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Paracetamol Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Analgesic and Antipyretic

Subclass

Non-opioid Analgesic (Para-aminophenol Derivative)

Speciality

Pain medicine

Schedule (India)

Non-scheduled (monotherapy in standard strengths) / Schedule H (in certain combinations)

Routes

Oral, Intravenous (IV), Rectal

Formulations

Tablets: 325 mg, 500 mg, 650 mg, 1000 mg
Dispersible/Soluble tablets: 125 mg, 250 mg, 500 mg
Oral suspension/Syrup: 120 mg/5 mL, 125 mg/5 mL, 250 mg/5 mL
Paediatric drops: 100 mg/mL, 150 mg/mL
Intravenous infusion: 10 mg/mL (100 mL vial = 1000 mg)
Suppositories (Paediatric): 80 mg, 125 mg, 170 mg, 250 mg, 500 mg

Adult indications

NDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Fever (Antipyretic)

Adults — Oral:

Parameter	Dose
Starting dose	500–1000 mg orally
Titration	Not applicable
Usual maintenance dose	500–1000 mg every 4–6 hours as needed
Maximum dose	4000 mg/day (3000 mg/day in patients with hepatic risk factors)

Clinical Notes:

Maintain minimum 4-hour interval between doses
Use lowest effective dose for shortest duration
Efficacy for fever reduction similar to ibuprofen; onset within 30–60 minutes
Duration of antipyretic effect: 4–6 hours

2. Mild to Moderate Pain (Headache, Musculoskeletal Pain, Dental Pain, Dysmenorrhoea)

Adults — Oral:

Parameter	Dose
Starting dose	500–1000 mg orally
Titration	Not applicable for acute use
Usual maintenance dose	500–1000 mg every 4–6 hours as needed
Maximum dose	4000 mg/day

Clinical Notes:

First-line analgesic for mild to moderate pain
Preferred over NSAIDs in patients with GI, renal, or cardiovascular risk factors
May be combined with weak opioids (codeine, tramadol) for moderate pain — calculate total paracetamol from all sources

3. Postoperative Pain (Intravenous — Hospital Setting)

Adults — Intravenous:

Parameter	Dose
Starting dose	1000 mg IV infusion over 15 minutes
Titration	Not applicable
Usual maintenance dose	1000 mg IV every 4–6 hours
Maximum dose	4000 mg/day

For Adults <50 kg Body Weight:

Parameter	Dose
Starting dose	15 mg/kg IV (maximum 750 mg per dose)
Usual maintenance dose	15 mg/kg every 4–6 hours
Maximum dose	60 mg/kg/day (maximum 3000 mg/day)

Clinical Notes:

Use as part of multimodal analgesia to reduce opioid requirements
IV route provides faster onset (5–10 minutes) compared to oral
Reserve IV for patients unable to take oral medications
Switch to oral formulation as soon as clinically feasible (cost consideration)

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Supervision	Evidence Basis
Osteoarthritis — Mild Pain (OFF-LABEL)	500–1000 mg orally three to four times daily; Maximum: 3000–4000 mg/day	Long-term as needed	Not required	Indian rheumatology practice; EULAR/ACR guidelines recommend as first-line before NSAIDs; limited efficacy in moderate-severe OA pain
Migraine — Acute Treatment (Adjunct) (OFF-LABEL)	1000 mg orally at onset; may combine with caffeine or antiemetic; Maximum: single dose or repeat after 4–6 hours	Single attack; avoid chronic daily use	Not required	Indian Headache Society recommendations; RCTs show efficacy for mild-moderate migraine
Tension-type Headache (OFF-LABEL)	500–1000 mg orally at onset	As needed; limit to <15 days/month	Not required	Cochrane review; first-line for episodic TTH

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Paracetamol is the preferred antipyretic and analgesic in children. Weight-based dosing is essential to avoid under- or overdosing.

Primary Indications: Fever and Mild to Moderate Pain

Oral Dosing (Syrup/Drops/Dispersible Tablets):

Preterm neonates (<32 weeks)	10–12 mg/kg	Every 8–12 hours	30 mg/kg/day
Term neonates (0–28 days)	10–15 mg/kg	Every 6–8 hours	60 mg/kg/day
1–3 months	10–15 mg/kg	Every 6–8 hours	60 mg/kg/day
3–12 months	10–15 mg/kg	Every 4–6 hours	60 mg/kg/day
1–5 years	10–15 mg/kg	Every 4–6 hours	60 mg/kg/day (up to 75 mg/kg/day for short-term use under supervision)
6–12 years	10–15 mg/kg	Every 4–6 hours	60 mg/kg/day or 4000 mg/day (whichever is lower)
>12 years	500–1000 mg	Every 4–6 hours	4000 mg/day

Rectal Dosing (Suppositories):

Age	Dose	Frequency	Notes
3 months–1 year	60–125 mg	Every 6–8 hours	Use when oral route not feasible
1–5 years	125–250 mg	Every 4–6 hours	—
6–12 years	250–500 mg	Every 4–6 hours	—

Intravenous Dosing (Hospital Setting Only):

Weight/Age	Dose	Frequency	Maximum Daily Dose
Preterm neonates (≥32 weeks)	7.5 mg/kg	Every 8 hours	22.5 mg/kg/day
Term neonates to <10 kg	7.5 mg/kg	Every 4–6 hours	30 mg/kg/day
≥10 kg to <33 kg	15 mg/kg	Every 4–6 hours	60 mg/kg/day
33–50 kg	15 mg/kg	Every 4–6 hours	60 mg/kg/day (max 3000 mg/day)
>50 kg	1000 mg	Every 4–6 hours	4000 mg/day

Safety Monitoring:

Always calculate dose based on actual body weight
Ensure caregivers understand correct measuring technique for liquid formulations
Calculate total paracetamol intake from all sources (including combination products)
Monitor for hepatotoxicity signs if used for >3 days continuously

Clinical Notes:

For infants <2 months with fever: specialist evaluation recommended before treatment (rule out serious bacterial infection)
Paracetamol preferred over ibuprofen in children <6 months, those with dehydration, varicella, or dengue
Alternating paracetamol and ibuprofen is not routinely recommended (risk of dosing errors)

Secondary Indications – Paediatrics (Off-label)

Indication	Age	Dose	Duration	Supervision	Evidence Basis
Patent Ductus Arteriosus (PDA) Closure in Preterm Neonates (OFF-LABEL)	Preterm neonates	15 mg/kg orally or IV every 6 hours	3–7 days	Specialist only (Neonatologist)	Multiple RCTs (Hammerman et al., Ohlsson et al.); Indian NICU protocols; alternative when indomethacin/ibuprofen contraindicated or unavailable

Age Restrictions:

Infants <2 months: Use with caution; specialist evaluation recommended for underlying cause of fever
Preterm neonates: Use only under neonatology supervision with appropriate dose adjustments

Renal Adjustments

eGFR (mL/min/1.73 m²)	Recommendation
≥50	No dose adjustment required
10–50	No dose adjustment required; use standard doses
<10	Extend dosing interval to every 6–8 hours; maximum 3000 mg/day
Haemodialysis	Paracetamol is dialysable; dose post-dialysis if timing coincides; no supplemental dose usually required
Peritoneal Dialysis	Use with caution; extend dosing interval

Note: Paracetamol metabolites may accumulate in severe renal impairment; prefer oral over IV if possible.

Hepatic adjustment

Contraindications

Known hypersensitivity to paracetamol or any excipients
Severe hepatic impairment or active hepatic disease
Acute hepatic failure

Cautions

Chronic alcohol consumption (≥3 alcoholic drinks/day) — increased hepatotoxicity risk
Malnutrition, anorexia nervosa, or prolonged fasting — depleted glutathione stores
Chronic liver disease (mild to moderate)
Severe renal impairment
Glucose-6-phosphate dehydrogenase (G6PD) deficiency (rare haemolysis reported at very high doses)
Low body weight (<50 kg in adults) — adjust dosing accordingly
Concurrent use with other paracetamol-containing products (FDCs, OTC cold/flu medicines) — risk of inadvertent overdose
Prolonged use (>10 days without medical supervision)
Dehydration
Concurrent hepatotoxic medications (isoniazid, rifampicin, phenytoin, carbamazepine)

Pregnancy

Parameter	Information
Overall Safety	Considered safe in all trimesters; most widely used analgesic and antipyretic in pregnancy
Risk	No confirmed teratogenic effects at therapeutic doses; some observational studies suggest possible association with ADHD/autism with prolonged high-dose use (unconfirmed, likely confounded)
Preferred Alternatives	None — paracetamol is first-line for fever and mild-moderate pain in pregnancy
When to Use	Use at lowest effective dose for shortest duration; avoid chronic daily use if possible
Monitoring	Liver function in patients with pre-eclampsia, HELLP syndrome, or other hepatic conditions

Lactation

Parameter	Information
Compatibility	Compatible with breastfeeding; considered safe
Expected Drug Level in Milk	Very low (approximately 1–2% of maternal dose reaches infant)
Risk to Infant	No significant adverse effects reported at therapeutic maternal doses
Preferred Alternatives	None — paracetamol is preferred analgesic/antipyretic during breastfeeding
Infant Monitoring	None routinely required; observe for rash (rare) with prolonged maternal use

Elderly

Parameter	Recommendation
Starting dose	500 mg orally every 6–8 hours
Titration	Not applicable
Maximum recommended	3000 mg/day (reduced from standard adult maximum)
Increased Risks	Hepatotoxicity (particularly if malnourished or with chronic alcohol use); accumulation if unrecognised renal or hepatic impairment
Additional Precautions	Use lower doses in frail elderly or those with low body weight (<50 kg); assess for concurrent paracetamol intake from combination products; prefer paracetamol over NSAIDs due to superior GI and renal safety profile

Major drug interactions

Interacting Drug	Mechanism	Effect	Management
Chronic Alcohol (>3 drinks/day)	CYP2E1 induction; glutathione depletion	Significantly increased hepatotoxicity risk even at therapeutic doses	Limit maximum daily dose to 2000 mg; counsel patients; avoid if possible
Warfarin (high-dose paracetamol >2 g/day for >3 days)	Unknown mechanism; possible inhibition of vitamin K-dependent factors	Potentiation of anticoagulant effect; increased INR	Monitor INR closely; may need warfarin dose reduction; occasional/low-dose use unlikely to be significant
Isoniazid	CYP2E1 induction; increased NAPQI (toxic metabolite) formation	Increased hepatotoxicity risk	Monitor LFTs; use lowest effective paracetamol dose; counsel patient
Rifampicin	CYP enzyme induction; increased NAPQI formation	Increased hepatotoxicity risk; possible reduced analgesic efficacy	Monitor LFTs; limit paracetamol use during TB treatment if possible

Moderate drug interactions

Interacting Drug	Effect	Management
Phenytoin, Carbamazepine, Phenobarbital	CYP enzyme induction; increased NAPQI formation; possible reduced paracetamol efficacy	Use with caution for prolonged periods; monitor for hepatotoxicity
Lamotrigine	Paracetamol may increase lamotrigine clearance (via UGT induction)	Monitor lamotrigine levels/efficacy if concurrent chronic use
Metoclopramide, Domperidone	Increased rate of paracetamol absorption	Generally beneficial for faster analgesia; no dose adjustment needed
Cholestyramine	Reduced paracetamol absorption	Separate administration by at least 1 hour
Chloramphenicol (IV)	Reduced chloramphenicol clearance	Monitor chloramphenicol levels; clinical relevance uncertain
Zidovudine (AZT)	Possible increased risk of neutropenia	Monitor blood counts with prolonged concurrent use

Common Adverse effects

Nausea (uncommon at therapeutic doses)
Rash, pruritus (uncommon)
Hypersensitivity reactions (uncommon)

Note: Paracetamol has an excellent safety profile at therapeutic doses. Most adverse effects occur with overdose or prolonged high-dose use.

Serious Adverse effects

Adverse Effect	Clinical Action
Acute Hepatotoxicity / Fulminant Hepatic Failure (with overdose >150 mg/kg or >7.5 g in adults, or chronic supratherapeutic dosing)	Discontinue immediately; check serum paracetamol level at 4 hours post-ingestion; initiate N-acetylcysteine (NAC) per Rumack-Matthew nomogram; hepatology/poison centre consultation; may require liver transplant in severe cases
Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis (rare)	Discontinue permanently; dermatology consultation; supportive care; hospitalisation
Anaphylaxis (rare)	Discontinue permanently; emergency management
Agranulocytosis / Thrombocytopenia (very rare)	Discontinue; haematology consultation
Acute Generalised Exanthematous Pustulosis (AGEP) (very rare)	Discontinue; dermatology consultation

Paracetamol Overdose Management:

Toxic dose: >150 mg/kg or >7.5 g (whichever is lower) in adults; >200 mg/kg in children
Obtain serum paracetamol level at 4 hours post-ingestion (or as soon as possible if presentation delayed)
N-acetylcysteine (NAC) is life-saving; initiate based on Rumack-Matthew nomogram or if toxic dose ingested (even before levels available if >8 hours since ingestion)
Contact National Poison Information Centre (AIIMS) for guidance: 1800-116-117

Monitoring requirements

Timing	Parameters
Baseline	Not required for short-term use in healthy patients; LFTs if hepatic risk factors present or planned prolonged use
Short-term use (<5 days)	No routine monitoring required
Prolonged/Chronic use (>5–7 days)	LFTs (baseline and periodic); assess total paracetamol intake from all sources
High-risk patients (alcoholism, malnutrition, hepatic disease)	LFTs before initiation and periodically during use
Suspected overdose	Serum paracetamol level at 4 hours post-ingestion; LFTs (AST, ALT, bilirubin); PT/INR; renal function; blood glucose

Brands in India

Oral Tablets:

Crocin™ (GSK) — 500 mg, 650 mg
Calpol™ (GSK) — 500 mg
Dolo™ (Micro Labs) — 650 mg
Pacimol™ (Ipca) — 500 mg, 650 mg
Pyrigesic™ (East India) — 500 mg
Metacin™ (Aristo) — 500 mg
Paracip™ (Cipla) — 500 mg, 650 mg

Paediatric Formulations (Syrups/Drops):

Calpol™ Paediatric Suspension — 120 mg/5 mL, 250 mg/5 mL
Crocin™ Drops — 100 mg/mL
Pacimol™ Drops — 100 mg/mL
T-98™ Drops — 100 mg/mL
Febrinil™ — 125 mg/5 mL

Intravenous:

Perfalgan™ (Bristol-Myers Squibb) — 10 mg/mL (100 mL vial)
Aceparon™ — 10 mg/mL
Paracip IV™ (Cipla) — 10 mg/mL

Suppositories:

Crocin™ Suppository — 125 mg, 250 mg
Febrinil™ Suppository — 80 mg, 170 mg

Fixed-Dose Combinations (Examples):

Paracetamol + Ibuprofen (Combiflam™)
Paracetamol + Tramadol (Ultracet™)
Paracetamol + Caffeine + Various analgesics (multiple OTC brands)

⚠️ Important: Always calculate total paracetamol intake from all sources including FDCs.

Price range (INR)

500 mg tablet	₹0.20–₹0.60 per tablet	NLEM listed; NPPA price controlled
650 mg tablet	₹0.50–₹2.00 per tablet	—
1000 mg tablet	₹2.00–₹4.00 per tablet	—
Syrup (60 mL)	₹15–₹45	—
Paediatric drops (15 mL)	₹20–₹50	—
IV infusion (100 mL = 1000 mg)	₹80–₹220 per vial	Significant cost,reserve for appropriate indications
Suppositories	₹8–₹15 per suppository	—

Regulatory: Listed under NLEM 2022 (500 mg tablet, paediatric oral liquid); NPPA price controlled for scheduled strengths

Clinical pearls

Calculate total daily dose from ALL sources — Paracetamol is present in numerous FDCs (cold/flu preparations, analgesic combinations); inadvertent overdose is common; always ask about OTC medication use
Preferred analgesic/antipyretic in special populations — First-line in pregnancy, breastfeeding, children <6 months, elderly with GI/CV/renal risk, dengue fever (avoid NSAIDs), and patients on anticoagulants
IV paracetamol is expensive — Reserve for patients genuinely unable to take oral medications; switch to oral route as soon as feasible; efficacy is similar (IV has faster onset)
Hepatotoxicity risk in "at-risk" patients — Chronic alcoholics, malnourished patients, and those on enzyme inducers (isoniazid, rifampicin, phenytoin) may develop hepatotoxicity at therapeutic doses; limit to 2000–3000 mg/day in these patients
Early NAC is life-saving in overdose — Do not delay NAC therapy waiting for paracetamol levels if toxic dose ingested >8 hours ago; the 4-hour level guides but should not delay treatment in late presenters
Weight-based dosing in children is essential — Use calibrated measuring devices for liquid formulations; avoid household spoons; ensure caregiver understanding

Version

RxIndia v1.1 — 11 Apr 2025

Reference

CDSCO Product Information
Indian Pharmacopoeia (IP)
National List of Essential Medicines (NLEM) 2022
API Textbook of Medicine
AIIMS Drug Formulary
IAP Guidelines — Fever Management in Children
MoHFW Paediatric Dosing Guidelines
ICMR Guidelines on Rational Use of Analgesics
National Poison Information Centre (AIIMS) — Paracetamol Toxicity Management Protocol
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Harrison's Principles of Internal Medicine
Perfalgan™ / IV Paracetamol Prescribing Information (India)
RCTs on Paracetamol for PDA closure (Hammerman et al., Ohlsson et al.) — off-label evidence

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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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