Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most commonly reported side effects with extracorporea use of methoxsalen were phototoxic reactions, nausea, vomiting, congestive heart failure and hypotension. During the course of therapy, the severity and frequency of undesirable effects may decline and generally do not require discontinuation of the therapy.

Very common:           ≥1/10
Common:                ≥1/100 to <1/10
Uncommon:              ≥1/1,000 to <1/100
Rare:                  ≥1/10,000 to <1/1,000
Very rare:             <1/10,000
Not known:             Frequency cannot be estimated from the available data 
Not known
Common
(Frequency cannot be estimated from the available
(≥ 1/100 to < 1/10) data)
Infections and infestations
Infections
Eye disorders
Phototoxic reactions, e.g. cataract     formation,
chorioretinitis (see section 4.4)
Vascular disorders
Hypotension
Dizziness
Gastrointestinal disorders
Nausea
Vomiting
Skin and subcutaneous tissue disorders
Phototoxic reactions, e.g. pruritus or erythema (see section 4.4)
General disorders and administration site conditions
Fever (2 to 12 hours after therapy low grade fever may occur)
Injury, poisoning and procedural complications
Venous access complication after repeated venipuncture

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