ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026🚩 Report this page

Phenindione

Vitamin K Antagonists

GB MHRA

Drug class: Vitamin K Antagonists
Availability: See label
Markets covered: 1
Products on record: 2

Overview

Phenindione is an active pharmaceutical ingredient in the Vitamin K Antagonists group (B01AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	April 10, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised April 10, 2026[1]

Dindevan (Phenindione BP) is a synthetic anticoagulant which acts by interfering with the formation of clotting factors II, VII, IX and X. It produces its effect in 36-48 hours after the initial dose; the effect wanes over a period of 48-72 hours after Dindevan is stopped.
Anticoagulant therapy can be initiated with Heparin and Dindevan together. Anticoagulant therapy in the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.

How to take

Sources & citations

[1]MHRA (UK) · PL109720038 · revised April 10, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Phenindione: Uses, Side Effects, Dosage - Drugvu

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[1]

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: 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 (cannot be estimated from the available data) The following undesirable effects have been reported: System organ class database Frequency Adverse reactions Infections and infestations Not known Fever Blood and lymphatic system disorders Not known leucopenia; agranulocytosis*; lymphadenopathy*; eosinophilia*; Leukocytosis*; Pancytopenia*; leukaemoid syndrome* Immune system disorders Not known Hypersensitivity Nervous system disorders Not known Cerebral haemorrhage; cerebral subdural haematoma Vascular disorders Not known Haemorrhage Respiratory, thoracic and mediastinal disorders Not known Haemothorax, epistaxis Gastrointestinal disorders Not known Gastrointestinal haemorrhage, rectal haemorrhage, haematemesis; pancreatitis; diarrhoea; nausea; vomiting; melaena; Dysgeusia Hepatobiliary disorders Not known Hepatitis, jaundice* Skin and subcutaneous tissue disorders Not known Rash*, purpura; Blue toe syndrome; ecchymosis; alopecia*; skin necrosis*; dermatitis exfoliative*, exanthema.
Renal and Urinary disorders Not known Haematuria; renal damage with tubular necrosis*; albuminuria* Investigations Not known Haematocrit decreased; haemoglobin decreased *These events have been reported in relation to hypersensitivity reactions.
If any of the above effects are found, Dindevan therapy should be stopped immediately, and a full investigation of blood, liver and renal function should be undertaken. Possible sensitivity to other drugs should be considered. Other anticoagulants, such as warfarin, are tolerated usually by patients sensitive to Dindevan.
An episode of bleeding during anticoagulant therapy must be investigated fully and not regarded automatically as a manifestation of overdosage. The metabolites of Dindevan often colour the urine pink or orange. This effect may be distinguished from discoloration caused by haemoglobin by the addition of a few drops of dilute acetic acid to the urine.
If the discoloration is due to Dindevan, the discoloration will disappear immediately. 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.
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GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[1]

Most adverse events reported with Dindevan are a result of allergic reactions or over anticoagulation therefore it is important that the need for therapy is reviewed on a regular basis and therapy discontinued when no longer required.
Patients should be made aware of the symptoms of allergic reactions and told to seek medical advice if they experience any signs of allergic reactions. Patients should be given a patient-held information booklet (‘anticoagulant card’) and informed of symptoms for which they should seek medical attention.
5) Calciphylaxis is a rare syndrome of vascular calcification with cutaneous necrosis, associated with high mortality. The condition is mainly observed in patients with end-stage renal disease on dialysis or in patients with known risk factors such as protein C or S deficiency, hyperphosphataemia, hypercalcaemia or hypoalbuminaemia.
Rare cases of calciphylaxis have been reported in patients taking vitamin K antagonists, also in the absence of renal disease. In case calciphylaxis is diagnosed, appropriate treatment should be started and consideration should be given to stopping treatment with Dindevan.
Monitoring When Dindevan is started using a standard dosing regimen, the INR should be determined daily or on alternate days in the early days of treatment. Once the INR has stabilized in the target range, the INR can be determined at longer intervals.
g. patients with severe hypertension, liver or renal disease. Patients for whom adherence may be difficult should be monitored more frequently. Thrombophilia Patients with protein C deficiency are at risk of developing skin necrosis when starting Dindevan treatment.
In patients with protein C deficiency, therapy should be introduced without a loading dose of Dindevan even if heparin is given. Patients with protein S deficiency may also be at risk and it is advisable to introduce Dindevan therapy slowly in these circumstances.
Risk of haemorrhage The most frequently reported adverse effect of all oral anticoagulants is haemorrhage. g. concomitant NSAID use, recent ischaemic stroke, bacterial endocarditis, previous gastrointestinal bleeding). 5). All patients treated with Dindevan should have INR monitored regularly.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations