TABLE 2.
Signal strength of reports of donepezil plus memantine administration at the preferred term level in the FAERS database.
| PTs and categories | Case reports | ROR (95% CI) | PRR (95% CI) | chisq | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| Nervous system disorders | ||||||
| Dizziness | 182 | 2.82 (2.43, 3.26) | 2.77 (2.41, 3.18) | 208.02 | 1.47 (1.26) | 2.77 (2.45) |
| Somnolence | 165 | 6.36 (5.45, 7.42) | 6.24 (5.33, 7.3) | 727.26 | 2.64 (2.42) | 6.23 (5.48) |
| Tremor | 78 | 3.49 (2.79, 4.36) | 3.46 (2.79, 4.29) | 136.79 | 1.79 (1.47) | 3.46 (2.87) |
| Syncope | 60 | 4.48 (3.48, 5.78) | 4.46 (3.46, 5.75) | 161 | 2.15 (1.79) | 4.45 (3.6) |
| Lethargy | 59 | 7.59 (5.88, 9.81) | 7.54 (5.84, 9.73) | 334.64 | 2.91 (2.55) | 7.53 (6.08) |
| Loss of consciousness | 52 | 3.03 (2.31, 3.98) | 3.02 (2.3, 3.97) | 70.24 | 1.59 (1.2) | 3.02 (2.4) |
| Dyskinesia | 49 | 9.02 (6.81, 11.95) | 8.97 (6.82, 11.8) | 346.62 | 3.16 (2.76) | 8.96 (7.08) |
| Hypersomnia | 41 | 11.07 (8.14, 15.05) | 11.01 (8.05, 15.07) | 372.78 | 3.46 (3.02) | 11 (8.5) |
| Speech disorder | 37 | 5.24 (3.79, 7.24) | 5.22 (3.81, 7.14) | 126.13 | 2.38 (1.92) | 5.21 (3.98) |
| Depressed level of consciousness | 36 | 6.87 (4.95, 9.53) | 6.84 (4.9, 9.54) | 179.42 | 2.77 (2.31) | 6.83 (5.19) |
| Pleurothotonus | 36 | 290.8 (207.97,406.64) | 289.4 (207.39,403.84) | 9,867.91 | 8.11 (7.63) | 276.05 (208.53) |
| Myoclonus | 32 | 20 (14.12, 28.32) | 19.92 (14, 28.35) | 573.13 | 4.31 (3.82) | 19.85 (14.84) |
| Altered state of consciousness | 31 | 11.69 (8.21, 16.64) | 11.64 (8.18, 16.56) | 301.11 | 3.54 (3.04) | 11.62 (8.65) |
| Encephalopathy | 28 | 8.84 (6.1, 12.82) | 8.81 (6.07, 12.79) | 193.76 | 3.14 (2.61) | 8.8 (6.45) |
| Psychomotor hyperactivity | 28 | 11.92 (8.22, 17.28) | 11.88 (8.19, 17.24) | 278.43 | 3.57 (3.04) | 11.85 (8.69) |
| Dementia | 27 | 8.11 (5.56, 11.84) | 8.09 (5.57, 11.74) | 167.59 | 3.01 (2.48) | 8.08 (5.89) |
| Sedation | 26 | 8.31 (5.65, 12.22) | 8.29 (5.6, 12.27) | 166.45 | 3.05 (2.5) | 8.28 (6) |
| Dementia alzheimer’s type | 26 | 21.39 (14.55, 31.47) | 21.32 (14.41, 31.55) | 501.92 | 4.41 (3.86) | 21.25 (15.39) |
| Cognitive disorder | 21 | 3.49 (2.28, 5.36) | 3.49 (2.27, 5.37) | 37.23 | 1.8 (1.2) | 3.48 (2.43) |
| Tardive dyskinesia | 20 | 4.67 (3.01, 7.24) | 4.66 (3.03, 7.17) | 57.45 | 2.22 (1.6) | 4.66 (3.22) |
| Epilepsy | 19 | 5.02 (3.2, 7.87) | 5.01 (3.19, 7.86) | 60.91 | 2.32 (1.69) | 5 (3.43) |
| Mental impairment | 18 | 5.57 (3.51, 8.84) | 5.56 (3.47, 8.9) | 67.23 | 2.47 (1.82) | 5.55 (3.77) |
| Aphasia | 17 | 4.14 (2.57, 6.67) | 4.14 (2.59, 6.63) | 40.42 | 2.05 (1.38) | 4.13 (2.78) |
| Extrapyramidal disorder | 17 | 4.47 (2.78, 7.2) | 4.46 (2.79, 7.14) | 45.67 | 2.16 (1.49) | 4.46 (3) |
| Serotonin syndrome | 15 | 6.4 (3.86, 10.63) | 6.39 (3.84, 10.64) | 68.17 | 2.67 (1.97) | 6.39 (4.18) |
| Cerebral atrophy | 14 | 24.45 (14.46, 41.34) | 24.4 (14.37, 41.42) | 312.96 | 4.6 (3.87) | 24.31 (15.66) |
| Dystonia | 14 | 4.99 (2.95, 8.43) | 4.98 (2.93, 8.45) | 44.55 | 2.32 (1.58) | 4.98 (3.21) |
| Generalised tonic-clonic seizure | 13 | 6.68 (3.87, 11.51) | 6.67 (3.85, 11.55) | 62.59 | 2.74 (1.98) | 6.66 (4.22) |
| Parkinsonism | 7 | 5.81 (2.77, 12.21) | 5.81 (2.76, 12.24) | 27.86 | 2.54 (1.54) | 5.81 (3.12) |
| Facial spasm | 7 | 45.38 (21.56, 95.49) | 45.34 (21.53, 95.49) | 301.22 | 5.49 (4.49) | 45 (24.15) |
| Drooling | 6 | 6.95 (3.12, 15.49) | 6.95 (3.11, 15.52) | 30.53 | 2.8 (1.73) | 6.94 (3.55) |
| Non-24-h sleep-wake disorder | 6 | 385.14 (168.63,879.62) | 384.83 (168.95,876.56) | 2,157.78 | 8.5 (7.39) | 361.57 (181.16) |
| Partial seizures | 5 | 7.67 (3.19, 18.44) | 7.66 (3.17, 18.5) | 28.93 | 2.94 (1.78) | 7.65 (3.67) |
| Incoherent | 5 | 5.43 (2.26, 13.05) | 5.42 (2.24, 13.09) | 18.03 | 2.44 (1.28) | 5.42 (2.6) |
| Cerebral ischaemia | 5 | 6.57 (2.73, 15.79) | 6.56 (2.72, 15.85) | 23.55 | 2.71 (1.56) | 6.56 (3.15) |
| Lacunar infarction | 4 | 11.22 (4.21, 29.94) | 11.22 (4.21, 29.9) | 37.16 | 3.49 (2.22) | 11.2 (4.93) |
| Bradykinesia | 4 | 6.31 (2.37, 16.83) | 6.31 (2.37, 16.81) | 17.84 | 2.66 (1.39) | 6.3 (2.77) |
| Muscle contractions involuntary | 3 | 6.04 (1.94, 18.73) | 6.03 (1.93, 18.79) | 12.59 | 2.59 (1.18) | 6.03 (2.34) |
| Normal pressure hydrocephalus | 3 | 54.74 (17.56, 170.66) | 54.72 (17.56, 170.55) | 156.79 | 5.76 (4.34) | 54.23 (20.95) |
| Circadian rhythm sleep disorder | 3 | 28.55 (9.18, 88.79) | 28.54 (9.16, 88.95) | 79.35 | 4.83 (3.41) | 28.41 (10.99) |
| Psychiatric disorders | ||||||
| Confusional state | 298 | 14.3 (12.74, 16.06) | 13.77 (12.24, 15.49) | 3,530.93 | 3.78 (3.61) | 13.74 (12.47) |
| Agitation | 142 | 14.09 (11.93, 16.64) | 13.84 (11.83, 16.19) | 1,690.22 | 3.79 (3.55) | 13.81 (12.02) |
| Aggression | 88 | 12.62 (10.22, 15.57) | 12.48 (10.06, 15.48) | 928.31 | 3.64 (3.34) | 12.46 (10.45) |
| Hallucination | 60 | 6.34 (4.91, 8.17) | 6.29 (4.88, 8.12) | 267.13 | 2.65 (2.29) | 6.29 (5.08) |
| Abnormal behaviour | 50 | 8.56 (6.48, 11.3) | 8.51 (6.47, 11.2) | 331 | 3.09 (2.69) | 8.5 (6.73) |
| Hallucination, visual | 42 | 16.24 (11.99, 22) | 16.15 (12.04, 21.67) | 595.68 | 4.01 (3.58) | 16.11 (12.5) |
| Disorientation | 40 | 7.2 (5.28, 9.83) | 7.17 (5.24, 9.81) | 212.25 | 2.84 (2.4) | 7.16 (5.52) |
| Delirium | 38 | 8.71 (6.33, 11.99) | 8.67 (6.34, 11.86) | 257.75 | 3.11 (2.66) | 8.66 (6.63) |
| Restlessness | 34 | 6.86 (4.9, 9.61) | 6.84 (4.9, 9.54) | 169.3 | 2.77 (2.29) | 6.83 (5.15) |
| Irritability | 25 | 2.98 (2.01, 4.41) | 2.97 (2.01, 4.4) | 32.66 | 1.57 (1.01) | 2.97 (2.14) |
| Nightmare | 24 | 5.03 (3.37, 7.5) | 5.01 (3.39, 7.41) | 77.09 | 2.32 (1.76) | 5.01 (3.58) |
| Anger | 20 | 4.18 (2.7, 6.49) | 4.17 (2.71, 6.42) | 48.26 | 2.06 (1.44) | 4.17 (2.89) |
| Mania | 20 | 8.89 (5.73, 13.79) | 8.87 (5.76, 13.65) | 139.42 | 3.15 (2.53) | 8.85 (6.13) |
| Mental status changes | 17 | 4.49 (2.79, 7.23) | 4.48 (2.8, 7.17) | 45.95 | 2.16 (1.5) | 4.48 (3.01) |
| Hallucination, auditory | 17 | 8.13 (5.05, 13.09) | 8.12 (5.07, 13) | 105.95 | 3.02 (2.35) | 8.11 (5.44) |
| Eating disorder | 16 | 5.66 (3.46, 9.24) | 5.65 (3.46, 9.22) | 61.18 | 2.5 (1.81) | 5.64 (3.74) |
| Delusion | 15 | 7.44 (4.48, 12.35) | 7.43 (4.46, 12.37) | 83.36 | 2.89 (2.18) | 7.42 (4.86) |
| Abnormal dreams | 15 | 3.72 (2.24, 6.17) | 3.71 (2.23, 6.18) | 29.72 | 1.89 (1.18) | 3.71 (2.43) |
| Sopor | 14 | 7.42 (4.39, 12.53) | 7.4 (4.36, 12.56) | 77.46 | 2.89 (2.16) | 7.4 (4.77) |
| Paranoia | 13 | 5.44 (3.16, 9.38) | 5.43 (3.14, 9.4) | 46.99 | 2.44 (1.68) | 5.43 (3.44) |
| Personality change | 10 | 7.45 (4, 13.85) | 7.44 (3.97, 13.93) | 55.67 | 2.89 (2.04) | 7.43 (4.42) |
| Apathy | 9 | 4.69 (2.44, 9.02) | 4.69 (2.46, 8.96) | 26.08 | 2.23 (1.33) | 4.68 (2.71) |
| Euphoric mood | 9 | 6.24 (3.25, 12) | 6.24 (3.27, 11.91) | 39.53 | 2.64 (1.74) | 6.23 (3.6) |
| Flight of ideas | 8 | 98.7 (49.06, 198.56) | 98.59 (48.68, 199.65) | 760.26 | 6.6 (5.65) | 97.01 (54.05) |
| Behaviour disorder | 8 | 17.16 (8.57, 34.37) | 17.15 (8.64, 34.06) | 121.3 | 4.1 (3.15) | 17.1 (9.57) |
| Logorrhoea | 7 | 13.77 (6.56, 28.92) | 13.76 (6.53, 28.98) | 82.63 | 3.78 (2.78) | 13.73 (7.38) |
| Tension | 6 | 7 (3.14, 15.6) | 7 (3.13, 15.63) | 30.82 | 2.81 (1.74) | 6.99 (3.58) |
| Staring | 5 | 14.66 (6.09, 35.26) | 14.65 (6.06, 35.39) | 63.43 | 3.87 (2.71) | 14.61 (7.01) |
| Lack of spontaneous speech | 5 | 79.58 (32.92, 192.38) | 79.53 (32.92, 192.12) | 382.62 | 6.29 (5.13) | 78.5 (37.51) |
| Emotional poverty | 5 | 24.3 (10.09, 58.51) | 24.29 (10.05, 58.68) | 111.19 | 4.6 (3.44) | 24.19 (11.6) |
| Enuresis | 4 | 7.62 (2.86, 20.31) | 7.61 (2.86, 20.28) | 22.95 | 2.93 (1.66) | 7.6 (3.35) |
| Sleep talking | 4 | 17.71 (6.63, 47.27) | 17.7 (6.64, 47.16) | 62.84 | 4.14 (2.87) | 17.65 (7.76) |
| Listless | 4 | 8.95 (3.36, 23.87) | 8.95 (3.36, 23.85) | 28.19 | 3.16 (1.89) | 8.93 (3.93) |
| Catatonia | 4 | 6.12 (2.3, 16.32) | 6.12 (2.3, 16.31) | 17.12 | 2.61 (1.35) | 6.11 (2.69) |
| Abulia | 4 | 34.55 (12.93, 92.33) | 34.53 (12.96, 92) | 129.48 | 5.1 (3.83) | 34.34 (15.08) |
| Impulsive behaviour | 4 | 7.85 (2.94, 20.94) | 7.85 (2.95, 20.92) | 23.87 | 2.97 (1.7) | 7.84 (3.45) |
| Belligerence | 3 | 45.21 (14.51, 140.8) | 45.19 (14.5, 140.85) | 128.66 | 5.49 (4.07) | 44.86 (17.34) |
| Libido increased | 3 | 10.46 (3.37, 32.46) | 10.45 (3.35, 32.57) | 25.6 | 3.38 (1.97) | 10.44 (4.04) |
| Sexually inappropriate behaviour | 3 | 55.08 (17.67, 171.72) | 55.06 (17.67, 171.61) | 157.78 | 5.77 (4.35) | 54.57 (21.07) |
| Investigations | ||||||
| Heart rate decreased | 21 | 4.51 (2.94, 6.93) | 4.5 (2.92, 6.93) | 57.22 | 2.17 (1.57) | 4.5 (3.14) |
| Electrocardiogram qt prolonged | 18 | 3.91 (2.46, 6.21) | 3.9 (2.44, 6.24) | 38.87 | 1.96 (1.31) | 3.9 (2.65) |
| Blood urea increased | 17 | 6.87 (4.27, 11.06) | 6.86 (4.29, 10.98) | 85.01 | 2.78 (2.11) | 6.85 (4.6) |
| Respiratory rate increased | 17 | 14.44 (8.97, 23.26) | 14.41 (9, 23.07) | 211.74 | 3.85 (3.18) | 14.38 (9.65) |
| Electrocardiogram pr prolongation | 16 | 172.95 (105.16,284.45) | 172.58 (105.73,281.71) | 2,652.68 | 7.39 (6.69) | 167.76 (110.63) |
| Blood pressure systolic increased | 15 | 5.99 (3.61, 9.95) | 5.98 (3.59, 9.95) | 62.2 | 2.58 (1.87) | 5.98 (3.91) |
| Blood creatine phosphokinase increased | 14 | 3.34 (1.98, 5.64) | 3.33 (1.96, 5.65) | 22.89 | 1.74 (1.01) | 3.33 (2.15) |
| Haematocrit decreased | 12 | 4.13 (2.35, 7.28) | 4.13 (2.34, 7.29) | 28.44 | 2.04 (1.26) | 4.13 (2.57) |
| Blood albumin decreased | 10 | 9.12 (4.91, 16.97) | 9.11 (4.87, 17.06) | 72.13 | 3.19 (2.33) | 9.1 (5.41) |
| Blood sodium decreased | 9 | 3.65 (1.9, 7.01) | 3.64 (1.91, 6.95) | 17.24 | 1.86 (0.97) | 3.64 (2.11) |
| Electroencephalogram abnormal | 8 | 17.5 (8.74, 35.04) | 17.48 (8.8, 34.71) | 123.94 | 4.12 (3.18) | 17.43 (9.75) |
| Body temperature decreased | 6 | 4.36 (1.96, 9.71) | 4.36 (1.95, 9.74) | 15.5 | 2.12 (1.05) | 4.35 (2.23) |
| Lipase increased | 6 | 5.78 (2.6, 12.88) | 5.78 (2.59, 12.91) | 23.69 | 2.53 (1.46) | 5.77 (2.95) |
| Protein total decreased | 5 | 9.71 (4.04, 23.36) | 9.71 (4.02, 23.46) | 38.98 | 3.28 (2.12) | 9.69 (4.65) |
| Creatinine renal clearance decreased | 5 | 8.86 (3.68, 21.3) | 8.85 (3.66, 21.38) | 34.77 | 3.14 (1.99) | 8.84 (4.24) |
| Blood pressure diastolic decreased | 5 | 5.1 (2.12, 12.27) | 5.1 (2.11, 12.32) | 16.47 | 2.35 (1.19) | 5.1 (2.45) |
| Blood chloride increased | 4 | 17.8 (6.67, 47.51) | 17.79 (6.68, 47.4) | 63.21 | 4.15 (2.88) | 17.74 (7.8) |
| Blood sodium increased | 4 | 10.85 (4.07, 28.93) | 10.84 (4.07, 28.88) | 35.67 | 3.44 (2.17) | 10.82 (4.76) |
| Computerised tomogram abnormal | 3 | 9 (2.9, 27.94) | 9 (2.89, 28.05) | 21.29 | 3.17 (1.75) | 8.98 (3.48) |
| Blood magnesium increased | 3 | 24 (7.72, 74.59) | 23.99 (7.7, 74.77) | 65.82 | 4.58 (3.16) | 23.9 (9.25) |
| Fibrin d dimer increased | 3 | 6.63 (2.14, 20.57) | 6.63 (2.13, 20.66) | 14.32 | 2.73 (1.31) | 6.62 (2.57) |
| Blood phosphorus increased | 3 | 8.8 (2.84, 27.32) | 8.8 (2.82, 27.43) | 20.7 | 3.14 (1.72) | 8.79 (3.41) |
| Brain natriuretic peptide increased | 3 | 7.51 (2.42, 23.31) | 7.51 (2.41, 23.41) | 16.91 | 2.91 (1.49) | 7.5 (2.91) |
| Lymphocyte percentage decreased | 3 | 15.24 (4.91,47.32) | 15.23 (4.89, 47.47) | 39.78 | 3.93 (2.51) | 15.19 (5.89) |
| Blood chloride decreased | 3 | 7.87 (2.54, 24.42) | 7.87 (2.53, 24.53) | 17.96 | 2.97 (1.56) | 7.86 (3.05) |
| Cardiac disorders | ||||||
| Bradycardia | 81 | 11.35 (9.12, 14.13) | 11.24 (9.06, 13.94) | 754.92 | 3.49 (3.17) | 11.22 (9.34) |
| Sinus bradycardia | 22 | 16.87 (11.09, 25.65) | 16.82 (11.14, 25.39) | 326.52 | 4.07 (3.48) | 16.78 (11.81) |
| Atrioventricular block first degree | 14 | 22.1 (13.07, 37.36) | 22.06 (13, 37.45) | 280.42 | 4.46 (3.73) | 21.98 (14.16) |
| Atrioventricular block complete | 9 | 10.22 (5.31, 19.66) | 10.21 (5.35, 19.5) | 74.62 | 3.35 (2.45) | 10.19 (5.89) |
| Ventricular fibrillation | 8 | 5.26 (2.63, 10.53) | 5.26 (2.65, 10.45) | 27.57 | 2.39 (1.45) | 5.26 (2.94) |
| Ventricular extrasystoles | 7 | 4.79 (2.28, 10.05) | 4.78 (2.27, 10.07) | 20.93 | 2.26 (1.26) | 4.78 (2.57) |
| Cardiac failure acute | 6 | 7.47 (3.35, 16.64) | 7.46 (3.34, 16.66) | 33.54 | 2.9 (1.83) | 7.45 (3.81) |
| Bundle branch block left | 5 | 8.31 (3.46, 19.99) | 8.31 (3.44, 20.07) | 32.1 | 3.05 (1.9) | 8.3 (3.98) |
| Supraventricular extrasystoles | 4 | 8.3 (3.11, 22.14) | 8.3 (3.12, 22.11) | 25.64 | 3.05 (1.79) | 8.29 (3.65) |
| Sinoatrial block | 3 | 34.29 (11.02, 106.7) | 34.28 (11, 106.84) | 96.38 | 5.09 (3.67) | 34.09 (13.19) |
| Injury, poisoning and procedural complications | ||||||
| Fall | 136 | 3.14 (2.65, 3.72) | 3.1 (2.65, 3.63) | 195.05 | 1.63(1.39) | 3.1 (2.69) |
| Accidental overdose | 23 | 5.11 (3.39, 7.7) | 5.1 (3.38, 7.7) | 75.73 | 2.35 (1.77) | 5.09 (3.62) |
| Accidental exposure to product by child | 16 | 17.69 (10.82, 28.91) | 17.65 (10.81, 28.81) | 250.66 | 4.14 (3.45) | 17.6 (11.67) |
| Product administration interrupted | 8 | 13.26 (6.62, 26.54) | 13.24 (6.67, 26.29) | 90.36 | 3.72 (2.78) | 13.22 (7.39) |
| Skin laceration | 7 | 5.7 (2.72, 11.97) | 5.7 (2.71, 12) | 27.09 | 2.51 (1.51) | 5.69 (3.06) |
| Femoral neck fracture | 5 | 7.34 (3.05, 17.65) | 7.34 (3.04, 17.73) | 27.33 | 2.87 (1.72) | 7.33 (3.52) |
| Skin abrasion | 4 | 7.19 (2.7, 19.17) | 7.19 (2.7, 19.16) | 21.28 | 2.84 (1.58) | 7.18 (3.16) |
| Wrong patient received product | 3 | 11.48 (3.7, 35.65) | 11.48 (3.68, 35.78) | 28.64 | 3.52 (2.1) | 11.46 (4.44) |
| Jaw fracture | 3 | 9.8 (3.16, 30.42) | 9.79 (3.14, 30.51) | 23.65 | 3.29 (1.87) | 9.78 (3.79) |
| Metabolism and nutrition disorders | ||||||
| Hypernatraemia | 16 | 24.97 (15.27, 40.82) | 24.92 (15.27, 40.68) | 365.84 | 4.63 (3.95) | 24.82 (16.45) |
| Hypophagia | 12 | 3.75 (2.13, 6.6) | 3.74 (2.12, 6.6) | 24.09 | 1.9 (1.12) | 3.74 (2.33) |
| Failure to thrive | 7 | 9.45 (4.5, 19.83) | 9.44 (4.48, 19.88) | 52.73 | 3.24 (2.24) | 9.42 (5.07) |
| Hypovolaemia | 6 | 7.54 (3.39, 16.8) | 7.54 (3.38, 16.84) | 33.97 | 2.91 (1.84) | 7.53 (3.85) |
| Hyperphagia | 6 | 12.19 (5.47, 27.17) | 12.18 (5.45, 27.2) | 61.46 | 3.6 (2.53) | 12.16 (6.22) |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 5 | 41.86 (17.36, 100.9) | 41.83 (17.32, 101.05) | 197.88 | 5.38 (4.22) | 41.54 (19.9) |
| Polydipsia | 5 | 9.05 (3.76, 21.75) | 9.04 (3.74, 21.84) | 35.7 | 3.17 (2.02) | 9.03 (4.33) |
| Diet refusal | 4 | 35 (13.1, 93.56) | 34.98 (13.13, 93.2) | 131.28 | 5.12 (3.85) | 34.79 (15.28) |
| General disorders and administration site conditions | ||||||
| Drug interaction | 62 | 2.95 (2.3, 3.79) | 2.94 (2.28, 3.79) | 79.38 | 1.55 (1.2) | 2.94 (2.38) |
| Crying | 16 | 3.07 (1.88, 5.02) | 3.07 (1.88, 5.01) | 22.31 | 1.62 (0.93) | 3.07 (2.03) |
| Hypothermia | 15 | 11.06 (6.66, 18.37) | 11.04 (6.63, 18.38) | 136.8 | 3.46 (2.75) | 11.03 (7.21) |
| Screaming | 8 | 9.31 (4.65, 18.64) | 9.3 (4.68, 18.47) | 59.2 | 3.22 (2.27) | 9.29 (5.2) |
| Foaming at mouth | 7 | 25.44 (12.1, 53.46) | 25.41 (12.07, 53.51) | 163.48 | 4.66 (3.66) | 25.31 (13.6) |
| Sluggishness | 6 | 4.44 (1.99, 9.88) | 4.43 (1.98, 9.89) | 15.95 | 2.15 (1.08) | 4.43 (2.27) |
| Energy increased | 4 | 4.84 (1.81, 12.89) | 4.83 (1.81, 12.87) | 12.15 | 2.27 (1.01) | 4.83 (2.13) |
| Infections and infestations | ||||||
| Urinary tract infection | 58 | 2.69 (2.08, 3.48) | 2.68 (2.08, 3.46) | 61.14 | 1.42 (1.05) | 2.68 (2.16) |
| Pneumonia aspiration | 17 | 5.24 (3.25, 8.43) | 5.23 (3.27, 8.37) | 58.08 | 2.38 (1.72) | 5.22 (3.51) |
| Gastrointestinal infection | 11 | 9.78 (5.41, 17.67) | 9.76 (5.42, 17.57) | 86.4 | 3.29 (2.47) | 9.75 (5.94) |
| Urosepsis | 6 | 5 (2.25, 11.14) | 5 (2.24, 11.17) | 19.18 | 2.32 (1.25) | 5 (2.56) |
| Sialoadenitis | 3 | 17.5 (5.63, 54.36) | 17.49 (5.61, 54.51) | 46.51 | 4.12 (2.71) | 17.44 (6.76) |
| Renal and urinary disorders | ||||||
| Urinary incontinence | 43 | 10.81 (8.01, 14.6) | 10.76 (8.02, 14.44) | 380.06 | 3.42 (3) | 10.74 (8.36) |
| Pollakiuria | 22 | 4.02 (2.65, 6.11) | 4.01 (2.66, 6.05) | 49.8 | 2 (1.41) | 4.01 (2.83) |
| Hydronephrosis | 6 | 6.07 (2.73, 13.53) | 6.07 (2.72, 13.56) | 25.39 | 2.6 (1.53) | 6.06 (3.1) |
| Ketonuria | 5 | 44.88 (18.61, 108.21) | 44.85 (18.57, 108.35) | 212.76 | 5.48 (4.32) | 44.52 (21.32) |
| Gastrointestinal disorders | ||||||
| Constipation | 67 | 2.53 (1.99, 3.21) | 2.51 (1.98, 3.18) | 61.23 | 1.33 (0.98) | 2.51 (2.05) |
| Salivary hypersecretion | 13 | 10.06 (5.83, 17.34) | 10.04 (5.8, 17.38) | 105.68 | 3.33 (2.57) | 10.03 (6.36) |
| Eructation | 12 | 5.6 (3.18, 9.86) | 5.59 (3.17, 9.87) | 45.19 | 2.48 (1.7) | 5.58 (3.48) |
| Faecaloma | 6 | 8.82 (3.96, 19.64) | 8.81 (3.94, 19.68) | 41.49 | 3.14 (2.07) | 8.8 (4.5) |
| Vascular disorders | ||||||
| Circulatory collapse | 13 | 5.38 (3.12, 9.27) | 5.37 (3.1, 9.3) | 46.24 | 2.42 (1.67) | 5.37 (3.4) |
| Hypertensive crisis | 6 | 3.97 (1.78, 8.84) | 3.97 (1.78, 8.87) | 13.31 | 1.99 (0.92) | 3.97 (2.03) |
| Thrombophlebitis | 3 | 5.94 (1.91, 18.44) | 5.94 (1.91, 18.51) | 12.31 | 2.57 (1.15) | 5.93 (2.3) |
| Skin and subcutaneous tissue disorders | ||||||
| Skin oedema | 9 | 64.99 (33.68, 125.4) | 64.91 (33.99, 123.94) | 560.27 | 6.01 (5.1) | 64.23 (37.06) |
| Yellow skin | 6 | 9.38 (4.21, 20.89) | 9.37 (4.2, 20.93) | 44.8 | 3.23 (2.16) | 9.36 (4.79) |
| Decubitus ulcer | 5 | 4.46 (1.85, 10.71) | 4.45 (1.84, 10.75) | 13.38 | 2.15 (1) | 4.45 (2.14) |
| Musculoskeletal and connective tissue disorders | ||||||
| Rhabdomyolysis | 25 | 4.53 (3.06, 6.71) | 4.52 (3.05, 6.69) | 68.44 | 2.17 (1.62) | 4.51 (3.25) |
| Posture abnormal | 4 | 9.05 (3.39, 24.13) | 9.04 (3.39, 24.09) | 28.57 | 3.17 (1.91) | 9.03 (3.97) |
| Torticollis | 3 | 10.59 (3.41, 32.88) | 10.59 (3.4, 33.01) | 26 | 3.4 (1.99) | 10.57 (4.1) |
| Eye disorders | ||||||
| Miosis | 10 | 10.25 (5.51, 19.06) | 10.23 (5.46, 19.15) | 83.19 | 3.35 (2.5) | 10.22 (6.08) |
| Eye movement disorder | 6 | 6.57 (2.95, 14.63) | 6.56 (2.94, 14.65) | 28.26 | 2.71 (1.64) | 6.56 (3.35) |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Hiccups | 11 | 10.59 (5.86, 19.14) | 10.58 (5.88, 19.05) | 95.22 | 3.4 (2.58) | 10.56 (6.43) |
| Reproductive system and breast disorders | ||||||
| Prostatomegaly | 5 | 9.68 (4.02, 23.28) | 9.67 (4, 23.36) | 38.83 | 3.27 (2.12) | 9.66 (4.64) |
| Hepatobiliary disorders | ||||||
| Drug-induced liver injury | 13 | 4.12 (2.39, 7.1) | 4.11 (2.37, 7.12) | 30.65 | 2.04 (1.28) | 4.11 (2.61) |
| Endocrine disorders | ||||||
| Inappropriate antidiuretic hormone secretion | 17 | 13.13 (8.15, 21.14) | 13.1 (8.18, 20.97) | 189.58 | 3.71 (3.04) | 13.07 (8.77) |
Abbreviations: ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; chisq, chi-squared; IC, information component; EBGM, empirical Bayesian geometric mean; IC025, the lower limit of 95% CI, of the IC; EBGM05, the lower limit of 95% CI, of EBGM; PTs: preferred terms.