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The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular thrombotic events [see Boxed Warning and WARNINGS AND PRECAUTIONS]
  • Gastrointestinal effects [see Boxed Warning and WARNINGS AND PRECAUTIONS]
  • Hepatic effects [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Congestive Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
  • Renal Effects [see WARNINGS AND PRECAUTIONS]
  • Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions reported with CAMBIA (diclofenac potassium for oral solution) are nausea and dizziness.

The most common adverse events resulting in discontinuation of patients following CAMBIA (diclofenac potassium for oral solution) dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).

Clinical Studies Experience with CAMBIA (diclofenac potassium for oral solution)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of a single dose of CAMBIA (diclofenac potassium for oral solution) was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with CAMBIA (diclofenac potassium for oral solution) for a single migraine headache. Following treatment with diclofenac potassium (either CAMBIA or diclofenac potassium immediate-release tablets [as a control]), 5 subjects (0.8%) withdrew from the studies; following placebo exposure, 1 subject (0.2%) withdrew. No withdrawals were due to a serious reaction.

The most common adverse reactions (i.e., that occurred in 1% or more of CAMBIA (diclofenac potassium for oral solution) -treated patients) and more frequent with CAMBIA (diclofenac potassium for oral solution) than with placebo were nausea and dizziness (see Table 1).

Table 1: Treatment-Related Adverse Reactions with Incidence > 1% and Greater than Placebo in Studies 1 and 2 Combined

Disorder Event CAMBIA
N=634
Placebo
N=646
Gastrointestinal
  Nausea 3% 2%
Nervous System
  Dizziness 1% 0.5%

Adverse reactions reported with diclofenac and other NSAIDs

In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-10% of patients are: GI reactions (including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers [gastric/duodenal], and vomiting), abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Additional adverse reactions reported in patients taking NSAIDs include occasionally:

Body as a Whole: Fever, infection, sepsis

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope

Digestive System: Dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice

Hemic and Lymphatic System: Ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia

Metabolic and Nutritional: Weight changes

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory System: Asthma, dyspnea

Skin and Appendages: Alopecia, photosensitivity, sweating increased

Special Senses: Blurred vision

Urogenital System: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure

Other adverse reactions in patients taking NSAIDs, which occur rarely , are:

Body as a Whole: Anaphylactic reactions, appetite changes, death

Cardiovascular System: Arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis

Digestive System: Colitis, eructation, liver failure, pancreatitis

Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Metabolic and Nutritional: Hyperglycemia

Nervous System: Convulsions, coma, hallucinations, meningitis

Respiratory System: Respiratory depression, pneumonia

Skin and Appendages: Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria

Special Senses: Conjunctivitis, hearing impairment.