Note: This document contains side effect information about diclofenac. Some dosage forms listed on this page may not apply to the brand name Cambia.

Applies to diclofenac: oral capsule, oral capsule liquid filled, oral powder for solution, oral tablet, oral tablet enteric coated, oral tablet extended release.

Serious side effects of Cambia

Along with its needed effects, diclofenac (the active ingredient contained in Cambia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diclofenac:

More common

• Acid or sour stomach
• belching
• bleeding gums
• blood in the urine or stools
• bloody or black, tarry stools
• burning while urinating
• chest pain
• chills
• cough
• clay-colored stools
• cloudy urine
• constipation
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• dizziness
• feeling of indigestion
• fever
• frequent urge to urinate
• headache
• heartburn
• increased bleeding time
• indigestion
• itching skin or rash
• light-colored stools
• loss of appetite
• nausea and vomiting
• pain in the chest below the breastbone
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• stomach bloating, burning, cramping, discomfort, upset, or pain
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling or inflammation of the mouth
• swollen glands
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting of blood or material that looks like coffee grounds
• weight loss
• yellow eyes and skin

Less common

• Blistering, peeling, loosening of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• confusion
• change in consciousness
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of constant movement of self or surroundings
• feeling sad or empty
• irritability
• joint or muscle pain
• lack of appetite
• lack or loss of strength
• loss of consciousness
• loss of interest or pleasure
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pale or blue lips, fingernails, or skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness, soreness, or itching skin
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• stiff neck or back
• trembling or shaking of the hands or feet
• trouble concentrating
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur while taking diclofenac:

Symptoms of overdose

• Agitation
• blurred vision
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• confusion
• depression
• difficult or trouble breathing
• hives
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• loss of consciousness
• muscle twitching
• nervousness
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• sleepiness
• slow or fast heartbeat
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects of Cambia

Some side effects of diclofenac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty in swallowing
• excess air or gas in the stomach or intestines
• hearing loss
• lack or loss of strength
• pain or burning in the throat
• passing gas

Less common

• Burning, dry or itching eyes
• discharge, excessive tearing
• hair loss, thinning of the hair
• increased sensitivity of the skin to sunlight
• pain in the arms or legs
• redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
• redness or other discoloration of the skin
• severe sunburn

For Healthcare Professionals

Applies to diclofenac: compounding powder, intravenous solution, oral capsule, oral delayed release tablet, oral powder for reconstitution, oral tablet, oral tablet extended release.

Gastrointestinal

Very common (10% or more): Nausea (up to 24%), constipation (up to 13%)

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, gastric and duodenal ulcers, vomiting

Rare (less than 0.1%): Colitis, eructation, pancreatitis

Frequency not reported: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, stomatitis^[Ref]

NSAIDs including this drug, can cause serious gastrointestinal (GI) events which can occur at any time, with or without warning. For patients who develop a serious upper GI event, only about 20% were symptomatic. Upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated with NSAIDs for 3 to 6 months and 2% to 4% of patients treated for 1 year. Patients with a prior history of peptic ulcer disease and/or GI bleeding had a greater than 10-fold increased risk for developing a GI bleed than patients with neither of these risk factors.^[Ref]

Hepatic

Borderline elevations of 1 or more liver tests to less than 3 times the upper limit of the normal (3 x ULN) or greater elevations in transaminases occurred in about 15% of patients treated with this drug. Elevations to greater than 3 x ULN of AST occurred in about 2% (n=5700) of patients at some point during treatment. In an open-labeled trial among patients receiving NSAIDs, a higher incidence of transaminase elevations were observed in patients receiving diclofenac (the active ingredient contained in Cambia) compared with other NSAIDs.^[Ref]

Common (1% to 10%): Elevated liver enzymes

Rare (less than 0.1%): Hepatitis, jaundice, liver disorder

Very rare (less than 0.01%): Fulminant hepatitis, hepatic necrosis, hepatic failure

Postmarketing reports: Drug-induced hepatotoxicity^[Ref]

Renal

Common (1% to 10%): Abnormal renal function, increased serum creatinine

Rare (less than 0.1%): Nephrotic syndrome, interstitial nephritis, renal papillary necrosis, acute renal failure, urinary frequency, nocturia, proteinuria, and hematuria^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rashes

Rare (less than 0.1%): Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria

Very rare (less than 0.01%): Bullous eruptions, eczema, erythema, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction

Frequency not reported: Increased sweating^[Ref]

Hematologic

Common (1% to 10%): Anemia, increased bleeding time

Rare (less than 0.1%): Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Very rare (less than 0.01%): Thrombocytopenia, leukopenia, positive Coombs' test

Frequency not reported: Ecchymosis, eosinophilia, melena, purpura, rectal bleeding^[Ref]

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria, rash, angioedema, bronchospasm

Rare (less than 0.1%): Anaphylactic reactions

Very rare (less than 0.01%): Angioneurotic edema (including facial edema)^[Ref]

Metabolic

Rare (less than 0.1%): Changes in appetite, hyperglycemia

Frequency not reported: Weight changes^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headaches

Rare (less than 0.1%): Meningitis

Very rare (less than 0.01%): Memory impairment

Frequency not reported: Confusion, drowsiness, insomnia, paresthesia, tremors^[Ref]

Cardiovascular

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.

Pharmacoepidemiological data reveal an increased risk of arteriothrombotic events associated with diclofenac (the active ingredient contained in Cambia) use, particularly at a high dose and during long-term treatment. In a meta-analysis of long-term treatment with diclofenac 150 mg/day, compared with placebo use of this drug resulted in approximately 3 additional major vascular events per 1000 participants.^[Ref]

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Cardiac failure, chest pain

Rare (less than 0.1%): Arrhythmia, hypotension, myocardial infarction, palpitations

Very rare (less than 0.01%): Vasculitis

Frequency not reported: Congestive heart failure, tachycardia, syncope, hypertension^[Ref]

Psychiatric

Rare (less than 0.1%): Hallucinations

Very rare (less than 0.01%): Disorientation, depression, nightmare, irritability, psychotic disorder

Frequency not reported: Anxiety, nervousness^[Ref]

Other

Common (1% to 10%): Tinnitus,

Rare (less than 0.1%): Hearing impairment

Frequency not reported: Fever, asthenia, vertigo^[Ref]

Ocular

Rare (less than 0.1%): Conjunctivitis

Very rare (less than 0.01%): Blurred vision, visual disturbance, diplopia

Frequency not reported: Optic neuritis

General

The most common adverse reactions among patients treated with this drug included; gastrointestinal events of abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding,/perforation, heartburn, nausea, gastric and duodenal ulcers, and vomiting; abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Genitourinary

Common (1% to 10%): Urinary tract infection

Frequency not reported: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria

Immunologic

Frequency not reported: Infection, sepsis

Local

Common (1% to 10%): Local reactions such as itching, burning, and increased bowel movement with suppository use

Very rare (less than 0.01%): Exacerbation of hemorrhoids with suppository use

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory infection, nasopharyngitis, bronchitis

Rare (less than 0.1%): Pneumonia

Frequency not reported: Asthma, dyspnea