Adverse reactions : תופעות לוואי

4.8     Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions.
ADRs derived from clinical studies and post-marketing surveillance with ciprofloxacin (oral, intravenous and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.

System organ      Common             Uncommon            Rare ≥1/10,000 to      Very rare             Frequency not class             ≥1/100 to          > 1/1,000 to        <1/1,000               <1/10,000             known (cannot <1/10              <1/100                                                           be estimated from the available data)
Infections and                       Mycotic             Antibiotic infestations                         superinfections     associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Blood and the                        Eosinophilia        Leukopenia             Haemolytic lymphatic                                                Anaemia,               anaemia, system                                                   Neutropenia,           Agranulocytosis, disorders                          Leukocytosis,      Pancytopenia
Thrombocytopenia, (life-
Thrombocytemia     threatening),
Bone marrow depression (life- threatening)
Immune system                      Allergic reaction, Anaphylactic disorders                          Allergic oedema /  reaction,;
angioedema         Anaphylactic shock (life- threatening),
(see section 4.4)
Serum sickness- like reaction
Endocrine                                                                  Syndrome of disorders                                                                  inappropriate secretion of antidiuretic hormone
(SIADH)
Metabolism       Anorexia          Hyperglycaemia                          Hypoglycaemic and nutrition    Decreased         Hypoglycaemia                           coma (see disorders        appetite          (see section 4.4)                       section 4.4) 
Psychiatric      Psychomotor       Confusion and         Psychotic         Mania, incl.
disorders (*)    hyperactivity /   disorientation,       reactions         hypomania agitation         Anxiety reaction,     (potentially
Abnormal dreams,      culminating in
Depression,           suicidal
(potentially          ideations/ culminating in        thoughts or suicidal              suicide ideations/thoughts    attempts or suicide attempts   and completed and completed         suicide) (see suicide) (see         section 4.4) section 4.4)
Hallucinations



Nervous system   Headache,         Par- and              Migraine,         Peripheral disorders (*)    Dizziness,        Dysaesthesia,         Disturbed         neuropathy Sleep disorder,   Hypoaesthesia,        coordination,     and
Taste disorder    Tremor, Seizures      Gait              polyneuropathy (including status     disturbance,      (see section epilepticus see       Olfactory nerve   4.4) section 4.4)          disorder
Vertigo,              Intracranial hypertension and pseudotumor cerebri

Eye disorders                      Visual disturbances   Visual colour (*)                                               (e.g. diplopia)        distortions 
Ear and                                           Tinnitus,
labyrinth                                         Hearing loss / disorders(*)                                      hearing impaired
Cardiac                                           Tachycardia                                 Ventricular disorders (**)                                                                                arrhythmia, torsades de pointes
(reported predominantly in patients with risk factors for
QT prolongation),
ECG QT prolonged (see section 4.4 and
4.9).
Vascular                                          Vasodilation,          Vasculitis disorders (**)                                    Hypotension,
Syncope
Respiratory,                                      Dyspnoea thoracic and                                      (including mediastinal                                       asthmatic disorders                                         condition)
Gastrointestinal   Nausea,     Vomiting,          Antibiotic-            Pancreatitis disorders          Diarrhoea   Gastrointestinal   associated colitis and abdominal      (very rarely with pain,              possible fatal
Dyspepsia,         outcome) (see
Flatulence,        section 4.4)
Hepato-biliary                 Increase in        Hepatic                Liver necrosis disorders                      transaminases,     impairment,            (very rarely Increased          Cholestatic icterus,   progressing to bilirubin          Hepatitis              life-threatening hepatic failure)
(see section 4.4)
Skin and                       Rash,              Photosensitivity       Petechiae,           Acute subcutaneous                   Pruritus,          reactions (see         Erythema             Generalised tissue disorders               Urticaria          section 4.4)           multiforme,          Exanthematous Erythema             Pustulosis nodosum,             (AGEP)
Stevens-             Drug Reaction
Johnson              with syndrome             Eosinophilia
(potentially life-   and Systemic threatening),        Symptoms
Toxic epidermal      (DRESS) necrolysis
(potentially life- threatening
Musculoskeletal                Musculoskeletal    Myalgia                Muscular and connective                 pain (e.g.         Arthritis,             weakness, tissue disorders               extremity pain,    Increased muscle       Tendinitis (*)                            back pain, chest   tone and cramping      Tendon pain),                                    ruptures
Arthralgia                               (predominantly
Achilles tendon)
(see section
4.4),
Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Renal and                            Renal              Renal failure, urinary                              impairment,        Haematuria,
disorders                                               Crystalluria (see section 4.4),
Tubulointerstitial nephritis
General            Injection and   Asthenia,            Oedema,
disorders and      infusion site   Fever                Sweating administration     reactions (only                      (hyperhidrosis) site               intravenous conditions(*)      administration)
Investigations                     Increased blood      Prothrombin level                         International alkaline             abnormal,                                 normalised phosphatase          increased amylase                         ratio increased (in patients treated with
Vitamin K antagonists)

*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 4.4).
**Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment: 
Common                          Vomiting, Transient increase in transaminases, Rash Uncommon                        Thrombocytopenia, Thrombocytaemia, Confusion and disorientation, Hallucinations, Par- and dysaesthesia,
Seizures, Vertigo, Visual disturbances, Hearing loss,
Tachycardia, Vasodilatation, Hypotension, Transient hepatic impairment, Cholestatic icterus, Renal failure, Oedema
Rare                            Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders,
Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis,
Petechiae, Tendon rupture

Paediatric population
The incidence of arthropathy (arthralgia, arthritis) mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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/