Cambia
Migraine Triggers May Not Always Trigger Migraines »
"Jan. 23, 2013 -- Worrying about what may trigger a migraine attack adds to the discomfort of many people with migraines. But according to a new study from Denmark, much of that worry may be unfounded.
The researchers studied the effect of l"...
Read the Migraine Triggers May Not Always Trigger Migraines article »
Cambia
Cambia Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cambia in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using diclofenac and call your doctor at once if you have a serious side effect such as:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain, urinating less than usual or not at all;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- bruising, severe tingling, numbness, pain, muscle weakness;
- neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas;
- dizziness, headache, nervousness;
- skin itching or rash;
- blurred vision; or
- ringing in your ears.
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Cambia Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, diarrhea, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), persistent/severe headache, sudden/unexplained weight gain, swelling of the hands/feet, unusual tiredness, vision changes (such as blurred vision).
Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, change in the amount of urine.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cambia (Diclofenac Potassium for Oral Solution)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cambia FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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.
Read the entire FDA prescribing information for Cambia (Diclofenac Potassium for Oral Solution) »
Additional Cambia Information
Cambia - User Reviews
Cambia User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Cambia sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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