Ergotamine Uses, Dosage, Side Effects & Warnings | DrugsAtlas
Authoritative Clinical Reference
Navigation
DRUG NAME: Ergotamine
Therapeutic Class: Antimigraine agent
Subclass: Ergot alkaloid
Speciality: Neurology
Schedule (India): Schedule H
Route(s): Oral, sublingual
Formulations Available in India:
• Sublingual tablets: Ergotamine tartrate 1 mg + Caffeine 100 mg (FDC)
• Rectal suppositories: NOT AVAILABLE in India
• Injectable forms: NOT AVAILABLE in India
• Sublingual tablets: Ergotamine tartrate 1 mg + Caffeine 100 mg (FDC)
• Rectal suppositories: NOT AVAILABLE in India
• Injectable forms: NOT AVAILABLE in India
Note: Ergotamine monotherapy is NOT AVAILABLE in India; only marketed as fixed-dose combination with caffeine.
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Acute Migraine Attacks (with or without aura)
Important: Ergotamine is NOT first-line therapy. Use only when triptans are contraindicated, unavailable, or ineffective.
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 tablet (Ergotamine 1 mg + Caffeine 100 mg) sublingually at onset of headache |
| Titration | May repeat 1 tablet every 30 minutes if inadequate relief |
| Usual maintenance dose | Not applicable — acute treatment only |
| Maximum dose | 3 tablets (3 mg ergotamine) per attack |
Dosing Limits:
| Limit Type | Maximum |
|---|---|
| Per attack | 3 mg ergotamine |
| Per 24 hours | 6 mg ergotamine |
| Per week | 10 mg ergotamine |
Clinical Notes:
- Must be administered early in migraine attack for optimal efficacy
- Co-administration with antiemetics (e.g., domperidone, metoclopramide) improves tolerability
- Avoid use during prolonged aura phase
- Contraindicated in hemiplegic or basilar-type migraine
Secondary Indications – Adults (Off-label, if any)
Cluster Headache — OFF-LABEL, Specialist Only
| Parameter | Recommendation |
|---|---|
| Starting dose | 1 tablet (Ergotamine 1 mg + Caffeine 100 mg) sublingually at onset of cluster attack |
| Titration | May repeat once after 30 minutes if needed |
| Usual maintenance dose | Intermittent dosing during cluster periods |
| Maximum dose | As per migraine limits (6 mg/24 hours; 10 mg/week) |
| Duration | Up to 6 weeks during cluster period |
Evidence basis: Historical use supported by small studies; largely replaced by sumatriptan injection and verapamil prophylaxis in current Indian neurology practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
NOT RECOMMENDED in children and adolescents below 18 years.
- No approved paediatric formulations in India
- No validated safety or efficacy data in paediatric population
- Heightened risk of vasospasm and ergot toxicity in younger age groups
⚠️ Use only under specialist neurology supervision in exceptional refractory migraine cases.
Secondary Indications – Paediatric Doses (Off-label, if any)
Not applicable — No validated off-label paediatric indications.
RENAL ADJUSTMENT
| Renal Status | Recommendation |
|---|---|
| Mild impairment (eGFR 60–89) | Use with caution; do not exceed standard weekly limits |
| Moderate impairment (eGFR 30–59) | AVOID — risk of accumulation and vasospasm |
| Severe impairment (eGFR <30) | CONTRAINDICATED |
| Haemodialysis | Not dialyzable; AVOID use |
HEPATIC ADJUSTMENT
| Hepatic Status | Recommendation |
|---|---|
| Mild impairment | Use lowest effective dose; close monitoring required |
| Moderate impairment | AVOID — impaired hepatic metabolism increases toxicity risk |
| Severe impairment | CONTRAINDICATED |
CONTRAINDICATIONS
- Pregnancy (absolute contraindication)
- Coronary artery disease, angina pectoris, recent myocardial infarction
- Peripheral vascular disease (Buerger's disease, Raynaud's phenomenon)
- Uncontrolled hypertension
- Hemiplegic migraine or basilar-type migraine
- Severe renal impairment (eGFR <30)
- Severe hepatic impairment
- Concurrent use with potent CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, erythromycin, clarithromycin)
- Use within 24 hours of triptan administration
- Known hypersensitivity to ergot alkaloids
- Sepsis or severe systemic infection
CAUTIONS
- Smokers aged >35 years — significantly increased vasospasm risk
- Elderly patients — enhanced sensitivity to vasoconstrictive effects
- Mild renal impairment — do not exceed weekly dosing limits
- Prolonged migraine duration before dosing — reduced efficacy and increased adverse effects
- Risk of medication-overuse headache (MOH) with frequent use (>10 days/month)
- Cumulative weekly dosing must be strictly monitored
- Avoid in patients with multiple cardiovascular risk factors
PREGNANCY
| Parameter | Information |
|---|---|
| Risk category | Contraindicated (Category X equivalent) |
| Overall safety | Ergot alkaloids cause potent uterine contractions and fetal hypoxia |
| Preferred alternatives | Paracetamol (first-line); sumatriptan under specialist supervision if required |
| When it may be used | NEVER — absolute contraindication in pregnancy |
| Monitoring if inadvertent exposure | Monitor for uterine cramping, vaginal bleeding, fetal distress |
LACTATION
| Parameter | Information |
|---|---|
| Compatibility | NOT compatible with breastfeeding |
| Preferred alternatives | Paracetamol, ibuprofen for mild-moderate migraine pain |
| Expected levels in milk | Significant excretion; ergotism reported in breastfed infants |
| What to monitor in infant | Sedation, vomiting, poor feeding, diarrhoea, signs of vasoconstriction |
Recommendation: If use unavoidable, pump and discard breast milk for at least 24 hours after dose.
ELDERLY
| Parameter | Recommendation |
|---|---|
| Recommended starting dose | Lowest available dose (1 tablet); generally best avoided |
| Need for slower titration | Yes — avoid repeated dosing if possible |
| Extra risks | Exaggerated vasospasm, peripheral ischaemia, coronary events, hypertensive crisis |
Monitoring: Closely observe for peripheral signs of ergotism (cyanosis, numbness, tingling in extremities, cold digits).
MAJOR DRUG INTERACTIONS
| Interacting Drug/Class | Mechanism | Recommendation |
|---|---|---|
| Potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, erythromycin, clarithromycin) | Decreased ergotamine metabolism; severe ergotism risk | CONTRAINDICATED — risk of vasospasm, stroke, MI |
| Triptans (sumatriptan, rizatriptan, etc.) | Additive vasoconstriction | AVOID — do not use within 24 hours of each other |
| Protease inhibitors (ritonavir, indinavir, nelfinavir) | Strong CYP3A4 inhibition | CONTRAINDICATED |
| Beta-blockers (propranolol) | Enhanced peripheral vasoconstriction | AVOID combination; if essential, close monitoring |
| Other ergot derivatives (dihydroergotamine, methysergide) | Additive ergot toxicity | CONTRAINDICATED |
MODERATE DRUG INTERACTIONS
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| SSRIs/SNRIs | Rare risk of serotonin syndrome | Monitor for agitation, hyperthermia, tremor |
| Antihypertensives | Reduced antihypertensive efficacy due to vasoconstriction | Monitor blood pressure |
| Moderate CYP3A4 inhibitors (fluconazole, diltiazem, verapamil) | Potential increased ergotamine levels | Use with caution; monitor for vasospasm |
| Caffeine (additional exogenous) | Increased ergotamine absorption and effect | Moderate additional caffeine intake |
| Nicotine (smoking) | Synergistic vasoconstriction | Counsel smoking cessation; increased ergotism risk |
COMMON ADVERSE EFFECTS
- Nausea and vomiting
- Paraesthesia (tingling, numbness in fingers/toes)
- Dizziness
- Muscle cramps
- Abdominal discomfort
- Fatigue
- Weakness in legs
SERIOUS ADVERSE EFFECTS
- Peripheral ischaemia and gangrene — may necessitate amputation
- Coronary vasospasm — angina, myocardial infarction
- Stroke (cerebral vasospasm)
- Hypertensive crisis
- Fibrotic complications (with chronic overuse — retroperitoneal, pleural, cardiac valve fibrosis)
- Medication-overuse headache (MOH) with chronic use
- Ergotism syndrome (severe vasospasm with extremity necrosis)
⚠️ Immediate discontinuation required if any signs of ischaemia develop (cold extremities, cyanosis, severe limb pain).
MONITORING REQUIREMENTS
| Timing | Parameters |
|---|---|
| Baseline | Blood pressure, cardiac history (coronary risk), peripheral vascular assessment, renal and hepatic function |
| During acute use | Signs of vasospasm — extremity pain, colour changes, coldness, cyanosis |
| With recurrent use | Headache frequency diary — assess for medication-overuse headache |
| Long-term | Ensure weekly dose limits strictly maintained; monitor for fibrotic complications if prolonged use |
BRANDS AVAILABLE IN INDIA
- Cafergot (Ergotamine 1 mg + Caffeine 100 mg) — Novartis/Sandoz
- Migril (Ergotamine 1 mg + Caffeine 100 mg) — Various manufacturers
- Vasograin (Ergotamine + Caffeine + Paracetamol + Prochlorperazine) — Cadila
Note: Only available as FDC with caffeine; ergotamine monotherapy not marketed in India.
PRICE RANGE (INR)
| Formulation | Price Range |
|---|---|
| Ergotamine 1 mg + Caffeine 100 mg tablet | ₹5–10 per tablet |
| Vasograin-type FDC | ₹3–6 per tablet |
Note: Not included in NLEM; not under NPPA price control. Minimal use in government sector due to triptan preference.
CLINICAL PEARLS
- Administer at the earliest onset of migraine — delayed dosing significantly reduces efficacy and increases adverse effects
- Strictly enforce weekly dosing limits (≤10 mg/week) to prevent ergotism and medication-overuse headache
- Ergotamine is now considered second-line or last-resort for migraine; triptans are safer and more effective alternatives
- Avoid in smokers >35 years, patients with any vascular disease, or those on CYP3A4 inhibitors
- Co-prescribe domperidone or metoclopramide to manage nausea associated with ergotamine use
- Educate patients about signs of vasospasm (cold/blue fingers, numbness) requiring immediate discontinuation
TAGS
Ergotamine; migraine; ergot alkaloid; vasoconstrictor; CYP3A4 substrate; pregnancy-contraindicated; MOH risk; cluster headache; Schedule H; not-NLEM
VERSION
RxIndia v0.9 — 18 Feb 2026
REFERENCES
- CDSCO Approved Formulations List
- Indian Pharmacopoeia
- API Textbook of Medicine
- AIIMS Drug Formulary
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
- Harrison's Principles of Internal Medicine
- Indian neurology specialist protocols
- Historical RCTs for ergotamine in cluster headache (off-label reference only)
⚖️
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.