From: Post-marketing safety surveillance and re-evaluation of Xueshuantong injection
Systems/organs | Number of cases/incidence rate ‰ | Constituent ratio (%) | Manifestations (number of cases/frequency‰) |
---|---|---|---|
Skin and its appendages | 125/4.05 | 52.97 | erythra (61/1.98), pruritus (50/1.62), maculopapule (8/0.26), hyperhidrosis (4/0.13), urticaria (4/0.13) |
Systemic injury | 22/0.71 | 9.32 | fever (6/0.19), Shiver (6/0.19), edema (4/0.13), Chest pain (2/0.06), anaphylactoid reaction (1/0.03), periorbital edema (1/0.03), hot flush (1/0.03), acratia (1/0.03) |
Central and peripheral nervous system damage | 21/0.68 | 8.90 | headache (9/0.29), giddy (6/0.19), paresthesia (4/0.13), lower limb spasticity (1/0.03), tremor (1/0.03) |
Gastrointestinal system damage | 14/0.45 | 5.93 | sicchasia (4/0.13), vomit (2/0.06), hemorrhage of gastrointestinal tract (1/0.03), aggravation of gastrointestinal bleeding (1/0.03), dry lips (1/0.03), Stool discoloration (1/0.03), abdominal pain (1/0.03), discoloration of tongue (1/0.03), flatulence (1/0.03), toothache (1/0.03) |
Respiratory system damage | 14/0.45 | 5.93 | Chest tightness (10), dyspnea (2), laryngeal spasm (1/0.03), epistaxis (1/0.03) |
Extra cardiac vessel damage | 10/0.32 | 4.24 | flushing (9/0.29), phlebitis (1/0.03) |
Medication site damage | 10/0.32 | 4.24 | local numbness (4/0.13), injection site pain (4/0.13), injection site numbness (1/0.03), injection site pruritus (1/0.03) |
Urinary system damage | 7/0.23 | 2.97 | facial edema (6/0.19), hematuria (1/0.03) |
Heart rate and arrhythmia | 6/0.19 | 2.54 | palpitation (5/0.16), tachycardia (1/0.03) |
Nerve disorders | 4/0.13 | 1.69 | feel suffocated (3/0.10), insomnia (1/0.03) |
Visual impairment | 1/0.03 | 0.42 | abnormal tears (1/0.03) |
General cardiovascular system damage | 1/0.03 | 0.42 | Hypertension (1/0.03) |
latelets and bleeding, coagulopathy | 1/0.03 | 0.42 | Gingival bleeding (1/0.03) |
Total | 236 | 100.00 |