Ibuprofen | Drugs | BNFC content published by NICE (2024)

With oral use:

Not licensed for use in children aged under 3 months or with body-weight under 5kg.

Maximum dose for systemic juvenile idiopathic arthritis is unlicensed.

With intravenous use

Active bleeding (especially intracranial or gastro-intestinal); coagulation defects (in neonates); ductal-dependent congenital heart disease (in neonates); known or suspected necrotising enterocolitis (in neonates); life-threatening infection (in neonates); marked unconjugated hyperbilirubinaemia (in neonates); pulmonary hypertension (in neonates); thrombocytopenia

With systemic use

Active gastro-intestinal bleeding; active gastro-intestinal ulceration; history of gastro-intestinal bleeding related to previous NSAID therapy; history of gastro-intestinal perforation related to previous NSAID therapy; history of recurrent gastro-intestinal haemorrhage (two or more distinct episodes); history of recurrent gastro-intestinal ulceration (two or more distinct episodes); severe heart failure; varicella infection

With systemic use

Allergic disorders; cardiac impairment (NSAIDs may impair renal function); cerebrovascular disease; coagulation defects; connective-tissue disorders; dehydration (risk of renal impairment); heart failure; history of gastro-intestinal disorders (e.g. ulcerative colitis, Crohn’s disease); ischaemic heart disease; may mask symptoms of infection; peripheral arterial disease; risk factors for cardiovascular events; uncontrolled hypertension

Cautions, further information

High-dose ibuprofen

With oral use:

A small increase in cardiovascular risk, similar to the risk associated with cyclo-oxygenase-2 inhibitors and diclofenac, has been reported with high-dose ibuprofen (≥ 2.4g daily); use should be avoided in patients with established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure (New York Heart Association classification II-III), and uncontrolled hypertension.

Masking of symptoms of underlying infections

With systemic use:

Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsen infection outcome. This has been observed in bacterial community-acquired pneumonia and bacterial complications to varicella. When administered for fever or pain relief in relation to infection, monitoring of infection is advised.

General side-effects:

Common or very common

Constipation; diarrhoea; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; headache; nausea; skin reactions; vomiting

Uncommon

Asthma; hypersensitivity; oedema

Rare or very rare

Agranulocytosis; anaemia; dyspnoea; heart failure; hypertension; leucopenia; meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible); pancytopenia; renal papillary necrosis; respiratory disorders; severe cutaneous adverse reactions (SCARs); shock; thrombocytopenia (very common in neonates)

Frequency not known

Fluid retention (very common in neonates); increased risk of arterial thromboembolism

Specific side-effects:

Common or very common

With intravenous use

Dizziness; fatigue; inflammatory bowel disease; insomnia; intraventricular haemorrhage (in neonates); neutropenia (in neonates); oral disorders; periventricular leukomalacia (in neonates); vertigo

Uncommon

With intravenous use

Anxiety; irritability; nephritis tubulointerstitial; nephrotic syndrome; renal impairment (very common in neonates); tinnitus; vasculitis; vision disorders

With oral use

Rash (discontinue)

Rare or very rare

With intravenous use

Alopecia; auditory disorder; confusion; depression; hepatic disorders; hypotension; infection exacerbated; myocardial infarction; neck stiffness; palpitations; pancreatitis; photosensitivity reaction; psychotic disorder; systemic lupus erythematosus (SLE)

With oral use

Acute kidney injury; angioedema; liver disorder; oral ulceration

Frequency not known

With oral use

Crohn's disease; fertility decreased female; renal failure (more common in patients with pre-existing renal impairment); respiratory tract reaction

Side-effects, further information

For information about cardiovascular and gastrointestinal side-effects, and a possible exacerbation of symptoms in asthma, see Non-steroidal anti-inflammatory drugs

Overdose

Overdosage with ibuprofen may cause nausea, vomiting, epigastric pain, and tinnitus, but more serious toxicity is very uncommon. Charcoal, activated followed by symptomatic measures are indicated if more than 100 mg/kg has been ingested within the preceding hour.

For details on the management of poisoning, see Emergency treatment of poisoning.

With systemic use:

Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment. M

With systemic use:

Avoid use in first and second trimesters unless essential; the MHRA advises additional antenatal monitoring may be required if treatment is considered necessary by a doctor from week 20 of pregnancy onwards.

Avoid use in third trimester.

See NSAIDs in Pregnancy in Non-steroidal anti-inflammatory drugs for further details.

With systemic use for indications relating to Pain or Pyrexia:

Caution in mild to moderate impairment; avoid in severe impairment. M

Dose adjustments

With systemic use for indications relating to Pain or Pyrexia:

The lowest effective dose should be used for the shortest possible duration. M

With systemic use for indications relating to Pain or Pyrexia:

In general, for NSAIDs the MHRA advises to avoid where possible; if necessary, use with caution (risk of fluid retention and further renal impairment, including renal failure).

For ibuprofen, avoid in severe impairment. M

With intravenous use in neonates:

Caution in mild to moderate impairment; avoid if possible in severe impairment. M

Dose adjustments

With systemic use for indications relating to Pain or Pyrexia:

The lowest effective dose should be used for the shortest possible duration. M

With intravenous use:

For intravenous infusion, give over 30 minutes.

With intravenous use in neonates:

For slow intravenous injection, give over 15 minutes, preferably undiluted. May be diluted with Glucose 5% or Sodium Chloride 0.9%.

With oral use:

Flavours of syrup may include orange.

With topical use:

Caution—topical preparations not generally suitable for children.

Medicines for Children leaflet: Ibuprofen for pain and inflammation

https://www.medicinesforchildren.org.uk/medicines/ibuprofen-for-pain-and-inflammation/

Dental practitioners' formulary

With oral use:

Ibuprofen Oral Suspension Sugar-free may be prescribed.

Ibuprofen Tablets may be prescribed.

With oral use:

Oral preparations can be sold to the public in certain circ*mstances.