Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Approximately 6000 patients received cefditoren at either 200 mg or 400 mg twice daily for up to 14 days in clinical trials. About 24% of patients reported at least one adverse reaction. Treatment discontinuation as a consequence of adverse reactions occurred in 2.6% of the patients.
The most commonly occurring adverse reactions were gastrointestinal events. In most studies, diarrhoea occurred in more than 10% of all patients and was more common with 400 mg than with 200 mg twice daily. The observed adverse reactions, reported either during clinical trials or post-marketing experience, are described below:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


Very       Common                                                               Not known common       Adverse         Uncommon                 Rare Adverse                 (cannot be System Organ
Adverse      Reactions    Adverse Reactions             Reactions               estimated from Class
Reactions     (≥1/100,    (≥1/1,000, <1/100)       (≥1/10,000, <1/1,000)         the available (≥1/10)       <1/10)                                                                 data) Prolonged coagulation time, increased AST,
increased alkaline phosphatase,
Leukopenia,                                        Serum carnitine
Investigations                                                               albuminuria, increased ALT                                          decreased thromboplastin time decrease, increased
LDH, and increased creatinine
Atrial fibrillation, heart failure, syncope,
Cardiac disorders tachycardia, ventricular extrasystole
Eosinophilia,
Blood and the                                                                 neutropenia Thrombocytosis,
lymphatic system                                                          trombocytopenia,          Agranulocytosis leukopenia disorders                                                               haemolytic anaemia, lymphadenopathy
Nervousness,
Amnesia,
dizziness,
Nervous system                                                           discoordination, Headache         insomnia,
disorders                                                             hypertonia, meningitis, somnolence, sleep tremor disorders
Amblyopia, eye
Eye disorders                                                           disorder, eye pain, blepharitis
Ear and labyrinth
Tinnitus disorders
Respiratory,                                                                                          Eosinophilic thoracic and                                      Pharyngitis,                                        pneumonia, Asthma mediastinal                                     rhinitis, sinusitis                                    interstitial disorders                                                                                             pneumonia Stomatitis,
Constipation,             mouth ulcers,
Nausea,          flatulence,         haemorrhagic colitis,
Gastrointestinal                 abdominal      vomiting, oral           ulcerative colitis, Diarrhoea disorders                          pain,          candidiasis,            gastrointestinal dyspepsia      eructation, dry       haemorrhage, glossitis,
mouth, dysgeusia         hiccup, discoloured tongue
Dysuria, pain in the renal cavity, nephritis,
Renal and urinary nycturia, polyuria,        Acute renal failure disorders incontinence,
albuminuria
Stevens Johnson
Acne, alopecia, eczema,
syndrome,
Skin and                                                          exfoliative dermatitis, Rash, pruritus,                                       erythema subcutaneous                                                            herpes simplex, urticaria                                       multiforme, toxic tissue disorders                                                         photosensitivity epidermal reaction necrolysis
Musculoskeletal,
connective tissue                                                             Myalgia disorders

Very      Common                                                          Not known common      Adverse          Uncommon             Rare Adverse               (cannot be System Organ
Adverse     Reactions     Adverse Reactions         Reactions             estimated from Class
Reactions    (≥1/100,     (≥1/1,000, <1/100)   (≥1/10,000, <1/1,000)       the available (≥1/10)      <1/10)                                                            data) Dehydration,
Metabolism and                                                          hyperglycemia, Anorexia nutrition disorders                                                       hypokalemia, hypoproteinemia
Urinary tract infection,
Infections and                   Vaginal
Fungal infection     Clostridium difficile infestations                   candidiasis diarrhoea
Vascular
Postural hypotension disorders
General disorders and                                       Fever, asthenia,
Body odour, chills administration site                              pain, sweating conditions
Anaphylactic
Immune system                                                                                    shock, serum disorders                                                                                    sickness disease 
Hepato-biliary                                  Hepatic function                                Liver injury, Bilirubinemia disorders                                       abnormal                                      Hepatitis Reproductive                                                        Mastalgia, menstrual Vaginitis,
systems and                                                       disorders, metrorrhagia, leukorrhea breast disorders                                                      erectile dysfunction Dementia,
depersonalisation,
emotional weakness,
Psychiatric euphoria,
disorders hallucinations, thinking disorders, increased libido


The following adverse reactions could appear since they have been observed with other cephalosporins: cholestasis and aplastic anaemia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il