Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis when other therapy is unsuitable

Ankylosing spondylitis

Only to be used by a specialist in severe cases where other treatments have been found unsuitable (risk of serious side effects in particular haematological reactions).

Contraindications

Children under 14 years
Haemorrhagic diathesis
Oedema
Asthma, urticaria or acute rhinitis associated with NSAIDS
Haematological disorder
Hereditary fructose intolerance
History of gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
Hypertension
Inflammatory bowel disease
Peptic ulcer
Respiratory impairment
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment
Sjogren's syndrome
Third trimester of pregnancy
Thyroid dysfunction

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Ischaemic heart disease
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

NSAIDs may provoke or exacerbate asthma
Advise patient ability to drive or operate machinery may be impaired
Consider the need for combination therapy with gastroprotective agents
Exclude blood dyscrasia before treatment in patients with stomatitis
For use only under medical supervision
Preparation contains sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Monitor blood values regularly
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor hepatic function
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
May interfere with thyroid function tests
Discontinue if blood dyscrasia develops
Discontinue if renal function deteriorates
Discontinue if symptoms of hepatic disease occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Reduce dose in elderly
Start treatment at lowest recommended dose
Advise patient that the effects of alcohol may be potentiated
May cause impaired fertility

Use the minimum effective dose for the shortest possible duration.

Blood dyscrasias may occur suddenly after a small dose or insidiously after prolonged therapy particularly in the elderly.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, in the elderly and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

NSAIDs cause dose dependent reduction in prostaglandin formation, can cause oedema and fluid/sodium retention and may precipitate renal failure. Patients at greater risk are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for phenylbutazone.

If phenylbutazone is given for more than one week, liver function tests, kidney function tests and blood counts should be performed periodically. If significant changes occur, the drug should be withdrawn.

Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders may be at increased risk of aseptic meningitis.

Pregnancy and Lactation

Pregnancy

Phenylbutazone is contraindicated during the third trimester of pregnancy but may be used with caution during first and second trimester.

The use of phenylbutazone in the third trimster is contraindicated by the manufacturer and the manufacturer also advises caution if phenylbutazone is used during first and second trimesters.

Available reports indicate that, the use of phenylbutazone during the first and second trimesters should, if possible, be avoided as NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the third trimester, phenylbutazone is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

Lactation

Use Phenylbutazone with caution during breastfeeding.

Manufacturer advises caution and to avoid, if possible, during breastfeeding.

Phenylbutazone has been detected in breast milk in low concentrations.

Side Effects

Abdominal pain
Abnormal liver function
Acute interstitial nephritis
Acute renal failure
Acute tubular necrosis
Aggravation of existing asthma
Agranulocytosis
Allergic reaction
Altered thyroid hormone levels
Anaemia
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Blurred vision
Bone marrow depression
Bronchospasm
Bullous dermatoses
Confusion
Congestive cardiac failure
Depression
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Eosinophilia
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Excitation
Exfoliative dermatitis
Fever
Fulminant hepatitis
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Gastrointestinal disorder
Glomerulonephritis
Goitre
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing loss
Hepatitis
Hypertension
Hypothyroidism
Impaired renal function
Increase in serum transaminases
Intestinal obstruction
Jaundice
Leucopenia
Lymphadenopathy
Malaise
Melaena
Myocarditis
Neck stiffness
Nephrotic syndrome
Nephrotoxicity
Neutropenia
Oedema
Oesophageal stricture
Oesophageal ulceration
Oesophagitis
Optic neuritis
Pancreatitis
Pancytopenia
Papillary necrosis
Paraesthesia
Parotitis
Peptic ulceration
Pericarditis
Peripheral neuropathy
Photosensitivity
Proteinuria
Pruritus
Pulmonary infiltrates
Pulmonary oedema
Purpura
Rash
Retinal haemorrhage
Serum sickness
Sodium/water retention
Stevens-Johnson syndrome
Stomatitis
Systemic lupus erythematosus-like syndrome
Thrombocytopenia
Tinnitus
Ulcerative stomatitis
Ureteric obstruction
Uric acid stones
Urticaria
Vasculitis
Vertigo
Visual disturbances

Presentation

Oral formulation of phenylbutazone.

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis when other therapy is unsuitable

Ankylosing spondylitis

Only to be used by a specialist in severe cases where other treatments have been found unsuitable (risk of serious side effects in particular haematological reactions).

Dosage

Only to be used by a specialist in severe cases where other treatments have been found unsuitable (risk of serious side effects in particular haematological reactions).

The dosage selected should be as low as possible and duration of treatment should be as short as possible.

Adults

Children

Contraindications

Children under 14 years
Haemorrhagic diathesis
Oedema
Asthma, urticaria or acute rhinitis associated with NSAIDS
Haematological disorder
Hereditary fructose intolerance
History of gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
Hypertension
Inflammatory bowel disease
Peptic ulcer
Respiratory impairment
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment
Sjogren's syndrome
Third trimester of pregnancy
Thyroid dysfunction

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Ischaemic heart disease
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

NSAIDs may provoke or exacerbate asthma
Advise patient ability to drive or operate machinery may be impaired
Consider the need for combination therapy with gastroprotective agents
Exclude blood dyscrasia before treatment in patients with stomatitis
For use only under medical supervision
Preparation contains sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Monitor blood values regularly
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor hepatic function
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
May interfere with thyroid function tests
Discontinue if blood dyscrasia develops
Discontinue if renal function deteriorates
Discontinue if symptoms of hepatic disease occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Reduce dose in elderly
Start treatment at lowest recommended dose
Advise patient that the effects of alcohol may be potentiated
May cause impaired fertility

Use the minimum effective dose for the shortest possible duration.

Blood dyscrasias may occur suddenly after a small dose or insidiously after prolonged therapy particularly in the elderly.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, in the elderly and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

NSAIDs cause dose dependent reduction in prostaglandin formation, can cause oedema and fluid/sodium retention and may precipitate renal failure. Patients at greater risk are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for phenylbutazone.

If phenylbutazone is given for more than one week, liver function tests, kidney function tests and blood counts should be performed periodically. If significant changes occur, the drug should be withdrawn.

Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders may be at increased risk of aseptic meningitis.

Pregnancy and Lactation

Pregnancy

Phenylbutazone is contraindicated during the third trimester of pregnancy but may be used with caution during first and second trimester.

The use of phenylbutazone in the third trimster is contraindicated by the manufacturer and the manufacturer also advises caution if phenylbutazone is used during first and second trimesters.

Available reports indicate that, the use of phenylbutazone during the first and second trimesters should, if possible, be avoided as NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the third trimester, phenylbutazone is contraindicated as there is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

Lactation

Use Phenylbutazone with caution during breastfeeding.

Manufacturer advises caution and to avoid, if possible, during breastfeeding.

Phenylbutazone has been detected in breast milk in low concentrations.

Effects on Ability to Drive and Operate Machinery

Drowsiness, dizziness, fatigue and visual disturbances may occur, in which case patients should not drive, operate potentially dangerous machinery, or engage in other activities that may become hazardous because of decreased alertness.

Side Effects

Abdominal pain
Abnormal liver function
Acute interstitial nephritis
Acute renal failure
Acute tubular necrosis
Aggravation of existing asthma
Agranulocytosis
Allergic reaction
Altered thyroid hormone levels
Anaemia
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Blurred vision
Bone marrow depression
Bronchospasm
Bullous dermatoses
Confusion
Congestive cardiac failure
Depression
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Eosinophilia
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Excitation
Exfoliative dermatitis
Fever
Fulminant hepatitis
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Gastrointestinal disorder
Glomerulonephritis
Goitre
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing loss
Hepatitis
Hypertension
Hypothyroidism
Impaired renal function
Increase in serum transaminases
Intestinal obstruction
Jaundice
Leucopenia
Lymphadenopathy
Malaise
Melaena
Myocarditis
Neck stiffness
Nephrotic syndrome
Nephrotoxicity
Neutropenia
Oedema
Oesophageal stricture
Oesophageal ulceration
Oesophagitis
Optic neuritis
Pancreatitis
Pancytopenia
Papillary necrosis
Paraesthesia
Parotitis
Peptic ulceration
Pericarditis
Peripheral neuropathy
Photosensitivity
Proteinuria
Pruritus
Pulmonary infiltrates
Pulmonary oedema
Purpura
Rash
Retinal haemorrhage
Serum sickness
Sodium/water retention
Stevens-Johnson syndrome
Stomatitis
Systemic lupus erythematosus-like syndrome
Thrombocytopenia
Tinnitus
Ulcerative stomatitis
Ureteric obstruction
Uric acid stones
Urticaria
Vasculitis
Vertigo
Visual disturbances

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2021

Reference Sources

Summary of Product Characteristics: Phenylbutazone 100mg tablets. Essential Generics. Revised October 2015.