Diclofenac Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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Therapeutic Class
Non-steroidal Anti-inflammatory Drug (NSAID)
Subclass
Arylacetic acid derivative
Speciality
Pain Medicine
Schedule (India)
Schedule H
Routes
Oral, Parenteral (IM, IV), Topical (gel, patch, solution), Rectal, Ophthalmic
Formulations
| Form | Strengths Available |
|---|---|
| Tablet (immediate-release) | 25 mg, 50 mg |
| Tablet (sustained-release) | 75 mg, 100 mg |
| Injection (IM) | 75 mg/3 mL |
| Injection (IV) | 75 mg/1 mL |
| Topical gel | 1%, 2% |
| Transdermal patch | 100 mg |
| Eye drops | 0.1% |
| Suppository | 50 mg, 100 mg |
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Osteoarthritis, Musculoskeletal Pain, Low Back Pain
| Parameter | Oral (Immediate-Release) | Oral (Sustained-Release) |
|---|---|---|
| Starting dose | 50 mg twice daily | 75 mg once daily |
| Titration | Increase by 25–50 mg/day based on response and tolerability | May increase to twice daily if inadequate response |
| Usual maintenance dose | 100–150 mg/day in 2–3 divided doses | 75–100 mg once or twice daily |
| Maximum dose | 150 mg/day (200 mg/day short-term only, ≤14 days) | 200 mg/day (short-term only) |
Clinical Notes: Use lowest effective dose for shortest duration. Co-prescribe PPI if risk factors for GI bleeding present.
2. Rheumatoid Arthritis, Ankylosing Spondylitis
| Parameter | Dosing |
|---|---|
| Starting dose | 50 mg twice or thrice daily OR 75 mg SR twice daily |
| Titration | Adjust based on disease activity and tolerance |
| Usual maintenance dose | 100–150 mg/day in divided doses |
| Maximum dose | 200 mg/day (short periods during flares only, ≤7 days) |
Clinical Notes: Often used as adjunct to DMARDs. Regular monitoring of LFTs and renal function essential with long-term use.
3. Acute Migraine
| Parameter | Dosing |
|---|---|
| Starting dose | 50–75 mg orally at onset |
| Titration | Not applicable |
| Usual maintenance dose | Single dose at onset; may repeat once after 8 hours |
| Maximum dose | 150 mg/day |
| Alternative routes | Rectal: 50–100 mg suppository; IM: 75 mg once (if vomiting present) |
Clinical Notes: Most effective when administered early in attack. Specialist supervision recommended for frequent use.
4. Acute Post-operative Pain, Renal Colic
| Route | Dosing Details |
|---|---|
|
IM Injection
|
Starting dose: 75 mg stat |
| Titration: May repeat after 6–8 hours if required | |
| Maximum dose: 150 mg/day | |
| Maximum duration: 2 days | |
|
IV Infusion
|
Dilute 75 mg in 100–500 mL NS or 5% dextrose |
| Infuse over 30–120 minutes | |
| Maximum duration: 2 days, then switch to oral |
Clinical Notes: Avoid IM route in anticoagulated patients. IV route preferred in hospital settings with monitoring.
5. Localized Soft Tissue Inflammation (Sprain, Tendinitis, Sports Injuries)
| Parameter | Topical Gel/Solution |
|---|---|
| Starting dose | Apply 2–4 g to affected area |
| Frequency | 3–4 times daily |
| Maximum dose | 8 g per joint per day; 32 g total body per day |
| Duration | Up to 14 days for acute conditions |
Clinical Notes: Systemic absorption is minimal. Preferred route for localized knee/hand osteoarthritis in elderly.
Secondary Indications — Adults Only (Off-label)
| Indication | Dose | Duration | Supervision | Evidence |
|---|---|---|---|---|
| Renal colic (adjunct to hydration/antispasmodics) | 75 mg IM once; repeat after 6 hours if needed | ≤3 days | ER physician | Supported by RCTs; AIIMS ER protocols |
| Dysmenorrhoea (primary) | 50 mg thrice daily or 75 mg SR twice daily | During menstruation only | General practice | Indian specialist practice; standard obstetric texts |
| Acute gout flare (if colchicine contraindicated) | 50 mg thrice daily | 5–7 days | Specialist only | OFF-LABEL; API Textbook supportive |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Juvenile Idiopathic Arthritis (JIA) — Paediatric Rheumatologist Only
| Parameter | Dosing |
|---|---|
| Age limit | ≥14 years only |
| Starting dose | 1 mg/kg/day in 2–3 divided doses |
| Titration | Increase based on response; maximum 2 mg/kg/day |
| Usual maintenance dose | 1–2 mg/kg/day in divided doses |
| Maximum dose | 150 mg/day (regardless of weight) |
Safety Monitoring:
- Baseline and periodic LFTs (every 4–6 weeks initially)
- Monitor for GI symptoms (epigastric pain, black stools)
- Avoid sustained-release preparations
- Ensure adequate hydration
Secondary Indications — Paediatric Doses (Off-label)
| Indication | Dose | Age | Supervision | Evidence |
|---|---|---|---|---|
| Post-operative analgesia (short-term) | 0.5–1 mg/kg/dose twice daily | ≥14 years | Specialist only | OFF-LABEL; limited paediatric surgery data |
Not recommended for:
- Migraine prophylaxis in children
- General pain relief in children <14 years
- Fever management
⚠️ CLEAR STATEMENT: Diclofenac is NOT recommended in children <14 years except under paediatric rheumatology or specialist supervision. First-line alternatives: Paracetamol, Ibuprofen (for children ≥3 months).
Renal Adjustments
| eGFR (mL/min/1.73 m²) | Recommendation |
|---|---|
| >60 | No adjustment; use standard dosing |
| 30–60 | Use with caution; start at lower dose; monitor creatinine weekly |
| <30 |
AVOID — increased risk of acute kidney injury and fluid retention
|
| Haemodialysis |
Not dialysed significantly; AVOID due to residual renal function risk
|
| Peritoneal dialysis |
AVOID
|
Monitoring: Serum creatinine, urea, and electrolytes at baseline and periodically (every 2–4 weeks if used in mild-moderate impairment).
Hepatic adjustment
Contraindications
- Known hypersensitivity to diclofenac or any excipient
- History of asthma, urticaria, angioedema, or allergic reactions precipitated by aspirin or other NSAIDs
- Active peptic ulcer disease or gastrointestinal bleeding
- History of GI bleeding or perforation related to prior NSAID therapy
- Severe hepatic impairment (Child-Pugh C)
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Severe heart failure (NYHA Class III–IV)
- Established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease
- Perioperative pain management in coronary artery bypass graft (CABG) surgery
- Third trimester of pregnancy
- Active inflammatory bowel disease (ulcerative colitis, Crohn's disease)
Cautions
- Elderly patients (increased GI, renal, and cardiovascular risk)
- Mild-to-moderate hypertension (may worsen blood pressure control)
- Compensated heart failure (NYHA Class I–II)
- History of peptic ulcer disease (healed)
- Concurrent anticoagulant or antiplatelet therapy
- NSAID-exacerbated respiratory disease (aspirin-sensitive asthma)
- Volume depletion or dehydration
- Concurrent use of nephrotoxic drugs
- Systemic lupus erythematosus (SLE) or mixed connective tissue disease
- Long-term use: requires regular monitoring of renal, hepatic function, and CBC
- Smokers and alcohol users (increased GI bleeding risk)
Pregnancy
| Aspect | Details |
|---|---|
| Risk Category |
First/Second Trimester: Category C equivalent; Third Trimester: CONTRAINDICATED
|
| First Trimester | Avoid if possible; potential association with miscarriage (conflicting data) |
| Second Trimester | Use only if clearly necessary; short-term use; lowest effective dose |
| Third Trimester |
CONTRAINDICATED — risk of premature closure of ductus arteriosus, oligohydramnios, delayed labour
|
| Preferred Alternatives | Paracetamol (first-line for pain/fever throughout pregnancy) |
| Monitoring | If use unavoidable in second trimester: monitor amniotic fluid volume via ultrasound; fetal echocardiography if prolonged use |
Lactation
| Aspect | Details |
|---|---|
| Compatibility | Compatible with breastfeeding for short-term use |
| Levels in breast milk | Low (milk:plasma ratio ~0.01–0.1) |
| Duration limit | Avoid oral use beyond 3 days; topical preferred for local pain |
| Infant monitoring | Observe for GI upset (vomiting, diarrhoea), reduced feeding, irritability |
| Preferred alternatives | Paracetamol, Ibuprofen (both well-established in lactation) |
Elderly
| Aspect | Recommendation |
|---|---|
| Starting dose | 25–50 mg/day (lowest effective dose) |
| Titration | Slow titration over 1–2 weeks based on response |
| Maximum dose | Aim for ≤100 mg/day |
| Duration | Shortest duration possible |
| Special risks | Increased GI bleeding (4-fold higher), renal impairment, cardiovascular events, confusion, fluid retention |
| Co-prescription | PPI (e.g., Pantoprazole 40 mg daily) strongly recommended for gastroprotection |
| Preferred alternatives | Topical diclofenac for localized OA; Paracetamol for mild pain |
Major drug interactions
| Interacting Drug | Effect | Management |
|---|---|---|
| Warfarin, Acenocoumarol | Increased bleeding risk; enhanced anticoagulant effect |
Avoid combination OR monitor INR closely; consider PPI co-prescription
|
| Apixaban, Rivaroxaban, Dabigatran | Increased bleeding risk |
Avoid combination if possible
|
| Aspirin (antiplatelet doses) | Additive GI toxicity; may reduce cardioprotective effect of aspirin |
Avoid combination; if essential, use lowest NSAID dose + PPI
|
| Methotrexate (high-dose) | Decreased methotrexate clearance → toxicity |
Avoid within 24 hours of high-dose MTX
|
| Lithium | Increased serum lithium levels (20–40%) → toxicity | Monitor lithium levels; reduce lithium dose if needed |
| Other NSAIDs | Additive GI and renal toxicity; no additional efficacy |
Avoid combination
|
| Pemetrexed | Decreased renal clearance → increased toxicity |
Avoid for 2 days before to 2 days after pemetrexed
|
Moderate drug interactions
| Interacting Drug | Effect | Management |
|---|---|---|
| ACE inhibitors (Enalapril, Ramipril) | Reduced antihypertensive effect; increased nephrotoxicity risk | Monitor BP and renal function; ensure hydration |
| ARBs (Losartan, Telmisartan) | Same as ACE inhibitors | Monitor BP and renal function |
| Loop diuretics (Furosemide) | Reduced diuretic efficacy; increased nephrotoxicity | Monitor fluid status, urine output, renal function |
| Thiazides (Hydrochlorothiazide) | Reduced antihypertensive and diuretic effect | Monitor BP |
| SSRIs (Fluoxetine, Sertraline) | Increased GI bleeding risk | Co-prescribe PPI |
| Corticosteroids | Increased GI ulceration and bleeding risk | Co-prescribe PPI; limit duration |
| Cyclosporine | Additive nephrotoxicity | Monitor renal function closely |
| Tacrolimus | Additive nephrotoxicity | Monitor renal function closely |
| Methotrexate (low-dose) | Mild increase in MTX levels | Monitor for MTX toxicity; check CBC |
| Quinolones (Ciprofloxacin, Levofloxacin) | Rare increased seizure risk | Use with caution in epilepsy |
| Digoxin | Increased digoxin levels | Monitor digoxin levels if initiating/stopping diclofenac |
Common Adverse effects
- Dyspepsia, epigastric discomfort (10–30%)
- Nausea, vomiting (3–10%)
- Diarrhoea or constipation (1–10%)
- Headache (3–9%)
- Dizziness (1–3%)
- Peripheral oedema, fluid retention (1–3%)
- Elevated transaminases (up to 15%, usually transient)
- Application site reactions with topical use (pruritus, erythema, dermatitis)
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
| Peptic ulcer, GI bleeding, perforation | May occur without warning; higher risk in elderly, prior ulcer history |
| Acute kidney injury | Especially with dehydration, concurrent nephrotoxins, or pre-existing renal impairment |
| Hepatotoxicity | Monitor LFTs; discontinue if ALT >3× ULN with symptoms |
| Cardiovascular thrombotic events | MI, stroke — risk increases with dose and duration |
| Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN) | Rare; discontinue immediately if mucocutaneous lesions appear |
| Anaphylaxis, angioedema | Immediate discontinuation; emergency management |
| NSAID-exacerbated respiratory disease | Bronchospasm in aspirin-sensitive asthmatics |
| Agranulocytosis, aplastic anaemia | Rare; discontinue and refer to haematology |
| Aseptic meningitis | Rare; reported in SLE patients |
Monitoring requirements
| Phase | Parameters |
|---|---|
|
Baseline
|
CBC, LFTs (ALT, AST), renal function (creatinine, urea, eGFR), blood pressure |
|
After 1–2 weeks
|
Renal function, LFTs (especially if prolonged use anticipated) |
|
Monthly (if long-term)
|
Renal function, LFTs |
|
Every 2–3 months (chronic use)
|
CBC, LFTs, renal function |
|
Ongoing
|
GI symptoms (dyspepsia, melaena, haematemesis); blood pressure if hypertensive; signs of fluid retention |
Brands in India
| Brand Name | Manufacturer | Notes |
|---|---|---|
| Voveran | Novartis | Tablets, SR, injection, gel |
| Voveran SR | Novartis | Sustained-release formulation |
| Diclogem | Gemini | Tablets, gel |
| Dicloran | Ipca | Tablets, injection |
| Dynapar | Troikaa | Tablets, gel, injection |
| Reactin | Alkem | Tablets, SR |
| Voltaren | GSK (Originator) | Limited availability |
| Jonac | Cadila | Tablets, gel |
Note: Multiple fixed-dose combinations (FDCs) with paracetamol, serratiopeptidase exist — evaluate rationality and necessity before prescribing. Many FDCs banned by CDSCO.
Price range (INR)
| Formulation | Price Range | NLEM Status |
|---|---|---|
| Tablet 50 mg | ₹1–₹3 per tablet | ✓ Included in NLEM 2022 |
| SR Tablet 100 mg | ₹2–₹6 per tablet | ✓ Included in NLEM 2022 |
| Injection 75 mg/3 mL | ₹5–₹20 per ampoule | ✓ Included in NLEM 2022 |
| Topical gel 1% (30 g) | ₹40–₹80 per tube | ✓ Price regulated |
| Eye drops 0.1% (5 mL) | ₹30–₹60 | — |
| Suppository 50 mg | ₹15–₹30 per unit | — |
Note: Prices regulated by NPPA under Drug Price Control Order for NLEM formulations. Government supply available at subsidised rates.
Clinical pearls
- Gastroprotection is essential: Co-prescribe PPI (Pantoprazole/Omeprazole) for patients aged >65 years, those with ulcer history, or on concurrent anticoagulants/corticosteroids/SSRIs.
- Topical route reduces systemic risk: For localized knee or hand osteoarthritis, topical diclofenac achieves adequate local effect with minimal systemic exposure — preferred in elderly or those with cardiovascular/renal concerns.
- Renal colic efficacy: IM diclofenac 75 mg provides rapid, effective analgesia for renal colic and is equivalent to opioids in many RCTs — first-line in AIIMS ER protocols.
- Avoid IM in anticoagulated patients: Risk of intramuscular haematoma; use IV infusion or oral/rectal alternatives.
- Shortest duration principle: Cardiovascular risk increases with dose and duration — use lowest effective dose for shortest period necessary.
- Third trimester is absolute contraindication: Risk of premature ductus arteriosus closure — no exceptions; switch to paracetamol.
- Transaminase elevations common but often transient: Monitor LFTs; discontinue only if ALT >3× ULN with symptoms or ALT >5× ULN without symptoms.
Version
RxIndia v1.1 — 28 Mar 2025
Reference
-
- CDSCO approved prescribing information
- Indian Pharmacopoeia 2022
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine (11th Edition)
- AIIMS Drug Formulary
- AIIMS Emergency Department protocols (renal colic management)
- ICMR Guidelines on rational use of analgesics
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)
- Harrison's Principles of Internal Medicine (supportive)
- International RCTs for renal colic efficacy (off-label evidence)
⚖️
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.
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