Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The adverse reactions observed with Diprospan, which are the same as those mentioned for other corticosteroids, are related to both dose and duration of treatment.

Among the adverse reactions to corticosteroids in general, the following effects are to be particularly noted:

Fluid and electrolyte disorders:
Sodium retention - Potassium loss - Hypokalemic alkalosis - Fluid retention - Congestive heart failure in susceptible patients - Hypertension;

Musculoskeletal disorders:
Muscular weakness - Loss of muscle mass - Aggravation of myasthenic symptoms in myasthenia gravis - Osteoporosis with sometimes severe bone pain and spontaneous fractures (vertebral compression fractures) - Aseptic bone necrosis (femoral and humeral head) - Tendon rupture - Steroid myopathy - Pathological fractures - Joint instability;

Skin disorders:
Skin atrophy - Delayed healing - Thin and fragile skin - Petechiae - Bruising - Allergic dermatitis - Angioneurotic edema - Facial erythema - Increased sweating - Urticaria; 
Digestive disorders:
Gastric ulcer with bleeding and possible perforation - Pancreatitis - Abdominal distension - Intestinal perforation - Ulcerative esophagitis - Nausea - Vomiting;

Neurological disorders:
Seizures - Vertigo - Headache - Migraines - Increased intracranial pressure (pseudotumor cerebri); 
Psychiatric disorders:
Euphoria - Mood Disorders - Personality changes and severe depression - Hyperirritability - Insomnia - Psychotic reactions especially in patients with a psychiatric history - Depression; 
Ophthalmic disorders:
Increased intraocular pressure (pseudotumor cerebri: see neurological); Glaucoma - Posterior subcapsular cataract - Exophthalmos - Vision blurred (see also section 4.4).

Endocrine disorders:
Clinical symptoms of Cushing's syndrome - Menstrual disorders - Increased need for insulin or oral antidiabetic agents in diabetics - Inhibition of fetal child growth - Reduced tolerance to carbohydrates - Signs of latent diabetes mellitus - Secondary inhibition of the pituitary and the adrenal cortex, especially harmful in case of stress (such as trauma, surgery and disease);

Metabolic disorders:
Negative nitrogen balance with protein degradation - Lipomatosis - Weight gain; 
Immunity disorders:
Corticosteroids can cause an inhibition of skin tests, mask the symptoms of infection and active a latent infection. They can also decrease resistance to infection, especially when due to mycobacteria, tuberculosis, Candida albicans or viruses.
Other:
Anaphylactic or allergic reactions, hypotensive reactions or reactions related to shock.

THE FOLLOWING ADVERSE REACTIONS MAY BE OBSERVED DURING PARENTERAL
CORTICOTHERAPY:
Rare cases of blindness associated with intralesional treatment of the face and head - Hyperpigmentation or hypopigmentation - Subcutaneous and cutaneous atrophy - Sterile abscess - Post-injection exacerbation (after intra-articular use) - Charcot arthropathy.

After repeated intra-articular administration, joint damage may occur. There is a risk of contamination.

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/