Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Tablets:
Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed below

IV:
Adverse reactions observed in clinical trials and derived from post-marketing reports with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] and oral administration) sorted by frequencies are listed below:
Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as:
- common ( 1/100 to < 1/10)
- uncommon ( 1/1,000 to < 1/100)
- rare ( 1/10,000 to < 1/1,000)
- very rare (< 1/10,000)
- not known (cannot be estimated from the available data)
System Organ           Common         Uncommon                   Rare           Very Rare         Not known Class (MedDRA)
Infections and     Superinfections
infestations       due to resistant
bacteria or
fungi
e.g. oral and
vaginal
candidiasis
Blood and                             Anaemia                                   Prothrombin lymphatic system                      Leucopenia(s)                             level disorders                             Neutropenia                               increased/INR Thrombocytopenia                          decreased
Thrombocythemia                           Agranulocytosis
Blood eosinophilia                        Pancytopenia
Prothrombin time
prolonged/INR
increased
Immune system                         Allergic reaction    Anaphylaxis incl.
disorders                             (see section 4.4)    very rarely life- threatening shock
(see section 4.4)
Allergic oedema/
angiooedema (incl.
laryngeal oedema,
potentially life-
threatening, see
section 4.4)
Endocrine                                                                       Syndrome of disorders                                                                      inappropriate antidiuretic
hormone
secretion
(SIADH)
Metabolism and                        Hyperlipidemia       Hyperglycemia        Hypoglycemia nutrition                                                  Hyperuricemia      Hypoglycaemic disorders                                                                     coma Psychiatric                           Anxiety reactions    Emotional lability Depersonalization disorders*                            Psychomotor          Depression (in     Psychotic hyperactivity/       very rare cases    reactions
agitation            potentially        (potentially
culminating in     culminating in
self-injurious     self-injurious
behaviour, such    behaviour, such
as suicidal        as suicidal
ideations/         ideations/
thoughts, or       thoughts, or
suicide attempts, suicide attempts,
see section 4.4)   see section 4.4)
Hallucination
Delirium
System Organ            Common              Uncommon                Rare               Very Rare        Not known Class (MedDRA)
Nervous system      Headache             Par- and             Hypoaesthesia        Hyperaesthesia disorders*          Dizziness            Dysaesthesia         Smell disorders Taste disorders      (incl. anosmia)
(incl. ageusia in    Abnormal
very rare cases)     dreams
Confusion and        Disturbed
disorientation       coordination
Sleep disorders      (incl. gait
(predominantly       disturbances, esp.
insomnia)            due to dizziness
Tremor               or vertigo)
Vertigo              Seizures incl.
Somnolence           grand mal
convulsions (see
section 4.4)
Disturbed
attention
Speech disorders
Amnesia
Peripheral
neuropathy and
polyneuropathy
Eye disorders*                           Visual              Photophobia           Transient loss of disturbances                              vision (especially
incl. diplopia                            in the course of
and blurred                               CNS reactions,
vision                                    see sections 4.4
(especially in                            and
the course of                             4.7)
CNS reactions,                            Uveitis and
see section                               bilateral acute
4.4)                                      iris
transillumination
(see section 4.4)
Ear and labyrinth                                            Tinnitus disorders*                                                   Hearing
impairment
incl.
deafness
(usually
reversible)
Cardiac             QT prolongation in   QT                  Ventricular           Unspecified disorders**         patients with        prolongation        tachyarrhythmias      arrhythmias hypokalaemia (see    (see section        Syncope (i.e.,        Torsade de sections 4.3 and     4.4)                acute and short       Pointes (see                     4.4)                 Palpitations        lasting loss of       section 4.4)
Tachycardia         consciousness)        Cardiac arrest
Atrial                                    (see
fibrillation                              section 4.4)
Angina pectoris
Vascular                                 Vasodilatation      Hypertension          Vasculitis disorders                                                    Hypotension **
Respiratory,   Dyspnea
thoracic and   (including
mediastinal    asthmatic
disorders      conditions)
System Organ            Common            Uncommon              Rare                Very Rare          Not known Class (MedDRA)
Gastrointestinal    Nausea             Decreased        Dysphagia
disorders           Vomiting           appetite and     Stomatitis
Gastrointestinal   food intake      Antibiotic
and abdominal      Constipation     associated colitis
pains              Dyspepsia        (incl. pseudo-
Diarrhoea          Flatulence       membranous
Gastritis        colitis, in very rare
Increased        cases associated
amylase          with life-
threatening
complications, see
section 4.4)
Hepatobiliary       Increase in        Hepatic          Jaundice                Fulminant disorders           transaminases      impairment       Hepatitis               hepatitis (incl. LDH       (predominantly          potentially
increase)        cholestatic)            leading to life-
Increased                                threatening liver
bilirubin                                failure (incl.
Increased                                fatal cases, see
gamma-                                   section 4.4)
glutamyl-
transferase
Increase in
blood alkaline
phosphatase
Skin and                               Pruritus Rash                            Bullous skin        Acute subcutaneous                           Urticaria                                reactions like      Generalised tissue disorders                       Dry skin                                 Stevens-            Exanthematous Johnson             Pustulosis
syndrome or         (AGEP)
toxic epidermal
necrolysis
(potentially
life-
threatening,
see
section 4.4)
Musculoskeletal                        Arthralgia       Tendonitis (see         Tendon              Rhabdomyolysis and connective                         Myalgia          section 4.4)            rupture (see tissue disorders*                                       Muscle cramp            section 4.4) Muscle twitching        Arthritis
Muscle weakness         Muscle
rigidity
Exacerbation
of symptoms
of
myasthenia
gravis (see
section 4.4)
Renal and                              Dehydration      Renal impairment urinary disorders                                       (incl. increase in BUN and
creatinine)
Renal failure (see
section 4.4)
General disorders   For IV only:          Feeling unwell Oedema
and                 Injection and         (predominantl
administration      infusion site         y asthenia or
site conditions*    reactions             fatigue)
Painful
conditions
(incl. pain in
back, chest,
pelvic and
extremities)
Sweating
for IV only:
Infusion site
(thrombo-)
phlebitis
*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 subgroup of IV treated patients with or without subsequent oral therapy:
Common:         Increased gamma-glutamyl-transferase
Uncommon        Ventricular tachyarrhythmias, hypotension, oedema, antibiotic-associated colitis (incl.
pseudomembranous colitis, in very rare cases associated with life-threatening complications, see section 4.4), seizures incl. grand mal convulsions (see section 4.4), hallucination, renal impairment (incl. increase in BUN and creatinine), renal failure (see section 4.4) 

There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: increased intracranial pressure (including pseudotumor cerebri), hypernatraemia, hypercalcaemia, haemolytic anaemia, photosensitivity reactions (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/