K-Cab Adverse Reactions

A total of 5 clinical studies were conducted with erosive gastroesophageal reflux disease and non-erosive gastroesophageal reflux disease and gastric ulcer patients. 360 patients were treated with tegoprazan 50 mg. Adverse events and adverse drug reactions (marked with *) reported during the clinical trials are as following.
Common adverse events reported (≥1%) in tegoprazan 50 mg treatment group are presented in Table 1 (See Table 1).

Click on icon to see table/diagram/image

Less common adverse events reported in <1% patients after administration of K-CAB 50 mg from clinical studies are listed below by body system:
Gastrointestinal Disorders: Abdominal pain upper*, abdominal discomfort*, constipation*, abdominal pain*, abdominal distension*, vomiting, eructation, abdominal pain lower, gastric ulcer*, anal haemorrhage, erosive duodenitis*, flatulence, gastric polyps*, gastroesophageal reflux disease, intestinal metaplasia, haematemesis, hemorrhoids, melaena*.
Infections and Infestations: Folliculitis*, gastroenteritis bacterial, latent tuberculosis.
Laboratory Investigations: Alanine aminotransferase increased*, aspartate aminotransferase increased, gamma-glutamyltransferase increased*, blood bilirubin increased, blood creatine phosphokinase increased*, blood urine present, red blood cells urine positive, blood gastrin increased*, blood triglycerides increased*.
General Disorders and Administration Site Conditions: Fatigue*.
Injury, Poisoning and Procedural Complications: Ligament sprain, concussion, excoriation, foot fracture, joint injury, muscle strain.
Musculoskeletal and Connective Tissue Disorders: Myalgia, arthralgia, tendonitis.
Nervous System Disorders: Headache*, dizziness.
Skin and Subcutaneous Tissue Disorders: Angioedema, dermatitis, seborrhoeic dermatitis*.
Respiratory, Thoracic and Mediastinal Disorders: Cough, oropharyngeal pain, throat irritation, nasopharyngitis*.
Reproductive System and Breast Disorders: Vaginal discharge, vulvovaginal pruritus, breast calcifications*, adenomyosis , ovarian cyst.
Hepatobiliary Disorders: Bile duct stone, hepatic cyst.
Renal and Urinary Disorders: Hypertonic bladder, nocturia, renal cyst.
Neoplasms Benign, Malignant and Unspecified: Breast cancer, gastrointestinal tract adenoma*, adenocarcinoma gastric, uterine leiomyoma.
Cardiac Disorders: Ventricular extrasystoles*.
Blood and Lymphatic System Disorders: Lymphadenitis*, anaemia*.
Psychiatric Disorders: Insomnia.
Surgical and Medical Procedures: Dental implantation.
Ear and Labyrinth Disorders: Ear pain*.
Metabolism and Nutrition Disorders: Diabetes mellitus.
Vascular Disorder: Hypertension.
Endocrine Disorders: Thyroid cyst*.
A clinical study was conducted in patients with peptic ulcer and/or chronic atrophic gastritis who were positive for H. pylori. 172 patients were treated with tegoprazan 50 mg, in combination with amoxicillin 1 g and clarithromycin 500 mg. Adverse events and adverse drug reactions (marked with *) reported during the clinical trial is as following: Common adverse events reported (≥1%) in tegoprazan 50 mg in combination with amoxicillin 1 g and clarithromycin 500 mg treatment group are presented in Table 2 (See Table 2).

Click on icon to see table/diagram/image

Less common adverse events reported in <1% patients after administration of K-CAB 50 mg in combination with amoxicillin 1 g and clarithromycin 500 mg from clinical study is listed below by body system:
Gastrointestinal Disorders: Vomiting, anal incontinence*.
Infections and Infestations: Folliculitis*, tonsillitis*.
Skin and Subcutaneous Tissue Disorders: Rash*, drug eruption*, toxic skin eruption*.
Cardiac Disorders: Palpitation*.
Laboratory Investigations: AST increased, LDH increased*.
Nervous System Disorders: Migraine*.
Respiratory, Thoracic and Mediastinal Disorders: Oropharyngeal pain, dysphonia.
Vascular Disorders: Hot flush*, flushing*.