ORPHENADRINE CITRATE

N/A

Manufactured by Actavis Pharma, Inc.

1,883 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ORPHENADRINE CITRATE

ORPHENADRINE CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. The most commonly reported adverse reactions for ORPHENADRINE CITRATE include PAIN, NAUSEA, ANXIETY, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ORPHENADRINE CITRATE.

Top Adverse Reactions

PAIN64 reports
NAUSEA51 reports
ANXIETY45 reports
DRUG INEFFECTIVE45 reports
FATIGUE45 reports
ARTHRALGIA41 reports
HEADACHE40 reports
DIARRHOEA35 reports
DIZZINESS35 reports
DYSPNOEA30 reports
VOMITING30 reports
BLOOD CHOLESTEROL INCREASED29 reports
DRUG HYPERSENSITIVITY29 reports
ANAEMIA28 reports
ARTHRITIS27 reports
INFECTION27 reports
PERIPHERAL SWELLING27 reports
ASTHENIA26 reports
FALL26 reports
HERPES ZOSTER26 reports
JOINT SWELLING26 reports
CHRONIC KIDNEY DISEASE24 reports
FIBROMYALGIA23 reports
MUSCLE SPASMS23 reports
ORAL PAIN23 reports
BACK PAIN22 reports
LEUKOPENIA22 reports
PNEUMONIA VIRAL22 reports
RHEUMATOID ARTHRITIS22 reports
SOMNOLENCE22 reports
LIVER FUNCTION TEST ABNORMAL21 reports
PRODUCT USE ISSUE21 reports
SYNOVITIS21 reports
HYPERTENSION20 reports
WEIGHT DECREASED20 reports
CONDITION AGGRAVATED19 reports
PAIN IN EXTREMITY19 reports
TREMOR19 reports
CONFUSIONAL STATE18 reports
CONSTIPATION18 reports
COUGH18 reports
MALAISE18 reports
PRURITUS18 reports
RENAL FAILURE18 reports
TENDERNESS18 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE18 reports
URINARY TRACT INFECTION18 reports
ABDOMINAL PAIN UPPER17 reports
DEPRESSION17 reports
INSOMNIA17 reports
MYALGIA17 reports
OFF LABEL USE17 reports
ACUTE KIDNEY INJURY16 reports
DRUG INTOLERANCE16 reports
RASH16 reports
SWELLING16 reports
CARDIAC FAILURE CONGESTIVE15 reports
INJURY15 reports
STOMATITIS15 reports
GAIT DISTURBANCE14 reports
HYPERSENSITIVITY14 reports
CHEST PAIN13 reports
SINUSITIS13 reports
SOFT TISSUE DISORDER13 reports
C REACTIVE PROTEIN ABNORMAL12 reports
DEATH12 reports
DEEP VEIN THROMBOSIS12 reports
GASTROOESOPHAGEAL REFLUX DISEASE12 reports
HYPOAESTHESIA12 reports
PALPITATIONS12 reports
TOXICITY TO VARIOUS AGENTS12 reports
VISION BLURRED12 reports
ASTHMA11 reports
MEMORY IMPAIRMENT11 reports
NASOPHARYNGITIS11 reports
OEDEMA PERIPHERAL11 reports
PNEUMONIA11 reports
WEIGHT INCREASED11 reports
ABDOMINAL DISCOMFORT10 reports
ABDOMINAL PAIN10 reports
C REACTIVE PROTEIN INCREASED10 reports
CONTUSION10 reports
DIABETES MELLITUS10 reports
EMOTIONAL DISTRESS10 reports
INJECTION SITE PAIN10 reports
LOSS OF CONSCIOUSNESS10 reports
NECK PAIN10 reports
OROPHARYNGEAL PAIN10 reports
PYREXIA10 reports
DECREASED APPETITE9 reports
DYSPEPSIA9 reports
ECONOMIC PROBLEM9 reports
MUSCULOSKELETAL PAIN9 reports
OCULOGYRIC CRISIS9 reports
ABDOMINAL DISTENSION8 reports
ACUTE HEPATIC FAILURE8 reports
BURNING SENSATION8 reports
CHOLECYSTITIS CHRONIC8 reports
DELIRIUM8 reports
DRY MOUTH8 reports

Report Outcomes

Out of 601 classified reports for ORPHENADRINE CITRATE:

Serious 68.4%Non-Serious 31.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female428 (74.7%)
Male141 (24.6%)
Unknown4 (0.7%)

Reports by Age

Age 5818 reports
Age 7616 reports
Age 4911 reports
Age 6311 reports
Age 4310 reports
Age 4610 reports
Age 5410 reports
Age 5910 reports
Age 509 reports
Age 539 reports
Age 568 reports
Age 648 reports
Age 227 reports
Age 417 reports
Age 427 reports
Age 517 reports
Age 527 reports
Age 657 reports
Age 667 reports
Age 747 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ORPHENADRINE CITRATE?

This profile reflects 1,883 FDA FAERS reports that mention ORPHENADRINE CITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ORPHENADRINE CITRATE?

Frequently reported terms in FAERS include PAIN, NAUSEA, ANXIETY, DRUG INEFFECTIVE, FATIGUE, ARTHRALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ORPHENADRINE CITRATE?

Labeling and FAERS entries often list Actavis Pharma, Inc. in connection with ORPHENADRINE CITRATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.