What are the possible side effects of Galtaren?
Get emergency medical help if you have signs of an allergic reaction to Galtaren: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
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 Galtaren and call your doctor at once if you have:
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the first sign of any skin rash, no matter how mild;
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shortness of breath (even with mild exertion);
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swelling or rapid weight gain;
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
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high blood pressure - severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;
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low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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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.
Common Galtaren side effects may include:
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indigestion, gas, stomach pain, nausea, vomiting;
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diarrhea, constipation;
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headache, dizziness, drowsiness;
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stuffy nose;
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itching, increased sweating;
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increased blood pressure; or
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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.
Side effects of Galtaren in details
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Hepatotoxicity
- Hypertension
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic Reactions
- Serious Skin Reactions
- Hematologic Toxicity
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 Galtaren was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with Galtaren for a single migraine headache. Following treatment with Galtaren potassium (either Galtaren or Galtaren 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 Galtaren-treated patients) and more frequent with Galtaren than with placebo were nausea and dizziness.
Table 1: Adverse Reactions With Incidence > 1% and Greater Than Placebo in Studies 1 and 2 Combined
| Adverse Reactions | Galtaren 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 Galtaren 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 Galtaren 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 Galtaren And Other NSAIDs
In patients taking Galtaren 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
What is the most important information I should know about Galtaren?
- Galtaren patch may cause dizziness or drowsiness. Theses effects may be worse if you take it with alcohol or certain medicines. Use Galtaren patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Galtaren patch is for use on the skin only. Do not get it in your eyes, nose, or mouth. If you get Galtaren patch in your eye, wash the eye out with water or saline right away. Contact your doctor if irritation persists for more than 1 hour.
- Do NOT use more than 1 patch at a time or use Galtaren patch for longer than prescribed without checking with your doctor.
- If irritation occurs at the application site, remove the patch and contact your doctor.
- Serious stomach ulcers or bleeding can occur with the use of Galtaren patch. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Galtaren patch with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Galtaren patch is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Galtaren patch unless your doctor tells you to.
- Lab tests, including kidney and liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Galtaren patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Galtaren patch with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
- Galtaren patch should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Galtaren patch may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Galtaren patch while you are pregnant. It is not known if Galtaren patch is found in breast milk. Do not breast-feed while using Galtaren patch.
Galtaren contraindications
Hypersensitivity to Galtaren sodium or to any of the excipients of Galtaren.
Active gastric or intestinal ulcer, bleeding or perforation.
Last trimester of pregnancy.
Hepatic, renal and severe cardiac failure.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid and/or other drugs with prostaglandin-synthetase inhibitory activity.
Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.
The use of high dose Galtaren (150 mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.
Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: The use of high dose Galtaren (150mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If Galtaren treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (eg, hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for >4 weeks. As the cardiovascular risks of Galtaren may increase with dose and duration of exposure, Galtaren should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Galtaren is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Galtaren to patients with mild to moderate renal impairment.
Hepatic Impairment: Galtaren is contraindicated in patients with hepatic failure. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Galtaren to patients with mild to moderate hepatic impairment.
References
- DailyMed. "DICLOFENAC EPOLAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Diclofenac: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "DICLOFENAC". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Galtaren are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Galtaren. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
