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← New search | Ibuprofen/Paracetamol

INN monograph

Ibuprofen/Paracetamol

Nonsteroidal Anti-inflammatory Drug [EPC] · POM

POM Source-linked Grade A

Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)

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Risk first

Contraindications

  • [Ibuprofen] Active peptic ulcer / GI bleeding.
  • Severe heart failure.
  • NSAID-exacerbated respiratory disease (aspirin-sensitive asthma) for non-selective agents.
  • Third trimester pregnancy (ductus arteriosus, oligohydramnios — class warning).
  • Severe renal impairment for many agents.
  • Hypersensitivity to NSAIDs. [Paracetamol] Severe active hepatic disease / acute liver failure.
  • Hypersensitivity.
  • Chronic heavy alcohol use — use reduced maximum daily dose or avoid.

Precautions

  • Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
  • Symptoms may include: rash facial swelling asthma (wheezing) hives skin reddening shock blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
  • The chance is higher if you: take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
  • These can be fatal.
  • The risk is higher if you use more than directed or for longer than directed.
  • Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain slurred speech trouble breathing leg swelling weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.
  • It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Point of care

Dosing

Adult

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Paediatric

See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.

Renal

Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.

  • CrCl 0–120: Confirm renal dosing in product SmPC / primary label.

Hepatic

PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.

Safety

Drug interactions

Open checker →
  • Fixed-dose/multi-ingredient product.
  • Clinical details partially inherited from component monographs: Ibuprofen, Paracetamol.
  • Confirm combination SmPC for exact dosing.

Safety

Adverse effects

  • [Ibuprofen] Dyspepsia, nausea, fluid retention, raised BP.
  • Serious: peptic ulcer/bleed, AKI, heart failure exacerbation, severe skin reactions, bronchospasm, hepatitis (rare). [Paracetamol] Rare at therapeutic doses.
  • Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP).

Use

Indications

  • Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever Clinical selection for Ibuprofen/Paracetamol should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
  • Class context: Nonsteroidal Anti-inflammatory Drug [EPC].
  • Confirm site-specific dose, duration and monitoring before prescribing.

Pharmacology

Mode of action

Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2.

Inhibit COX ↓ Prostaglandins Analgesia / anti-inflammatory
Full mechanism text

Inhibitors of cyclo-oxygenase [COX-1 and COX-2] enzyme that catalyzes the conversion of arachidonic acid to PGH2. Paracetamol inhibits central prostaglandin synthesis via effects on cyclo-oxygenase pathways (including COX-2 preferential central effects) and may engage serotonergic descending pathways. Antipyretic effect via hypothalamic heat-regulating centre. Minimal peripheral anti-inflammatory action.

ADME

Pharmacokinetics & PD

Onset 30–60 minutes oral
Duration 4–6 hours
Route ORAL / RECTAL / IV
Metabolism (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted.
Half-life ~2–3 h; prolonged in liver disease/overdose.
Full PK/PD text

Rapid oral absorption. Hepatic metabolism (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. Half-life ~2–3 h; prolonged in liver disease/overdose.

Kenya

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Special populations

Pregnancy & lactation

Pregnancy

[Ibuprofen] Avoid in third trimester. Earlier pregnancy: use only if needed; prefer paracetamol first-line. [Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.

Lactation

Compatible with breastfeeding at standard doses.

Diet

Food & alcohol

  • Food
  • Food

Trust

Sources & disclaimer

Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)

Open source link

Clinical review date not recorded.

Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.

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