Table 4 Nervous system disorders associated with individual H1-antihistamines. (HLGT: high level group term, PT: preferred term,–: not a positive signal, n: total number of AE reports for individual drug)
HLGT | PT | Cetirizine (n = 1659) | Levocetirizine (n = 1488) | Loratadine (n = 582) | Desloratadine (n = 112) | Fexofenadine (n = 576) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | ROR (95% CI) | PRR | χ2 | N | ROR (95% CI) | PRR | χ2 | N | ROR (95% CI) | PRR | χ2 | N | ROR (95% CI) | PRR | χ2 | N | ROR (95% CI) | PRR | χ2 | ||
Central nervous system vascular disorders | Carotid artery dissection | 3 | 11.1(3.5–34.9) | 11·1 | 27·0 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Reversible cerebral vasoconstriction syndrome | 11 | 8.2(4.5–14.9) | 8·2 | 68·7 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Cerebral vasoconstriction | 3 | 6.3(2.0-19.7) | 6·3 | 13·2 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Subarachnoid haemorrhage | 26 | 3.8(2.6–5.6) | 3·8 | 53·1 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Lacunar infarction | – | – | – | – | 3 | 7.1(2.3–22.2) | 7·1 | 15·7 | – | – | – | – | – | – | – | – | – | – | – | – | |
Transient ischaemic attack | – | – | – | – | – | – | – | – | – | – | – | – | 5 | 7.0(2.9–16.8) | 7·0 | 25·3 | – | – | – | – | |
Cranial nerve disorders (excl neoplasms) | Facial paresis | 7 | 3.2(1.5–6.7) | 3·2 | 10·4 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Demyelinating disorders | Demyelination | 10 | 4.5(2.4–8.3) | 4·5 | 26·5 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Neurological disorders of the eye | Hemianopia homonymous | 3 | 7.7(2.5–24.2) | 7·7 | 17·3 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Neuromuscular disorders | Anticholinergic syndrome | 14 | 15.3(9.0-26.1) | 15·3 | 181·5 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Peripheral neuropathies | Guillain-Barre syndrome | 7 | 2.5(1.2–5.3) | 2·5 | 6·5 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Headaches | Sinus headache | 7 | 2.8(1.3–5.8) | 2·8 | 7·8 | 9 | 7.9(4.1–15.3) | 7·9 | 53·7 | 8 | 3.4(1.7–6.9) | 3·4 | 13·6 | – | – | – | – | 15 | 7.3(4.4–12.1) | 7·3 | 80·4 |
Migraine with aura | – | – | – | – | – | – | – | – | – | – | – | – | 3 | 35.0(11.2–109.0) | 34·8 | 98·3 | – | – | – | – | |
Movement disorders (incl parkinsonism) | Psychomotor hyperactivity | 50 | 5.3(4.0–7.0) | 5·2 | 170·0 | – | – | – | – | 28 | 3.2(2.2–4.6) | 3·2 | 41·5 | – | – | – | – | 23 | 3.0(2.0-4.4) | 2·9 | 29·4 |
Dystonia | 28 | 3.8(2.6–5.5) | 3·8 | 57·1 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Parkinsonism | – | – | – | – | – | – | – | – | – | – | – | – | 5 | 20.8(8.6–50.2) | 20·6 | 93·3 | – | – | – | – | |
Mental impairment disorders | Amnestic disorder | – | – | – | – | – | – | – | – | – | – | – | – | 4 | 256.3(94.8-692.6) | 254·6 | 988·2 | – | – | – | – |
Amnesia | – | – | – | – | – | – | – | – | – | – | – | – | 5 | 2.9(1.2-7.0) | 2·9 | 6·2 | – | – | – | – | |
Neurological disorders NEC | Hyperpathia | 6 | 160.5(64.1-401.8) | 160·4 | 722·3 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Hypercapnic coma | 6 | 52.6(22.7-121.8) | 52·5 | 274·9 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Somnolence | 1342 | 11.8(11.2–12.5) | 10·8 | 11,755·4 | 1276 | 28.5(26.7–30.3) | 22·7 | 26,218·4 | 516 | 4.6(4.2-5.0) | 4·4 | 1378·1 | 33 | 6.1(4.3–8.6) | 5·8 | 131·9 | 498 | 5.0(4.6–5.5) | 4·8 | 1519·0 | |
Hyporesponsive to stimuli | 9 | 10.2(5.3–19.8) | 10·2 | 73·4 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Psychomotor skills impaired | 10 | 5.3(2.8–9.8) | 5·3 | 34·1 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Formication | 17 | 4.1(2.6–6.6) | 4·1 | 39·5 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | |
Sedation | 39 | 2.8(2.0-3.8) | 2·8 | 43·5 | 16 | 2.5(1.5–4.1) | 2·5 | 14·5 | – | – | – | – | – | – | – | – | – | – | – | – | |
Loss of consciousness | – |  | – | – | 76 | 2.3(1.8–2.9) | 2·3 | 55·2 | – | – | – | – | – | – | – | – | – | – | – | – | |
Altered state of consciousness | – | – | – | – | 16 | 2.8(1.6–4.4) | 2·7 | 16·7 | – | – | – | – | 3 | 5.0(1.6–15.7) | 5·0 | 9·7 | – | – | – | – | |
Depressed level of consciousness | – | – | – | – | – | – | – | – | – | – | – | – | 6 | 5.7(2.5–12.7) | 5·6 | 22·9 | – | – | – | – | |
Head discomfort | – | – | – | – | – | – | – | – | 30 | 2.6(1.8–3.7) | 2·6 | 29·0 | – | – | – | – | 36 | 3.5(2.5–4.9) | 3·5 | 64·0 | |
Coma | – | – | – | – | – | – | – | – | – | – | – | – | 6 | 4.5-(2.0–10.0) | 4·4 | 16·0 | – | – | – | – | |
Ageusia | – | – | – | – | – | – | – | – | – | – | – | – | 3 | 4.5(1.4–13.9) | 4·4 | 8·0 | – | – | – | – | |
Syncope | – | – | – | – | – | – | – | – | – | – | – | – | 12 | 4.5(2.5–7.9) | 4·4 | 31·8 | – | – | – | – | |
Speech disorder | – | – | – | – | – | – | – | – | – | – | – | – | 5 | 3.5(1.5–8.5) | 3·5 | 8·9 | – | – | – | – | |
Balance disorder | – | – | – | – | – | – | – | – | – | – | – | – | 7 | 2.9(1.3–6.1) | 2·9 | 8·5 | – | – | – | – | |
Seizures (incl subtypes) | Tonic clonic movements | 3 | 3.6(1.2–11.1) | 3·6 | 5·5 | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Febrile convulsion | – | – | – | – | 17 | 71.2(43.6-116.4) | 71·0 | 1104·3 | – | – | – | – | – | – | – | – | – | – | – | – | |
Epilepsy | – | – | – | – | – | – | – | – | – | – | – | – | 4 | 4.9(1.8–13.0) | 4·9 | 12·2 | – | – | – | – | |
Seizure | – | – | – | – | – | – | – | – | – | – | – | – | 11 | 2.6(1.4–4.6) | 2·5 | 10·1 | – | – | – | – | |
Clonic convulsion | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | – | 4 | 12.8(4.8–34.4) | 12·8 | 42·6 | |
Sleep disturbances (incl subtypes) | Sleep paralysis | – | – | – | – | 4 | 9.8(3.7–26.2) | 9·8 | 31·3 | – | – | – | – | – | – | – | – | – | – | – | – |
Hypersomnia | 58 | 3.2(2.5–4.2) | 3·2 | 87·4 | 68 | 8.4(6.6–10.7) | 8·3 | 437·0 | – | – | – | – | – | – | – | – | – | – | – | – | |
Sleep deficit | – | – | – | – | 3 | 4.6(1.5–14.3) | 4·6 | 8·4 | – | – | – | – | – | – | – | – | – | – | – | – | |