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MILNACIPRAN HYDROCHLORIDE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following additional adverse reactions have been identified from spontaneous reports of Savella received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella. However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:
  • Blood and Lymphatic System Disorders — leukopenia, neutropenia, thrombocytopenia
  • Cardiac Disorders — supraventricular tachycardia, Takotsubo cardiomyopathy
  • Eye Disorders — accommodation disorder
  • Endocrine Disorders — hyperprolactinemia
  • Gastrointestinal Disorders — acute pancreatitis
  • Hepatobiliary Disorders — hepatitis
  • Metabolism and Nutrition Disorders — anorexia, hyponatremia
  • Musculoskeletal and Connective Tissue Disorders — rhabdomyolysis
  • Nervous System Disorders — convulsions (including grand mal), loss of consciousness, Parkinsonism
  • Psychiatric Disorders — aggression, anger, delirium, hallucination, homicidal ideation
  • Renal and Urinary Disorders — acute renal failure
  • Reproductive System and Breast Disorders — galactorrhea
  • Skin Disorders — erythema multiforme, Stevens Johnson syndrome
  • Vascular Disorders — hypertensive crisis

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
11
42901
Other ADRs
2639
14114640

Odds Ratio = 1.372

Drug Property Information



ATC Code(s):
  • N06AX17 - milnacipran hydrochloride
    • N06AX - Other antidepressants
    • N06A - ANTIDEPRESSANTS
    • N06 - PSYCHOANALEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:milnacipran hydrochloride
Active Ingredient UNII:RNZ43O5WW5
Drugbank ID:DB04896
PubChem Compound:65833
CAS Number:92623-85-3
Dosage Form(s):kit; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 100.0 mg/day N06AX17
Chemical Structure:
SMILE Code:
CCN(CC)C(=O)[C@@]1(C[C@@H]1CN)C2=CC=CC=C2

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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