pharmacopeia
GET
/api/v1/drug/orphenadrine
2D structure
N,N-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine
SMILES CC1=CC=CC=C1C(C2=CC=CC=C2)OCCN(C)C
InChIKey QVYRGXJJSLMXQH-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Contraindications

Sourced from openFDA
  • Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.contraindicated

Dosage & administration

Sourced from openFDA

Adults Two tablets per day; one in the morning and one in the evening.

Warnings & precautions

Sourced from openFDA

Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Adverse reactions

Sourced from openFDA

Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.

Approval history

Sourced from openFDA
  • Mar 15, 1982ANDAANDA084779Watson Labs
  • May 29, 1998ANDAANDA075141Galt Pharms
  • Jun 19, 1998ANDAANDA040284Lupin
  • Feb 15, 2000ANDAANDA040327Sandoz
  • Mar 4, 2003ANDAANDA040463Hikma
  • Aug 30, 2011ANDAANDA090585Sagent Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
735 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea699.4%
  2. 2Pain699.4%
  3. 3Fatigue577.8%
  4. 4Headache516.9%
  5. 5Drug Ineffective506.8%
  6. 6Anxiety496.7%
  7. 7Dizziness466.3%
  8. 8Diarrhoea446.0%
  9. 9Arthralgia435.9%
  10. 10Drug Hypersensitivity405.4%
  11. 11Vomiting375.0%
  12. 12Dyspnoea354.8%
  13. 13Anaemia304.1%
  14. 14Blood Cholesterol Increased304.1%
  15. 15Fall293.9%

Literature

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Recent PubMed references pinned to Orphenadrine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 17 ClinicalTrials.gov registrations naming Orphenadrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Orphenadrine work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Orphenadrine used for?
According to FDA labeling, Orphenadrine carries indications including: Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Orphenadrine?
Orphenadrine is classified as Muscle Relaxant, Unknown Cellular or Molecular Interaction, Centrally-mediated Muscle Relaxation, Decreased Central Nervous System Organized Electrical Activity, Increased Esophageal Muscle Tone, Striated Muscle Metabolic Alteration.
What are the brand names for Orphenadrine?
Orphenadrine is marketed under brand names including Norgesic, Orphengesic.
What are the contraindications for Orphenadrine?
Orphenadrine labeling lists contraindications including: Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for orphenadrine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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