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/                   Common         Uncommon          Rare                        Very rare             Frequency organ class               > 1/100 to     > 1/1,000 to      > 1/10,000 to               < 1/10,000            unknown < 1/10         < 1/100           < 1/1,000                                         (cannot be estimated from the available data)
Infections and                           Mycotic           Antibiotic-associated infestations                             superinfections   colitis (very rarely with possible fatal outcome)
(see section 4.4)

Blood and                                Eosinophilia      Leukopoenia                 Haemolytic lymphatic system                                           Anaemia                     anaemia disorders                                                  Neutropoenia                Agranulocytosis Leukocytosis                Pancytopenia
Thrombocytopenia            (life-threatening)
Thrombocytemia              Bone marrow depression
(life-threatening)

Immune                                                     Allergic reaction           Anaphylactic system                                                     Allergic oedema /           reaction disorders                                                  angiooedema                 Anaphylactic shock (life-threatening)
(see section 4.4)
Serum sickness-like reaction


System/                   Common         Uncommon                    Rare                       Very rare                  Frequency organ class               > 1/100 to     > 1/1,000 to                > 1/10,000 to              < 1/10,000                 unknown < 1/10         < 1/100                     < 1/1,000                                             (cannot be estimated from the available data)
Endocrine disorders                                                                                                        Syndrome of inappropriate secretion of antidiuretic hormone
(SIADH)
Metabolism and                           Anorexia                    Hyperglycemia                                         Hypoglycaemic coma Nutrition                                Decreased appetite          Hypoglycaemia (see                                    (see section 4.4) disorders                                                            section 4.4) Psychic                                  Psychomotor                 Confusion                  Psychotic reactions        Mania, incl. hypomania Disorders*                               hyperactivity / agitation   and disorientation         (potentially culminating Anxiety reaction           in suicidal
Abnormal dreams            ideations/thoughts or
Depression                 suicide attempts and
(potentially culminating   completed suicide) in suicidal                (see section 4.4) ideations/thoughts or suicide attempts and completed suicide)
(see section 4.4)
Hallucinations


System/                   Common         Uncommon       Rare                  Very rare                Frequency organ class               > 1/100 to     > 1/1,000 to   > 1/10,000 to         < 1/10,000               unknown < 1/10         < 1/100        < 1/1,000                                      (cannot be estimated from the available data)
Nervous system                           Headache       Par- and              Migraine                 Peripheral Disorders*                               Dizziness      Dysesthesia           Disturbed coordination   neuropathy and Sleep          Hypoaesthesia         Gait disturbance         polyneuropathy (see disorders      Tremor                Olfactory nerve          section 4.4) Taste          Seizures (including   disorders disorders      status epilepticus)   Intracranial
(see                  hypertension and section 4.4)          pseudotumor cerebri
Vertigo
Eye disorders*                                          Visual                Visual colour disturbances (e.g.,   distortions diplopia)

Ear and labyrinth                                       Tinnitus disorders*                                              Hearing loss / hearing impaired


System/                   Common         Uncommon                Rare                        Very rare      Frequency organ class               > 1/100 to     > 1/1,000 to            > 1/10,000 to               < 1/10,000     unknown < 1/10         < 1/100                 < 1/1,000                                  (cannot be estimated from the available data)
Cardiac                                                          Tachycardia                                Ventricular Disorders**                                                                                                 arrhythmia and torsades de pointes
(reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see Section
4.4 and 4.9)

Vascular disorders**                                             Vasodilation                Vasculitis Hypotension Syncope
Respiratory,                                                     Dyspnoea thoracic and                                                     (including mediastinal                                                      asthmatic disorders                                                        condition) Gastro-intestinal         Nausea         Vomiting                Antibiotic-associated       Pancreatitis disorders                 Diarrhoea      Gastro-intestinal and   colitis (very rarely with abdominal pain          possible fatal outcome)
Dyspepsia Flatulence    (see section 4.4)


System/                   Common         Uncommon                 Rare                     Very rare                   Frequency organ class               > 1/100 to     > 1/1,000 to             > 1/10,000 to            < 1/10,000                  unknown < 1/10         < 1/100                  < 1/1,000                                            (cannot be estimated from the available data)
Hepatobiliary                            Increase in              Hepatic impairment       Liver necrosis disorders                                transaminases            Cholestatic icterus      (very rarely progressing Increased bilirubin      Hepatitis                to       life-threatening hepatic failure) (see section 4.4)

Skin and                                 Rash                     Photosensitivity         Petechiae                   Acute generalised subcutaneous tissue                      Pruritus                 reactions (see section   Erythema                    exanthematous disorders                                Urticaria                4.4)                     multiforme                  pustulosis (AGEP) Erythema nodosum            Drug Reaction with
Stevens-Johnson             Eosinophilia and
Syndrome (potentially       Systemic Symptoms life-threatening)           (DRESS)
Toxic epidermal necrolysis (potentially life-threatening)

Musculoskeletal and                       Musculo-skeletal pain   Myalgia                  Muscular weakness connective tissue                        (e.g.,                   Arthritis                Tendinitis disorders*                               extremity pain,          Increased                Tendon ruptures back pain                muscle tone and          (predominantly Achilles and chest pain)          cramping                 tendon) (see section Arthralgia                                        4.4) Exacerbation of symptoms of myasthenia gravis (see


System/                   Common                   Uncommon               Rare                 Very rare      Frequency organ class               > 1/100 to               > 1/1,000 to           > 1/10,000 to        < 1/10,000     unknown < 1/10                   < 1/100                < 1/1,000                           (cannot be estimated from the available data) section 4.4)


Renal and                                          Renal impairment       Renal failure urinary                                                                   Haematuria disorders                                                                 Crystalluria (see section 4.4)
Tubulointerstitial nephritis
General                   Injection and infusion   Asthenia               Oedema disorders                 site reactions (only     Fever                  Sweating and                       intravenous                                     (hyperhydrosis) administration            administration) site conditions*
Investigations                                     Increase in blood      Prothrombin level                   International alkaline phosphatase   abnormal                            normalised ratio Increased amylase                   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 preexisting 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 an intravenous or sequential (intravenous to oral) treatment: 
Common                 Vomiting, transient increase in transaminases, rash Uncommon               Thrombocytopenia, thrombocytaemia, confusion and disorientation, hallucinations, par-and dysaesthessia, seizures, vertigo, visual disturbances, hearing loss, tachycardia, vasodilatation, hypotension, transient hepatic impairment, cholestatic icterus, renal failure,
oedema
Rare                   Pancytopoenia, 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