Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.
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                             Very Rare           Frequency Class            ≥ 1/100 to ≥ 1/1,000 to < ≥ 1/10,000 to <        < 1/10,000          not known < 1/10     1/100          1/1,000                                    (cannot be estimated from the available data)
Infections and              Mycotic
Infestations                super- infections
Blood and                   Eosinophilia   Leukopenia        Haemolytic anaemia Lymphatic                                  Anaemia           Agranulocytosis System                                     Neutropenia       Pancytopenia (life- Disorders                                  Leukocytosis      threatening) Thrombocytopenia Bone marrow
Thrombocythaemia depression (life- threatening)
Immune System                              Allergic reaction Anaphylactic Disorders                                  Allergic oedema / reaction angiooedema       Anaphylactic shock
(life-threatening)
(see section 4.4)
Serum sickness-like reaction
Endocrine                                                                             Syndrome of disorders                                                                             inappropriate secretion of antidiuretic hormone
(SIADH)
Metabolism and              Decreased       Hyperglycaemia
Nutrition                   appetite        Hypoglycaemia
Disorders                                   Hypoglycaemic coma
(see section 4.4)
Psychiatric                 Psychomotor Confusion and             Psychotic reactions Mania, incl.
Disorders*                  hyperactivity / disorientation        (potentially        hypomania agitation       Anxiety reaction      culminating in
Abnormal dreams       suicidal ideations/
Depression            thoughts or suicide
(potentially          attempts and culminating in        completed suicide) suicidal              (see section 4.4) ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)
Hallucinations
Nervous System              Headache        Par- and              Migraine            Peripheral Disorders*                  Dizziness       Dysaesthesia          Disturbed           neuropathy Sleep           Hypoaesthesia         coordination        and disorders       Tremor                Gait disturbance    polyneuropath Taste           Seizures (including   Olfactory nerve     y (see section disorders       status epilepticus    disorders           4.4) see section 4.4)
Vertigo
System Organ      Common Uncommon Rare                         Very Rare           Frequency Class             ≥ 1/100 to ≥ 1/1,000 to < ≥ 1/10,000 to <    < 1/10,000          not known < 1/10     1/100          1/1,000                                (cannot be estimated from the available data)
Intracranial hypertension and pseudotumor cerebri
*
Eye Disorders                             Visual              Visual colour disturbances (e.g. distortions diplopia)
Ear and                                   Tinnitus
Labyrinth                                 Hearing loss /
Disorders*                                Hearing impaired
Cardiac                                   Tachycardia                               Ventricular Disorders**                                                                         arrhythmia and torsades de pointes
(reported predominantly in patients with risk factors for QT prolongation),
ECG QT prolonged
(see sections
4.4 and 4.9)
Vascular                                  Vasodilatation      Vasculitis Disorders**                               Hypotension
Syncope
Respiratory,                              Dyspnoea
Thoracic and                              (including
Mediastinal                               asthmatic
Disorders                                 condition)
Gastrointestinal Nausea    Vomiting       Antibiotic          Pancreatitis Disorders        Diarrhoea Gastrointestin associated colitis al and         (very rarely with abdominal      possible fatal pains          outcome) (see
Dyspepsia      section 4.4)
Flatulence
Hepatobiliary              Increase in    Hepatic             Liver necrosis (very Disorders                  transaminase impairment            rarely progressing to s              Cholestatic icterus life-threatening
Increased      Hepatitis           hepatic failure) (see bilirubin                          section 4.4)
Skin and                   Rash           Photosensitivity    Petechiae             Acute Subcutaneous               Pruritus       reactions (see      Erythema              generalised Tissue                     Urticaria      section 4.4)        multiforme            exanthematou Disorders                                                     Erythema nodosum s pustulosis Stevens-Johnson       (AGEP) syndrome              Drug Reaction with
System Organ       Common Uncommon Rare                            Very Rare            Frequency Class              ≥ 1/100 to ≥ 1/1,000 to < ≥ 1/10,000 to <       < 1/10,000           not known < 1/10     1/100          1/1,000                                    (cannot be estimated from the available data)
(potentially life-        Eosinophilia threatening)              and Systemic
Toxic epidermal           Symptoms necrolysis                (DRESS)
(potentially life- threatening)
Musculo-                      Musculo-      Myalgia           Muscular weakness skeletal and                  skeletal pain Arthritis         Exacerbation of Connective                    (e.g.         Increased muscle symptoms of Tissue                        extremity     tone and cramping myasthenia gravis Disorders*                    pain, back    Tendinitis        (see section 4.4) pain, chest   Tendon rupture pain)         (predominantly
Arthralgia    Achilles tendon)
(see section 4.4)

Renal and                     Renal           Renal failure
Urinary                       impairment      Haematuria
Disorders                                     Crystalluria (see section 4.4)
Tubulointerstitial nephritis
General                       Asthenia        Oedema
Disorders and                 Fever           Sweating
Administration                                (hyperhidrosis)
Site Conditions*
Investigations                Increase in    Increased amylase                          International blood alkaline                                            normalised phosphatase                                               ratio increased (in patients treated with
Vitamin K antagonists)

* 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, fatigue, psychiatric symptoms, memory impairment, 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). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).
** 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).

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/