What are the potential side effects of taking Voveran SR (Diclofenac) 100mg?

Side Effects of Voveran SR (Diclofenac) 100mg

Diclofenac 100mg carries significant cardiovascular and gastrointestinal risks that require careful consideration before prescribing, with the FDA mandating black box warnings for increased risk of serious cardiovascular thrombotic events, myocardial infarction, stroke, and life-threatening GI bleeding, ulceration, and perforation. 1, 2

Cardiovascular Side Effects (Highest Priority for Morbidity/Mortality)

Diclofenac demonstrates the highest cardiovascular risk among traditional NSAIDs, with substantially elevated rates compared to other options:

• Vascular events: Relative risk of 1.63 (95% CI 1.12-2.37) versus placebo 1, 3
• Cardiovascular events (mostly MI): Relative risk of 1.40 (95% CI 1.16-1.70) 1
• Recurrent MI: Relative risk of 1.54 (95% CI 1.23-1.93) 1
• Mortality: Relative risk of 2.40 (95% CI 2.09-2.80) - the most concerning finding 1, 3
• Risk increases with duration of use and is present even in patients without established cardiovascular disease 1, 2

Gastrointestinal Side Effects

Common GI effects (occurring in 1-10% of patients): 2, 4

• Abdominal pain
• Dyspepsia (indigestion)
• Nausea and vomiting
• Diarrhea or constipation
• Flatulence
• Heartburn

Serious GI complications (can occur without warning symptoms): 1, 2

• GI bleeding and perforation (can be fatal)
• Gastric/duodenal ulcers
• Risk is particularly elevated in elderly patients (≥75 years) 1
• Diclofenac shows moderate effect on risk for serious upper GI events 3

Renal and Fluid Balance Side Effects

• Nephrotoxicity and acute kidney injury (especially when initiating or increasing dose) 1
• Edema and fluid retention 2
• Hyperkalemia 1
• Impaired blood pressure control and worsening of hypertension 1, 3
• Can precipitate or worsen heart failure 1, 2

Hepatic Side Effects

• Elevated liver enzymes (approximately 10% of patients) 2, 4
• Fulminant hepatitis with or without jaundice 2
• Liver failure and liver necrosis (rare but serious) 2
• Warning signs include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms 2

Neurological Side Effects

Common: 2, 4

• Headache
• Dizziness
• Drowsiness

Serious (rare): 2

• Confusion
• Convulsions
• Hallucinations
• Aseptic meningitis
• Coma

Hematologic Side Effects

• Anemia 2
• Increased bleeding time 2
• Agranulocytosis, hemolytic anemia, aplastic anemia (rare but serious) 2
• Pancytopenia 2

Dermatologic Side Effects

Common: 2

• Pruritus (itching)
• Rashes

Serious (rare but potentially fatal): 2

• Stevens-Johnson Syndrome
• Toxic epidermal necrolysis
• Erythema multiforme
• Exfoliative dermatitis
• Angioedema

Other Notable Side Effects

• Respiratory: Bronchospasm (especially in patients with asthma), respiratory depression, pneumonia 1, 2
• Sensory: Tinnitus, conjunctivitis, hearing impairment 2
• Metabolic: Hyperglycemia 2
• Hypersensitivity: Anaphylactic reactions (difficulty breathing, swelling of face or throat) 2

High-Risk Populations Requiring Extra Caution

Avoid diclofenac entirely in: 1, 3

• Patients ≥75 years with established cardiovascular disease
• Perioperative pain in coronary artery bypass graft (CABG) surgery 1, 2
• Active bleeding or history of GI bleeding 1
• Chronic kidney disease stage III or higher 5

Use with extreme caution in: 1, 3

• Patients with cardiovascular disease or multiple CV risk factors
• Elderly patients (higher risk for all adverse effects)
• Patients with history of peptic ulcer disease
• Patients taking anticoagulants, antiplatelets, SSRIs, SNRIs, or corticosteroids 1
• Patients with hepatic impairment 1
• Patients with heart failure 1, 2

Critical Monitoring Requirements

Mandatory monitoring includes: 1, 2

• Blood pressure (can cause or worsen hypertension)
• Renal function (baseline and periodic creatinine monitoring)
• Liver enzymes (periodic monitoring with long-term use)
• Signs of GI bleeding (melena, hematemesis, epigastric pain)
• Signs of heart failure (shortness of breath, unexplained weight gain, edema)
• Complete blood count with long-term use 2

Common Pitfalls to Avoid

• Never combine with other NSAIDs (including over-the-counter products like ibuprofen or aspirin) - increases risk without additional benefit 1, 5, 2
• Do not use with anticoagulants without gastroprotection - dramatically increases bleeding risk 1
• Avoid abrupt discontinuation in patients on long-term therapy 2
• Do not ignore early warning signs - serious complications can occur without preceding symptoms 2
• Pregnancy: Avoid after 30 weeks gestation (risk of premature closure of fetal ductus arteriosus); use caution between 20-30 weeks 2

Protective Strategies When Use Is Necessary

• Always prescribe the lowest effective dose for the shortest duration possible 1, 3, 6
• Add proton pump inhibitor for gastroprotection in all patients requiring chronic NSAID therapy, especially those ≥75 years or with GI risk factors 1, 3, 6
• Consider alternative agents with better safety profiles (naproxen has lower cardiovascular risk; topical NSAIDs have lower systemic absorption) 3, 5
• Screen for contraindications before prescribing, including cardiovascular disease, renal impairment, and bleeding risk 1, 3