Adverse reactions : תופעות לוואי

4.8 Undesirable effects
a. Summary of the safety profile
The most commonly reported adverse reactions in patients treated with fluoxetine were headache, nausea, insomnia, fatigue and diarrhoea. Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
b. Tabulated list of adverse reactions
The table below gives the adverse reactions observed with fluoxetine treatment in adult and paediatric populations. Some of these adverse reactions are in common with other SSRIs.
The following frequencies have been calculated from clinical trials in adults (n = 9297) and from spontaneous reporting.
Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).
Very Common         Common              Uncommon                Rare                     Not Known Blood and lymphatic system disorders
Thrombocytopenia
Neutropenia
Leucopenia
Immune system disorders
Anaphylactic reaction
Serum sickness
Endocrine disorders
Inappropriate
antidiuretic hormone
secretion
Metabolism and nutrition disorders
Decreased appetite1                       Hyponatraemia
Psychiatric disorders
Insomnia2            Anxiety               Depersonalisation   Hypomania Nervousness           Elevated mood       Mania
Restlessness          Euphoric mood       Hallucinations
Tension               Thinking abnormal   Agitation
Libido decreased3     Orgasm abnormal5    Panic attacks
Sleep disorder        Bruxism             Confusion
Abnormal dreams4      Suicidal thoughts   Dysphemia
and behaviour 6     Aggression
Nervous system disorders
Headache             Disturbance in        Psychomotor         Convulsion                Hypoesthesia attention             hyperactivity       Akathisia
Dizziness             Dyskinesia          Buccoglossal
Dysgeusia             Ataxia              syndrome
Lethargy              Balance disorder    Serotonin syndrome
Somnolence7           Myoclonus
Tremor                Memory impairment
Eye disorders
Vision blurred        Mydriasis
Ear and labyrinth disorders
Tinnitus
Cardiac disorders
Palpitations                              Ventricular arrhythmia
Electrocardiogram                         including torsades de
QT prolonged (QTcF                        pointes
≥450 msec)8
Vascular disorders
Flushing9             Hypotension         Vasculitis
Vasodilatation
Respiratory, thoracic and mediastinal disorders
Yawning               Dyspnoea            Pharyngitis
Epistaxis           Pulmonary events
Dysphonia           (inflammatory
processes of varying
histopathology and/or
fibrosis)10
Gastrointestinal disorders
Diarrhoea            Vomiting              Dysphagia           Oesophageal pain Nausea               Dyspepsia             Gastrointestinal
Dry mouth             haemorrhage11
Hepato-biliary disorders
Idiosyncratic hepatitis
Skin and subcutaneous tissue disorders
Rash12                Alopecia            Angioedema                Erythromelalgia Urticaria                                 Ecchymosis
Pruritus               Increased tendency     Photosensitivity
Hyperhidrosis          to bruise              reaction
Cold sweat             Purpura
Erythema multiforme
Stevens-Johnson
syndrome
Toxic Epidermal
Necrolysis (Lyell
Syndrome)
Musculoskeletal and connective tissue disorders
Arthralgia             Muscle twitching       Myalgia
Renal and urinary disorders
Frequent urination13 Dysuria                  Urinary retention
Micturition disorder
Reproductive system and breast disorders
Gynaecological         Sexual dysfunction     Galactorrhoea             Postpartum haemorrhage16 bleeding14                                    Hyperprolactinaemia
Erectile dysfunction                          Priapism
Ejaculation
disorder15
General disorders and administration site conditions
Fatigue17           Feeling jittery        Malaise                Mucosal haemorrhage Chills                 Feeling abnormal
Feeling cold
Feeling hot
Investigations
Weight decreased       Transaminases
increased
Gamma-
glutamyltransferase
increased
Abnormal liver
function tests
1 Includes anorexia
2 Includes early morning awakening, initial insomnia, middle insomnia
3 Includes loss of libido
4 Includes nightmares
5 Includes anorgasmia
6 Includes completed suicide, depression suicidal, intentional self-injury, self-injurious ideation, suicidal 
behaviour, suicidal ideation, suicide attempt, morbid thoughts, self-injurious behaviour. These symptoms may be due to underlying disease
7 Includes hypersomnia, sedation
8 Based on ECG measurements from clinical trials
9 Includes hot flush
10 Includes atelectasis, interstitial lung disease, pneumonitis
11 Includes most frequently gingival bleeding, haematemesis, haematochezia, rectal haemorrhage, 
diarrhoea haemorrhagic, melaena, and gastric ulcerhaemorrhage
12 Includes erythema, exfoliative rash, heat rash, rash, rash erythematous, rash follicular, rash 
generalized, rash macular, rash macular-papular, rash morbilliform, rash papular, rash pruritic, rash vesicular, umbilical erythema rash
13 Includes pollakiuria
14 Includes cervix haemorrhage, uterine dysfunction, uterine bleeding, genital haemorrhage, menometrorhagia, menorrhagia, metrorrhagia, polymenorrhea, postmenopausal haemorrhage, uterine haemorrhage, vaginal haemorrhage
15 Includes ejaculation failure, ejaculation dysfunction, premature ejaculation, ejaculation delayed, 
retrograde ejaculation
16 This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).
17 Includes asthenia

c. Description of selected adverse reactions
Suicide/suicidal thoughts or clinical worsening: Cases of suicidal ideation and suicidal behaviour have been reported during fluoxetine therapy or early after treatment discontinuation (see section 4.4).
Bone fractures: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to the risk is unknown.
Withdrawal symptoms seen on discontinuation of fluoxetine treatments: Discontinuation of fluoxetine commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged (see section 4.4). It is therefore advised that when Prizma Solution treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 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