Cambia
- Generic Name: diclofenac potassium for oral solution
- Brand Name: Cambia
Cambia (Diclofenac Potassium for Oral Solution) side effects drug center
Cambia Side Effects Center
What Is Cambia?
Cambia (diclofenac potassium) for Oral Solution is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis or ankylosing spondylitis. The powder form of this drug is used to treat a migraine headache attack. Cambia will only treat a headache that has already begun. Cambia will not prevent headaches or reduce the number of attacks.
What Are Side Effects of Cambia?
Common side effects of Cambia include:
- nausea,
- vomiting,
- stomach pain or upset,
- heartburn,
- indigestion,
- constipation,
- diarrhea,
- bloating,
- gas,
- dizziness,
- drowsiness,
- headache,
- nervousness,
- skin itching or rash,
- stuffy nose,
- increased sweating,
- blurred vision,
- ringing in your ears,
- increased blood pressure, or
- swelling or pain in your arms or legs.
Tell your doctor if you have unlikely but serious side effects of Cambia including:
- fainting,
- fast or pounding heartbeat,
- hearing changes (such as ringing in the ears),
- persistent or severe headache,
- sudden or unexplained weight gain,
- unusual tiredness, or
- vision changes.
Dosage for Cambia
Administer one packet (50 mg dose) of Cambia for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 mL) of water, mix well and drink immediately. Do not use liquids other than water.
What Drugs, Substances, or Supplements Interact with Cambia?
Cambia may interact with antidepressants, blood thinners, cyclosporine, isoniazid, lithium, methotrexate, pronbenecid, rifampin, secobarbital, sertraline, sulfamethoxazole, teniposide, zafirlukast, diuretics, steroids, antifungals, aspirin or other NSAIDs, cholesterol-lowering medicines, or heart or blood pressure medications. Tell your doctor all medications and supplements you use.
Cambia During Pregnancy and Breastfeeding
Before using Cambia, women should talk with their doctor about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, Cambia should be used only when prescribed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Cambia (diclofenac potassium) for Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Cambia Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using diclofenac and call your doctor at once if you have:
- the first sign of any skin rash, no matter how mild;
- flu-like symptoms;
- heart problems--swelling, rapid weight gain, feeling short of breath;
- kidney problems--little or no urinating, painful or difficult urination, swelling in your arms or legs, feeling tired or short of breath;
- liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- indigestion, gas, nausea, vomiting, stomach pain;
- diarrhea, constipation;
- headache, dizziness, drowsiness;
- abnormal lab tests;
- itching, sweating;
- stuffy nose;
- increased blood pressure; or
- swelling or pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cambia (Diclofenac Potassium for Oral Solution)
Cambia Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
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 was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with CAMBIA 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. The most common adverse reactions (i.e., that occurred in 1% or more of CAMBIA-treated patients) and more frequent with CAMBIA than with placebo were nausea and dizziness (see Table 1).
Table 1: Adverse Reactions With Incidence > 1% and
Greater Than Placebo in Studies 1 and 2 Combined
| Adverse Reactions | CAMBIA N=634 |
Placebo N=646 |
| Gastrointestinal | ||
| Nausea | 3% | 2% |
| Nervous System | ||
| Dizziness | 1% | 0.5% |
The most common adverse events resulting in discontinuation of patients following CAMBIA dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%). No withdrawals were due to a serious reaction.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of diclofenac or other NSAIDs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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 impairmentt
Read the entire FDA prescribing information for Cambia (Diclofenac Potassium for Oral Solution)
&Copy; Cambia Patient Information is supplied by Cerner Multum, Inc. and Cambia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.