For Alkeran Tablet, there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects.
Undesirable effects may vary in their incidence depending on the indication and dose received and also when given in combination with other therapeutic agents.
The following convention has been utilised for the classification of frequency: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10,000 and <1/1000; very rare <1/10,000.
Blood and Lymphatic System Disorders: Very Common: Bone marrow depression leading to leucopenia, thrombocytopenia.
Rare: Haemolytic anaemia.
Immune System Disorders: Rare: Allergic reactions (see Skin and Subcutaneous Tissue Disorders).
Allergic reactions to melphalan eg, urticaria, oedema, skin rashes and anaphylactic shock have been reported uncommonly following initial or subsequent dosing, particularly after IV administration. Cardiac arrest has also been reported rarely in association with such events.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Interstitial pneumonitis and pulmonary fibrosis (including fatal reports).
Gastrointestinal Disorders: Very Common: Nausea, vomiting and diarrhoea; stomatitis at high dose.
Rare: Stomatitis at conventional dose.
Gastrointestinal effects eg, nausea and vomiting have been reported in up to 30% of patients receiving conventional oral doses of melphalan.
Hepatobiliary Disorders: Rare: Hepatic disorders ranging from abnormal liver function tests to clinical manifestations eg, hepatitis and jaundice.
Skin and Subcutaneous Tissue Disorders: Very Common: Alopecia at high dose.
Common: Alopecia at conventional dose.
Rare: Maculopapular rashes and pruritus (see Immune System Disorders).
Renal and Urinary Disorders: Common: Temporary significant elevation of the blood urea has been seen in the early stages of melphalan therapy in myeloma patients with renal damage.