Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Side effects are generally mild to moderate, and transient. The following adverse reactions have been observed in the clinical trials or during post-marketing experience.
Adverse reactions are ranked under headings of frequency, using the following convention:
Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, <1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000), Not known (frequency cannot be estimated from available data).

Blood and lymphatic system disorders
Very rare                                    Neutropenia, agranulocytosis, thrombocytopenia.

Not known                                    Anaemia Pancytopenia
Immune system disorders
Anaphylactoid reactions (including angioedema),
Very rare cutaneous and systemic lupus erythematosus.
Not known                                    Anaphylactic reaction, serum sickness-like reaction.
Metabolism and nutrition disorders
Very common                                  Decreased appetite

Psychiatric disorders

Not known                                    Anxiety and depressive symptoms 
Nervous system disorders

Common                                       Headache
Dysgeusia* including ageusia*
* Hypogeusia, including ageusia, which usually recover
Uncommon                                     within several weeks after discontinuation of the drug.
Isolated cases of prolonged hypogeusia have been reported.
Rare                                         Paraesthesia, hypoaesthesia, dizziness 
Not known                                    Anosmia including permanent anosmia, hyposmia.
Eye disorders

Not known                                    Visual impairment, vision blurred, visual acuity reduced 
Ear and labyrinth disorders

Very rare                                    Vertigo
Not known                                    Hypoacusis, impaired hearing, tinnitus 
Vascular disorders

Not known                                    Vasculitis
Gastrointestinal disorders
Gastrointestinal symptoms (feeling of fullness abdominal
Very common                                  distension, dyspepsia, nausea, abdominal pain, diarrhoea).
Not known                                    Pancreatitis

Hepatobiliary disorders
Cases of serious hepatic dysfunction, including hepatic failure, hepatic enzymes increased, jaundice, cholestasis and hepatitis. If hepatic dysfunction develops, treatment with oral terbinafine should be discontinued (see also
Section 4.4). Very rare cases of serious liver failure have
Rare been reported (some with a fatal outcome, or requiring liver transplant). In the majority of liver failure cases the patients had serious underlying systemic conditions and a causal association with the intake of oral terbinafine was uncertain.
Skin and subcutaneous tissue disorders
Very common                                  Rash, urticaria
Stevens-Johnson syndrome, toxic epidermal necrolysis,
erythema multiforme, toxic skin eruption, dermatitis exfoliative, dermatitis bullous.
Very rare                                    Photosensitivity reactions Alopecia
If progressive skin rash occurs, oral terbinafine treatment should be discontinued.
Psoriasiform eruptions or exacerbation of psoriasis.
Serious skin reactions (e.g. acute generalized
Not known exanthematous pustulosis (AGEP)).
Drug rash with eosinophilia and systemic symptoms
Musculoskeletal and connective tissue disorders
Very common                                  Musculoskeletal reactions (arthralgia, myalgia).

Not known                                    Rhabdomyolysis

General disorders
Rare                                         Malaise
Fatigue
Not known
Influenza-like illness, pyrexia
Investigations
Weight decreased**
Uncommon
**weight decreased secondary to dysgeusia
Not known                                    Blood creatine phosphokinase increased 

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