Heptral Adverse Reactions

Clinical Trials: Ademetionine was studied in 2434 patients of whom 1983 were exposed to ademetionine with liver disease and 817 patients with depression, in controlled and open trials for up to 2 years.
The following adverse reactions are based on 1667 patients in 22 clinical trials treated with ademetionine, of whom 121 (7.2%) experienced a total of 188 adverse reactions. Nausea, abdominal pain and diarrhea were the most frequently reported adverse reactions. A causal relationship of the adverse event with the drug was not always assessable.
Infections and Infestations: Urinary tract infection.
Psychiatric Disorders: Confusion, insomnia.
Nervous System Disorders: Dizziness, headache, paresthesia.
Cardiac Disorders: Cardiovascular disorders.
Vascular Disorders: Hot flushes, superficial phlebitis.
Gastrointestinal Disorders: Abdominal distension and pain, diarrhea, dry mouth, dyspepsia, esophagitis, flatulence, gastrointestinal pain and hemorrhage, nausea, vomiting.
Hepatobiliary Disorders: Biliary colic, hepatic cirrhosis.
Skin and Subcutaneous Tissue Disorders: Hypehydrosis, pruritus, skin reactions.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, muscle spasms.
General Disorders and Administration Site Conditions: Asthenia, chills, injection site reactions, influenza-like illness, malaise, peripheral edema, pyrexia.
Post-Marketing Experience: Immune System Disorders: Anaphylactic reaction.
Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema.
Skin and Subcutaneous Tissue Disorders: Injection site reactions (very rarely with skin necrosis), rash, angioedema.