction is drug‐related is not the same in all cases, The information shown in this article does not represent the opinion of the World Health Organization. For more information see http://www.who-umc.org/graphics/25300.pdf
ROR computed when more than two cases. The numerator is the number of cases in which montelukast was used and a specific ADR was reported divided by the number of cases using montelukast in which this ADR was not reported. The denominator is the number of pediatric cases using other suspected drugs reporting a specific ADR divided by the number of pediatric cases using other suspected drugs without reporting that specific ADR. The ROR was calculated for the entire group as well as for children.