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DICLAREAL (diclofenac sodium/capsaicin)
2 %-0.025 % topical combo pack
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- Aspirin exacerbated respiratory disease
- Drug-induced hepatitis
- Post-operative from CABG surgery
- Pregnancy
- Severe hepatic disease
Contraindicated
- Abnormal hepatic function tests
- Acute myocardial infarction
- Alcohol use disorder
- Burns
- Cerebrovascular accident
- Chronic heart failure
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Debilitation
- Gastrointestinal hemorrhage
- Gastrointestinal ulcer
- Increased risk of bleeding
- Peptic ulcer
- Systemic mastocytosis
- Tobacco smoker
Severe
Moderate
- Anemia
- Asthma
- Disease of liver
- Edema
- Hypertension
DICLAREAL (diclofenac sodium/capsaicin)
- None
- Blistering skin
- Contact dermatitis
- Dry skin
- Pruritus of skin
More Frequent
Severe
Less Severe
- None
- Acute pain at drug application site
- Bruising
- Contact dermatitis
- Drowsy
- Dysgeusia
- Dyspepsia
- Edema
- Erythema
- Headache disorder
- Nausea
- Paresthesia
- Pruritus of skin
- Skin inflammation
- Skin rash
- Skin ulcer
- Stinging of skin
- Treatment site sequelae
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Acute myocardial infarction
- Anaphylaxis
- Anemia
- Asthma
- Body fluid retention
- Burns
- Cerebrovascular accident
- DRESS syndrome
- Exfoliative dermatitis
- Gastric ulcer
- Gastroenteritis
- Gastrointestinal hemorrhage
- Gastrointestinal perforation
- Gastrointestinal ulcer
- Heart failure
- Hepatic failure
- Hepatic necrosis
- Hepatitis
- Hypertension
- Jaundice
- Platelet aggregation inhibition
- Rectal bleeding
- Renal papillary necrosis
- Stevens-johnson syndrome
- Tongue swelling
- Toxic epidermal necrolysis
Less Severe
- Cataracts
- Cough
- Cramps in legs
- Depression
- Diarrhea
- Dizziness
- Dysgeusia
- Eczema
- Gastritis
- Halitosis
- Headache disorder
- Hyperkinesis
- Hypertension
- Hypoesthesia
- Localized edema
- Myalgia
- Ocular pain
- Palpitations
- Reduced sensation of skin
- Sinusitis
- Stinging of skin
- Urinary tract infection
- Visual changes
- Xerostomia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Diclofenac (Select Routes)
Safety and efficacy in pediatrics have not been established.
- 1 Day – 18 Years
- Safety and efficacy in pediatrics have not been established.
Capsicum
- Severity Level:
2
- Additional Notes: Insufficient human data available on developmental toxicity risk.
Diclofenac
- Severity Level:
1
- Additional Notes: Not recommended near or after 20 weeks gestation
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Capsaicin (topical)
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
Diclofenac (top)
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Diclofenac (topical)
Gastrointestinal-Caution with history of PUD or GI bleed. Renal-Monitor patients with renal impairment. Cardiovascular-May exacerbate pre-existing hypertension, CHF. Cardiovascular thrombotic event risk, including MI and stroke, increases with duration of use. Risk for reinfarction with minimal NSAID use post-MI. Contraindicated in the setting of CABG. Hepatic-Elevated hepatic transaminases may occur with chronic use.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | Y | Y | N | N | N |
BEERS: Y HEDIS: N STOPP: Y
No Known Risk
None
- Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes).<br /><br />Do not use this drug right before or after heart bypass surgery (CABG). Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning symptoms at any time while using diclofenac.<br /><br />Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.) Stop using diclofenac and get medical help right away if you notice any of the following rare but very serious side effects: stomach/abdominal pain that doesn't go away, black/bloody stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, sudden vision changes, trouble speaking. Talk with your doctor or pharmacist about the benefits and risks of using this medication.
Formulary Reference Tool