Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable effects are dose dependent and are often transient in nature with continued treatment.

Table 1 displays adverse reactions observed from post-marketing experience (frequency not known) and placebo-controlled clinical trials (comprising a total of 2542 patients on sertraline and 2145 on placebo) in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.

Table 1: Adverse Reactions
Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience.
System Organ            Very             Common            Uncommon                   Rare             Frequency Class             Common             (≥1/100 to        (≥1/1,000 to           (≥1/10,000 to        Not Known (≥1/10)             <1/10)            <1/100)                <1/1,000)          (Cannot be Estimated
From the
Available
Data)
Infections and                        upper               gastroenteritis,     diverticulitis§ infestations                          respiratory tract   otitis media infection,
pharyngitis,
rhinitis
Neoplasms                                                 neoplasm benign,
malignant and unspecified
(including cysts and polyps)
Blood and                                                                      lymphadenopathy, lymphatic                                                                      thrombocytopenia§, system disorders                                                               leukopenia§ Immune system                                             hypersensitivity,   anaphylactoid disorders                                                 seasonal allergy    reaction Endocrine                                                 hypothyroidism      hyperprolactinaemia disorders                                                                      § , inappropriate antidiuretic hormone secretion§
Metabolism and                        decreased                                hypercholesterolaemi nutrition                             appetite,                                a, diabetes mellitus, disorders                             increased                                hypoglycaemia, appetite                                hyperglycaemia§,
hyponatraemia§

                                   Table 1: Adverse Reactions
Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience.
System Organ            Very             Common           Uncommon                    Rare             Frequency Class             Common             (≥1/100 to       (≥1/1,000 to            (≥1/10,000 to        Not Known (≥1/10)             <1/10)           <1/100)                 <1/1,000)          (Cannot be Estimated
From the
Available
Data)
Psychiatric            insomnia   anxiety*,              suicidal              conversion disorder§, disorders                         depression*,           ideation/behaviour,   paroniria§, drug agitation*,            psychotic             dependence, sleep libido                 disorder, thinking walking, premature decreased*,            abnormal, apathy,
hallucination*,
ejaculation nervousness,
aggression*,
depersonalisatio       euphoric mood*,
n, nightmare,          paranoia bruxism*
Nervous system         dizziness, tremor,                amnesia,              coma*, akathisia disorders              headache*, movement               hypoaesthesia*,       (see section 4.4), somnolenc disorders               muscle                dyskinesia,
e          (including             contractions          hyperaesthesia, extrapyramidal         involuntary*,
cerebrovascular symptoms such          syncope*,
hyperkinesia*,
spasm (including as hyperkinesia,
migraine*,            reversible cerebral hypertonia,
convulsion*,          vasoconstriction dystonia, teeth grinding or gait       dizziness             syndrome and Call- abnormalities),        postural,             Fleming paraesthesia*,         coordination          syndrome)§,
hypertonia*,           abnormal, speech      psychomotor disturbance in         disorder              restlessness§ (see attention,                                   section 4.4),
dysgeusia                                    sensory disturbance,
choreoathetosis§,
also reported were signs and symptoms associated with serotonin syndrome or neuroleptic malignant syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation,
                                   Table 1: Adverse Reactions
Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience.
System Organ            Very             Common           Uncommon                  Rare             Frequency Class             Common             (≥1/100 to       (≥1/1,000 to          (≥1/10,000 to        Not Known (≥1/10)             <1/10)           <1/100)               <1/1,000)          (Cannot be Estimated
From the
Available
Data) confusion,
diaphoresis,
diarrhoea, fever,
hypertension,
rigidity and tachycardia§
Eye disorders                         visual             mydriasis          scotoma, glaucoma,       maculopathy disturbance                           diplopia, photophobia,
hyphaema§, pupils unequal§, vision abnormal§, lacrimal disorder
Ear and                               tinnitus          ear pain labyrinth disorders
Cardiac                               palpitations      tachycardia,       myocardial disorders                                                cardiac disorder    infarction§, Torsade de Pointes§ (see sections 4.4, 4.5 and
5.1), bradycardia,
QTc prolongation
(see sections 4.4, 4.5 and 5.1)
Vascular                              hot flush         abnormal            peripheral ischaemia disorders                                                bleeding (such as gastrointestinal bleeding),
hypertension,
flushing,
haematuria
Respiratory,                          yawning           dyspnoea,           hyperventilation, thoracic and                                             epistaxis,         interstitial lung mediastinal                                              bronchospasm*       disease§, disorders                                                                    eosinophilic pneumonia*§,
laryngospasm,
dysphonia, stridor§,
hypoventilation,
hiccups
Gastrointestinal       nausea,        dyspepsia,       melaena, tooth        mouth ulceration,        colitis disorders              diarrhoea,                 * constipation ,   disorder,             pancreatitis§,          microscopic dry mouth      abdominal pain*, oesophagitis,         haematochezia,           * 
                                   Table 1: Adverse Reactions
Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience.
System Organ            Very             Common           Uncommon                  Rare            Frequency Class             Common             (≥1/100 to       (≥1/1,000 to          (≥1/10,000 to       Not Known (≥1/10)             <1/10)           <1/100)               <1/1,000)         (Cannot be Estimated
From the
Available
Data) vomiting*,         glossitis,          tongue ulceration,
flatulence         haemorrhoids,       stomatitis salivary hypersecretion,
dysphagia,
eructation,
tongue disorder
Hepatobiliary                                                                hepatic function disorders                                                                    abnormal, serious liver events
(including hepatitis,
jaundice and hepatic failure)
Skin and                              hyperhidrosis,     periorbital         rare reports of subcutaneous                          rash*              oedema*,            severe cutaneous tissue disorders                                         urticaria*,         adverse reactions alopecia*,          (SCAR): e.g.
pruritus*,          Stevens-Johnson purpura*,           syndrome and dermatitis, dry     epidermal skin, face          necrolysis§, skin oedema, cold        reaction§,
sweat               photosensitivity§,
angioedema, hair texture abnormal,
skin odour abnormal,
dermatitis bullous,
rash follicular
Musculoskeletal                       back pain,         osteoarthritis,     rhabdomyolysis§,       trismus* and connective                        arthralgia,       muscle twitching,   bone disorder tissue disorders                      myalgia            muscle cramps, muscular weakness
Renal and                                                pollakiuria,        urinary hesitation*, urinary                                                  micturition         oliguria disorders                                                disorder,
urinary retention,
urinary incontinence*,
                                   Table 1: Adverse Reactions
Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience.
System Organ            Very             Common           Uncommon                 Rare           Frequency Class             Common             (≥1/100 to       (≥1/1,000 to         (≥1/10,000 to      Not Known (≥1/10)             <1/10)           <1/100)              <1/1,000)        (Cannot be Estimated
From the
Available
Data) polyuria,
nocturia
Reproductive           ejaculatio     menstruation       sexual             galactorrhoea*,        postpartum system and             n failure      irregular,        dysfunction (see   atrophic               haemorrhage *† breast disorders                      erectile           section 4.4),      vulvovaginitis, dysfunction        menorrhagia,       genital discharge,
vaginal            balanoposthitis§,
haemorrhage,       gynaecomastia,
priapism* female sexual dysfunction (see section 4.4)
General                fatigue*       malaise*,          oedema             hernia, drug disorders and                         chest pain*,       peripheral*,       tolerance decreased administration                        asthenia,         chills, gait site conditions                       pyrexia           disturbance, thirst
Investigations                        weight             alanine            blood cholesterol increased         aminotransferase   increased, abnormal increased*,        clinical laboratory aspartate          results, semen aminotransferase   abnormal, altered increased*,        platelet function§ weight decreased*
Injury,                          injury poisoning and procedural complications
Surgical and                                                             vasodilation medical                                                                  procedure procedures

ADR identified post-marketing
§
ADR frequency represented by the estimated upper limit of the 95% confidence interval using “The Rule of 3”.
†
This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).


Withdrawal symptoms seen on discontinuation of sertraline treatment
Discontinuation of sertraline (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported. Generally these events are mild to moderate and are self-limiting; however, in some patients they may be severe and/or prolonged. It is therefore advised that when sertraline treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).

Elderly population
SSRIs or SNRIs including sertraline have been associated with cases of clinically significant hyponatraemia in elderly patients, who may be at greater risk for this adverse event (see section 4.4).


Class effects
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 this risk is unknown.

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.