Adverse reactions : תופעות לוואי

4.8 Undesirable Effects
Adverse reactions attributed to the antihistamine component (dexchlorpheniramine maleate) Slight to moderate drowsiness is the most frequent side effect of dexchlorpheniramine maleate.
Other reported reactions associated with antihistamine therapy in general include: 
General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat

Cardiovascular: Hypotension, hypertension, headache, palpitations, tachycardia, extrasystoles 
Haematological: Haemolytic anaemia, hypoplastic anaemia, thrombocytopenia, agranulocytosis

Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation 
Genitourinary: Urinary frequency, difficult urination, urinary hesitation and retention, early menses

Nervous System: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paraesthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions, lassitude, depression, inability to concentrate, dilated pupils, hypereflexia, hyporeflexia, xerostomia, hallucinations, appetite stimulation, anxiety, facial dyskinesias and seizures 
Respiratory: Thickening of bronchial secretions, tightness of chest, wheezing, nasal stuffiness 

Adverser Reactions attributed to pseudoepehdrine component
Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with pseudoephedrine are listed below by System Organ Class (SOC).
The frequencies are defined according, to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.

System Organ Class (SOC)                    Frequency   Adverse Drug Reaction (Preferred Term) Blood and lymphatic system                  Not known   Blood disorders, blood dyscrasias (including disorders                                               agranulocytosis and thrombocytopenia) have been reported following paracetamol use but were not necessarily causally related to the drug
Immune System Disorders                     Rare        Hypersensitivity (cross-sensitivity may occur with other sympathomimetics)
Psychiatric Disorders                       Common      Insomnia
Nervousness
Not known   Anxiety
Euphoric mood
Excitability
Hallucination
Irritability
Paranoid delusions
Restlessness
Sleep disorder
Nervous System Disorders                    Very        Headache common
Common      Dizziness
Not known   Cerebrovascular accident
Paraesthesia
Posterior reversible encephalopathy syndrome
(PRES) / Reversible cerebral vasoconstriction syndrome (RCVS)
Psychomotor hyperactivity
Somnolence
Tremor
Eye Disorders                               Not known   Ischaemic optic neuropathy Cardiac Disorders                           Not known   Dysrhythmias Myocardial infarction/Myocardial ischaemia
Palpitations
Tachycardia
Vascular Disorders                          Not known   Hypertension Gastrointestinal Disorders                  Common      Dry mouth
Nausea
Not known   Abdominal pain
Diarrhoea
Ischaemic colitis
Vomiting

Hepatobiliary disorders                     Rare      Hepatic necrosis Skin and Subcutaneous                       Not known Angioedema
Tissue Disorders                                      Fixed eruption Pruritus
Rash pruritic
Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP)
Urticaria
Rare      Rash
Renal and Urinary                           Uncommon Nephropathy toxic Disorders                                   Not known Dysuria
Renal papillary necrosis (after prolonged administration)Urinary retention (in men - prostatic enlargement could have been an important predisposing factor)

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