Home Drug IndexClinical Monograph

Ibuprofen Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Nonsteroidal Anti-inflammatory Drug (NSAID)

Subclass

Propionic Acid Derivative

Speciality

Pain medicine

Schedule (India)

Schedule H (prescription formulations); some low-dose OTC formulations available

Routes

Oral, Intravenous (IV), Topical

Formulations

Tablets: 200 mg, 400 mg, 600 mg, 800 mg
Oral suspension: 100 mg/5 mL, 200 mg/5 mL
Oral drops: 40 mg/mL
Intravenous infusion: 400 mg/100 mL, 800 mg/200 mL
Topical gel/cream: 5%, 10%

Fixed-Dose Combinations (FDCs) Available:

Ibuprofen + Paracetamol (200/325 mg, 400/325 mg, 400/500 mg)
Ibuprofen + Paracetamol + Caffeine
Ibuprofen + Chlorzoxazone (muscle relaxant)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Pain (Musculoskeletal Pain, Dental Pain, Postoperative Pain, Headache)

Parameter	Dose
Starting dose	200–400 mg orally every 6–8 hours as needed
Titration	Increase to 400–600 mg per dose based on pain severity and response
Usual maintenance dose	400–600 mg every 6–8 hours (1200–1800 mg/day)
Maximum dose	2400 mg/day (in divided doses)

Clinical Notes:

Use lowest effective dose for shortest duration
For acute pain, limit to 5–7 days unless strong clinical justification
Take with food or milk to reduce GI irritation
Reassess if pain persists beyond 5 days

2. Fever (Antipyretic Use)

Parameter	Dose
Starting dose	200–400 mg orally every 6–8 hours as needed
Titration	Not applicable for short-term antipyretic use
Usual maintenance dose	200–400 mg every 6–8 hours
Maximum dose	1200 mg/day for antipyretic indication

Clinical Notes:

Paracetamol remains first-line antipyretic in most situations
Reserve ibuprofen for fever unresponsive to paracetamol or when anti-inflammatory effect also needed
Limit to ≤3 days for fever; reassess if fever persists
Avoid in suspected dengue fever (bleeding risk)

3. Primary Dysmenorrhoea

Parameter	Dose
Starting dose	400 mg orally at onset of menstrual pain or cramping
Titration	May increase to 600 mg per dose if 400 mg inadequate
Usual maintenance dose	400 mg every 6 hours
Maximum dose	1200–1600 mg/day

Clinical Notes:

Most effective when started at onset of pain or just before expected menses
NSAIDs are first-line treatment for primary dysmenorrhoea
Continue for 2–3 days as needed per menstrual cycle
If ineffective, consider alternative NSAIDs (mefenamic acid, naproxen) or hormonal therapy

4. Osteoarthritis (Symptomatic Pain and Inflammation)

Parameter	Dose
Starting dose	400 mg orally three times daily with food
Titration	Increase to 600–800 mg three times daily if needed and tolerated
Usual maintenance dose	1200–1800 mg/day in 3–4 divided doses
Maximum dose	2400 mg/day

Clinical Notes:

Use lowest effective dose for shortest duration
For long-term use: reassess periodically; consider gastroprotection
Combine with non-pharmacological measures (physiotherapy, weight management)
If GI risk factors present, co-prescribe PPI (omeprazole, pantoprazole)

5. Rheumatoid Arthritis (Symptomatic Relief)

Parameter	Dose
Starting dose	400–600 mg orally three times daily with food
Titration	May increase to 800 mg three times daily based on symptoms
Usual maintenance dose	1200–2400 mg/day in 3–4 divided doses
Maximum dose	2400 mg/day

Clinical Notes:

NSAIDs provide symptomatic relief only; not disease-modifying
Always use in conjunction with DMARDs (methotrexate, sulfasalazine)
For chronic RA, rheumatology supervision recommended
Monitor for GI, renal, and cardiovascular adverse effects

6. Soft Tissue Injuries, Sprains, Strains

Oral:

Parameter	Dose
Starting dose	400 mg orally every 6–8 hours
Titration	Not applicable for short-term use
Usual maintenance dose	400–600 mg every 6–8 hours
Maximum dose	1800 mg/day

Topical (Gel/Cream):

Apply 5–10% gel to affected area 3–4 times daily
Gently massage into skin
Do not apply to broken skin or wounds
Limit to 2–3 weeks of topical use

Duration: Short-term (5–10 days)

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Supervision	Evidence Basis
Acute Migraine (Mild to Moderate) (OFF-LABEL)	400 mg orally at onset; may repeat after 6 hours if needed; Maximum: 800 mg/day for migraine	Single attack; not for prophylaxis	Not required	Cochrane meta-analysis; Indian neurology practice; effective for mild-moderate attacks
Gout — Acute Flare (OFF-LABEL)	600–800 mg orally three times daily; Maximum: 2400 mg/day	5–7 days until flare resolves	Not required	Indian rheumatology practice; alternative when colchicine contraindicated or not tolerated
Pericarditis — Acute (OFF-LABEL)	600 mg orally three times daily	1–2 weeks; taper over 2–4 weeks	Specialist only (Cardiology)	ESC Guidelines; COPE trial; used in Indian cardiology practice
Patent Ductus Arteriosus (IV — Neonatal) (OFF-LABEL)	IV ibuprofen lysine: 10 mg/kg initial, then 5 mg/kg at 24 and 48 hours	3 doses	Specialist only (Neonatology)	Alternative to indomethacin; used in Indian NICUs

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

⚠️ Not recommended in infants below 3 months of age. Use with caution in infants 3–6 months; paracetamol is preferred in this age group.

Primary Indications: Fever, Mild to Moderate Pain

Weight-Based Oral Dosing (Children ≥3 months, ≥5 kg):

5–7 kg	50 mg	Every 6–8 hours	30 mg/kg/day
8–10 kg	75–100 mg	Every 6–8 hours	30 mg/kg/day
11–15 kg	100–150 mg	Every 6–8 hours	30 mg/kg/day
16–20 kg	150–200 mg	Every 6–8 hours	30 mg/kg/day
21–30 kg	200–300 mg	Every 6–8 hours	30 mg/kg/day
31–40 kg	300–400 mg	Every 6–8 hours	30 mg/kg/day (max 1200 mg)
>40 kg	400 mg	Every 6–8 hours	1200–1800 mg/day

Standard Weight-Based Formula:

Dose: 5–10 mg/kg/dose every 6–8 hours
Maximum: 30–40 mg/kg/day (not to exceed 1200 mg/day in children <12 years)

Parameter	Dose
Starting dose	5–10 mg/kg/dose orally
Titration	Not applicable for short-term use
Usual maintenance dose	5–10 mg/kg every 6–8 hours
Maximum dose	30–40 mg/kg/day OR 1200 mg/day (whichever is lower)

Clinical Notes:

For fever: limit to ≤3 days; reassess if fever persists
For pain: limit to ≤5 days
Do NOT alternate ibuprofen and paracetamol routinely (risk of dosing errors); use only under clear guidance
Ensure adequate hydration
Avoid in children with dehydration, vomiting, or diarrhoea (increased renal risk)
Avoid in suspected dengue fever or varicella (Reye's syndrome-like concerns with NSAIDs in viral illness)

Primary Indication: Juvenile Idiopathic Arthritis (JIA)

Specialist supervision required (Paediatric Rheumatology)

Parameter	Dose
Starting dose	10 mg/kg/dose orally three times daily
Titration	May increase based on response; typical range 30–40 mg/kg/day
Usual maintenance dose	30–40 mg/kg/day in 3–4 divided doses
Maximum dose	40 mg/kg/day OR 2400 mg/day (whichever is lower)

Safety Monitoring:

CBC, renal function, liver function at baseline and every 3–6 months
Monitor for GI symptoms, bleeding, oedema
Ophthalmologic examination (iritis risk in JIA)

Secondary Indications – Paediatrics (Off-label)

Indication	Age	Dose	Duration	Supervision	Evidence Basis
Patent Ductus Arteriosus Closure (Preterm Neonates) (OFF-LABEL)	Preterm neonates	IV Ibuprofen Lysine: 10 mg/kg initial, then 5 mg/kg at 24h and 48h (3 doses total)	3 doses	Specialist only (Neonatology)	Alternative to indomethacin; used in Indian NICUs; similar efficacy with potentially fewer renal effects

Age Restrictions:

Not recommended below 3 months of age for antipyretic/analgesic use
Use in infants 3–6 months only if paracetamol ineffective and under medical supervision
IV ibuprofen for PDA: neonatology specialist only

Renal Adjustments

⚠️ NSAIDs including ibuprofen are nephrotoxic and should be avoided in significant renal impairment.

eGFR (mL/min/1.73 m²)	Recommendation
≥60	No dose adjustment required; use with caution if other risk factors present
30–59	Use with caution; lowest effective dose for shortest duration; avoid chronic use; monitor renal function
<30	Avoid — significant risk of acute kidney injury and fluid retention
Haemodialysis	Avoid — ibuprofen not dialysable; nephrotoxic; may worsen residual renal function
Peritoneal Dialysis	Avoid

Additional Notes:

Risk of AKI increases with dehydration, concurrent ACE inhibitors/ARBs, diuretics, or advanced age
If NSAID essential in moderate CKD, use for shortest duration with renal function monitoring

Hepatic adjustment

Contraindications

Known hypersensitivity to ibuprofen or other NSAIDs
History of NSAID-induced or aspirin-induced asthma, urticaria, or angioedema (aspirin-exacerbated respiratory disease)
Active peptic ulcer disease or gastrointestinal bleeding
History of recurrent peptic ulceration (≥2 episodes)
Severe renal impairment (eGFR <30 mL/min/1.73 m²)
Severe hepatic impairment or active liver disease
Severe heart failure (NYHA Class III–IV)
Third trimester of pregnancy
Concurrent use with other NSAIDs (including COX-2 selective inhibitors)
Perioperative period of coronary artery bypass graft (CABG) surgery
Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with GI bleeding risk
Severe dehydration (risk of acute kidney injury)

Cautions

History of peptic ulcer disease or GI bleeding (healed)
Elderly (≥65 years) — increased GI, renal, and cardiovascular risk
Cardiovascular disease (hypertension, ischaemic heart disease, heart failure, peripheral arterial disease, cerebrovascular disease) — NSAIDs increase CV event risk
Chronic kidney disease (CKD Stage 3)
Mild to moderate hepatic impairment
Asthma (non-aspirin-sensitive) — may rarely precipitate bronchospasm
Coagulation disorders or concurrent anticoagulant therapy
Concurrent use with ACE inhibitors, ARBs, or diuretics — "triple whammy" nephrotoxicity risk
Dehydration or hypovolaemia
Diabetes mellitus (may mask symptoms of hypoglycaemia-induced tachycardia)
Systemic lupus erythematosus (aseptic meningitis risk)
Pre-existing anaemia
History of fluid retention or oedema

Pregnancy

Trimester	Safety	Recommendation
First Trimester	Use with caution	Avoid if possible; some studies suggest slight increased miscarriage risk; use only if clearly needed
Second Trimester	Short-term use may be acceptable	Use lowest effective dose for shortest duration if paracetamol inadequate; obstetric input advised
Third Trimester	Contraindicated	Risk of premature closure of ductus arteriosus; fetal renal impairment; oligohydramnios; prolonged labour; increased maternal bleeding

Parameter	Information
Overall Safety	Avoid throughout pregnancy if possible; paracetamol is preferred
Preferred Alternative	Paracetamol (first-line analgesic/antipyretic in pregnancy)
When Use May Be Justified	Short-term use in 2nd trimester for specific indications (e.g., tocolysis adjunct) under specialist supervision
Monitoring	If used in 2nd trimester: amniotic fluid volume, fetal renal function; avoid after 28–30 weeks

Lactation

Parameter	Information
Compatibility	Compatible with breastfeeding at standard doses
Expected Drug Level in Milk	Very low (<1% of maternal dose reaches infant)
Risk to Infant	Minimal; rare reports of diarrhoea or rash
Preferred Alternatives	Paracetamol (may be preferred for prolonged use)
Infant Monitoring	Routine monitoring not required; observe for GI disturbance, rash
Recommendation	Acceptable for short-term use during breastfeeding

Elderly

Parameter	Recommendation
Starting dose	200 mg orally twice to three times daily (lowest effective dose)
Titration	Increase cautiously; avoid doses >1200 mg/day if possible
Maximum recommended	1200 mg/day (lower than general adult maximum)
Increased Risks	GI bleeding and ulceration (4–5 fold increased risk); acute kidney injury; fluid retention; hypertension; heart failure exacerbation; falls (due to dizziness)
Additional Precautions	Assess GI, renal, and CV risk before prescribing; co-prescribe PPI if NSAID use necessary; use for shortest duration; monitor BP, renal function, and for GI symptoms; avoid chronic use

Major drug interactions

Interacting Drug	Mechanism	Effect	Management
Anticoagulants (warfarin, acenocoumarol, DOACs)	Additive bleeding risk; ibuprofen inhibits platelet function and may displace warfarin from protein binding	Significantly increased GI and other bleeding risk	Avoid combination if possible; if essential, monitor INR closely (warfarin); use lowest NSAID dose for shortest duration; co-prescribe PPI
Low-Dose Aspirin (antiplatelet)	Competitive inhibition at COX-1 binding site	Ibuprofen may antagonise cardioprotective effect of aspirin	Avoid combination if possible; if essential, give aspirin ≥30 minutes before ibuprofen or ≥8 hours after; consider alternative analgesic (paracetamol)
Methotrexate (high-dose)	Reduced renal clearance of methotrexate	Increased methotrexate toxicity (bone marrow suppression, mucositis, hepatotoxicity)	Avoid with high-dose methotrexate; with low-dose MTX, use with caution and monitor
Lithium	Reduced renal lithium excretion	Increased lithium levels and toxicity	Avoid if possible; if essential, monitor lithium levels closely; may need lithium dose reduction
ACE Inhibitors + ARBs + Diuretics ("Triple Whammy")	Haemodynamic effects on renal blood flow	Acute kidney injury, especially in elderly or volume-depleted	Avoid triple combination; if NSAID essential, use lowest dose for shortest duration; monitor renal function
Ciclosporin, Tacrolimus	Additive nephrotoxicity	Increased risk of acute kidney injury	Avoid if possible; if essential, monitor renal function closely

Moderate drug interactions

Interacting Drug	Effect	Management
ACE Inhibitors / ARBs (without diuretic)	Reduced antihypertensive efficacy; increased nephrotoxicity risk	Monitor BP and renal function; use lowest NSAID dose for shortest duration
Diuretics (loop, thiazide)	Reduced diuretic efficacy; increased nephrotoxicity risk	Monitor BP, fluid status, and renal function
Oral Corticosteroids	Additive GI ulceration and bleeding risk	Co-prescribe PPI; use lowest doses; monitor for GI symptoms
Antiplatelets (clopidogrel, ticagrelor)	Additive bleeding risk	Use with caution; monitor for bleeding; co-prescribe PPI
SSRIs / SNRIs	Additive GI bleeding risk	Co-prescribe PPI if combination necessary; monitor for bleeding
Sulfonylureas (glibenclamide, glimepiride)	Possible enhanced hypoglycaemic effect	Monitor blood glucose
Antihypertensives (beta-blockers, CCBs)	NSAIDs may reduce antihypertensive efficacy	Monitor BP; adjust antihypertensive dose if needed
Aminoglycosides	Reduced renal clearance of aminoglycosides	Monitor aminoglycoside levels and renal function
Quinolone Antibiotics (ciprofloxacin, levofloxacin)	Possible increased seizure risk (rare)	Use with caution in patients with seizure history
Phenytoin	Possible increased phenytoin levels	Monitor phenytoin levels if concurrent use
Digoxin	Possible increased digoxin levels	Monitor digoxin levels in patients on concurrent therapy

Common Adverse effects

Dyspepsia, heartburn, epigastric pain (10–15%)
Nausea, vomiting
Diarrhoea, constipation
Abdominal discomfort, bloating
Headache
Dizziness
Rash (mild)
Fluid retention, peripheral oedema
Elevated blood pressure
Tinnitus (dose-related)

Serious Adverse effects

Adverse Effect	Clinical Action
GI Ulceration, Perforation, or Haemorrhage (may occur without warning; higher risk in elderly, those with prior ulcer, or on anticoagulants)	Discontinue immediately; urgent GI evaluation; may require endoscopy, transfusion, or surgery
Acute Kidney Injury (especially in dehydration, CKD, or concurrent nephrotoxic drugs)	Discontinue immediately; IV fluids; monitor renal function; avoid rechallenge
Cardiovascular Events (MI, stroke — increased risk with high doses or prolonged use)	Use lowest effective dose for shortest duration; contraindicated in severe heart failure
Severe Hypersensitivity / Anaphylaxis	Discontinue permanently; emergency management
NSAID-Induced Asthma / Bronchospasm (aspirin-exacerbated respiratory disease)	Discontinue permanently; bronchodilator therapy; avoid all NSAIDs
Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) (very rare)	Discontinue immediately; hospitalisation; dermatology consultation
Hepatotoxicity (elevated transaminases, cholestatic hepatitis — rare)	Monitor LFTs if symptoms; discontinue if significant elevation
Aseptic Meningitis (rare; especially in SLE patients)	Discontinue; CSF analysis; usually resolves after discontinuation
Agranulocytosis / Aplastic Anaemia (very rare)	Discontinue; haematology referral
Heart Failure Exacerbation (fluid retention)	Discontinue; manage HF; avoid NSAIDs in future

Monitoring requirements

Timing	Parameters
Baseline (if prolonged use planned)	BP; renal function (serum creatinine, eGFR); hepatic function (LFTs); CBC; assessment of GI, CV, and renal risk factors
Short-term use (<7 days)	No routine monitoring required in healthy adults; assess for GI symptoms
After initiation of chronic use (2–4 weeks)	Renal function; BP; assess for GI symptoms, oedema, bleeding
Long-term/Chronic use	Renal function every 3–6 months; periodic LFTs; BP monitoring; GI symptom assessment at each visit; CBC if symptoms suggest anaemia
High-risk patients (elderly, CKD, CV disease)	More frequent monitoring; consider gastroprotection with PPI

Brands in India

Monotherapy:

Brufen™ (Abbott) — 200 mg, 400 mg, 600 mg tablets; suspension
Ibugesic™ (Cipla) — 200 mg, 400 mg tablets; suspension; drops
Icparil™ — 200 mg, 400 mg tablets
Ibuprofen™ (Various generics)

Paediatric Formulations:

Ibugesic™ Suspension — 100 mg/5 mL
Brufen™ Suspension — 100 mg/5 mL
Ibugesic™ Drops — 40 mg/mL

Intravenous:

Brufen IV™ — 400 mg/100 mL, 800 mg/200 mL

Topical:

Brufen™ Gel — 5%
Ibugesic™ Gel — 5%

Fixed-Dose Combinations (Examples):

Combiflam™ (Sanofi) — Ibuprofen 400 mg + Paracetamol 325 mg
Ibugesic Plus™ — Ibuprofen + Paracetamol (various strengths)
Ibuclin™ — Ibuprofen + Paracetamol

⚠️ Note on FDCs: When using ibuprofen-paracetamol combinations, ensure total paracetamol dose from all sources does not exceed 4 g/day.

Price range (INR)

200 mg tablet	₹0.50–₹2.00 per tablet	—
400 mg tablet	₹1.00–₹3.50 per tablet	NLEM listed
600 mg tablet	₹2.00–₹5.00 per tablet	—
Oral suspension (100 mL)	₹25–₹60	—
Oral drops (15 mL)	₹25–₹45	—
IV infusion (400 mg/100 mL)	₹80–₹180 per vial	—
Topical gel (30 g)	₹40–₹80	—
Ibuprofen + Paracetamol FDC	₹2–₹6 per tablet	—

Regulatory: Listed under NLEM 2022 (400 mg tablet, 100 mg/5 mL suspension); NPPA price controlled for scheduled strengths; available in government supply

Clinical pearls

GI protection in high-risk patients — Co-prescribe PPI (omeprazole 20 mg, pantoprazole 40 mg) in patients ≥65 years, those with history of peptic ulcer, or concurrent corticosteroid/anticoagulant use; gastroprotection reduces but does not eliminate GI risk
Aspirin interaction matters — Ibuprofen given before low-dose aspirin can block aspirin's antiplatelet effect; if both needed, give aspirin ≥30 minutes before ibuprofen or use alternative analgesic (paracetamol)
Avoid in dengue fever — NSAIDs including ibuprofen are contraindicated in suspected dengue due to increased bleeding risk; paracetamol is the only recommended antipyretic/analgesic in dengue
Shortest duration principle — Use lowest effective dose for shortest possible duration; chronic NSAID use significantly increases GI, renal, and CV adverse event risk
Third trimester is absolute contraindication — Never prescribe ibuprofen after 28–30 weeks gestation; risk of premature ductus arteriosus closure and fetal renal toxicity
Triple whammy nephrotoxicity — Avoid combining ibuprofen with ACE inhibitor/ARB + diuretic especially in elderly or those with CKD; this combination significantly increases AKI risk

Version

RxIndia v1.0 — 07 May 2024

Reference

CDSCO Product Information
Indian Pharmacopoeia (IP)
National List of Essential Medicines (NLEM) 2022
API Textbook of Medicine
AIIMS Drug Formulary and Treatment Protocols
ICMR Pain Management Recommendations
IAP Guidelines for Fever Management in Children
Harrison's Principles of Internal Medicine
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Cochrane Reviews on Ibuprofen for Acute Pain and Migraine
Indian Rheumatology Association Guidelines (JIA)
MoHFW Paediatric Dosing Guidelines

⚖️

Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

Content Feedback

Is this information helpful?

Help us improve our clinical database for the medical community.

RxIndia

Loading clinical data...