Adverse reactions : תופעות לוואי

4.8. Undesirable Effects

The following adverse reactions have been observed in patients receiving tetracyclines, including doxycycline.


System Organ Class      Common                   Uncommon                Rare                       Not known ≥ 1/100 to <1/10         ≥ 1/1,000 to <1/100     ≥ 1/10,000 to <1/1,000     (frequency cannot be estimated from the available data)
Blood and lymphatic                                                      Haemolytic anaemia, system disorders                                                         neutropenia, thrombocytopenia,
eosinophilia
Immune System           Hypersensitivity                                 Drug Reaction with Disorders               (including                                       Eosinophilia and anaphylactic
shock, anaphylactic                 Systemic Symptoms reaction,                           (DRESS), Jarisch- anaphylactoid                       Herxheimer reaction,                           reactionb (see angioedema,                         section 4.4) exacerbation of systemic lupus erythematosus (see section 4.4),
pericarditis, serum sickness, Henoch-
Schonlein purpura,
hypotension,
dyspnoea,
tachycardia,
peripheral oedema and urticaria)
Endocrine disorders                                       Brown-black microscopic discoloration of thyroid glands
Metabolism and                                            Decreased appetite nutrition disorders
Nervous System        Headache                            Benign intracranial Disorders                                                 hypertension (pseudotumor cerebri)a, fontanelle bulging
Ear and Labyrinth                                         Tinnitus
Disorders
Eye disorders                                             Visual disturbanced Vascular disorders                                        Flushing

Gastrointestinal      Nausea/vomiting       Dyspepsia,    Pancreatitis,              Tooth Disorders                                   (Heartburn/   pseudomembranous           discolouratione gastritis)    colitis, Clostridium difficile colitis,
oesophageal ulcer,
oesophagitis,
enterocolitis,
inflammatory lesions
(with monilial overgrowth) in the anogenital region,
dysphagia, abdominal pain, diarrhoea,
glossitis
Hepatobiliary                                             Hepatotoxicity, Disorders                                                 hepatitis,
hepatic function abnormal
Skin and              Photosensitivity                    Toxic epidermal Subcutaneous          reaction,                           necrolysis, Stevens- Tissue                Rash including                      Johnson syndrome, Disorders             maculopapular and                   erythema multiforme, erythematous                        dermatitis exfoliative,
rashes                              fixed drug eruption,
skin hyperpigmentationc,
photoonycholysis
Musculoskeletal and                                       Arthralgia, myalgia Connective Tissue
Disorders


Renal and Urinary                                                        Blood Urea Disorders                                                                Increased 
CIOMS III categories:
Common >1/100 to <1/10 (>1% and <10%),
Uncommon >1/1,000 to <1/100 (>0.1% and <1%),
Rare >1/10,000 to <1/1,000 (>0.01% and <0.1%),
Not known (frequency cannot be estimated from the available data)
 a In association with tetracyclines, including doxycycline, benign intracranial hypertension has been reported with possible symptoms of headache, vomiting, visual disturbances including blurred vision, scotoma, diplopia or permanent loss of vision. The manifestation of clinical symptoms, including headache or visual disturbances, should suggest a possible diagnosis of intracranial hypertension. If an increase in intracranial pressure is suspected during treatment with tetracyclines, administration should be discontinued.
b in the setting of spirochete infections treated with doxycycline.
c with chronic use of doxycycline.
d Associated with Benign intracranial hypertension (pseudotumor cerebri).
e Reversible and superficial discolouration of permanent teeth has been reported with the use of doxycycline but  frequency cannot be estimated from available data.

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