Chemical formula: C₁₅H₂₂N₆O₅S Molecular mass: 398.44 g/mol PubChem compound: 34755
The use of high doses of ademetionine in women in the last three months of pregnancy did not lead to any adverse effect. It is advisable to administer ademetionine in the first three months of pregnancy only if it is absolutely necessary.
Ademetionine should be used while breast-feeding only if the potential benefit justifies the potential risk to the infant.
Some patients may experience dizziness with the use of ademetionine. Patients should be advised not to drive or operate machinery during treatment until they are reasonably certain that ademetionine therapy does not affect their ability to engage in such activities.
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 table is 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.
| System Organ Class (SOC) | Preferred Term |
|---|---|
| Infections and infestations | Urinary tract infection |
| Psychiatric disorders | Confusion Insomnia |
| Nervous system Disorders | Dizziness Headache Paresthesia |
| Cardiac disorders | Cardiovascular disorder |
| Vascular disorders | Hot flush Superficial phlebitis |
| Gastrointestinal disorders | Abdominal distension Abdominal pain Diarrhea Dry mouth Dyspepsia Esophagitis Flatulence Gastrointestinal pain Gastrointestinal disorder Gastrointestinal hemorrhage Nausea Vomiting |
| Hepato-biliary disorders | Biliary colic Hepatic cirrhosis |
| Skin and subcutaneoustissue disorders | Hyperhydrosis 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 |
Immune system disorders: Hypersensitivity, Anaphylactoid reactions or anaphylactic reactions (e.g. flushing, dyspnea, bronchospasm, back pain, chest discomfort, alterations in blood pressure [hypotension, hypertension] or pulse rate [tachycardia, bradycardia]).
Psychiatric disorders: Anxiety
Respiratory, thoracic and mediastinal disorders: Laryngeal edema
Skin and subcutaneous tissue disorders: Injection site reaction (very rarely with skin necrosis), angioedema, allergic skin reactions (e.g. rash, pruritus, urticaria, erythema).
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