Dolobid Side Effects
Generic name: diflunisal
Medically reviewed by Drugs.com. Last updated on Aug 13, 2024.
Note: This document provides detailed information about Dolobid Side Effects associated with diflunisal. Some dosage forms listed on this page may not apply specifically to the brand name Dolobid.
Applies to diflunisal: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Cardiovascular Thrombotic Events. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.
This risk may occur early in treatment and may increase with duration of use.
Diflunisal tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery Gastrointestinal RiskNSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
These events can occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious gastrointestinal events.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time.
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (eg, steroids or a blood thinner).
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine can cause a rare but serious condition called Reye's syndrome. It occurs mostly in children and teenagers, but can affect someone at any age. Do not give this medicine to anyone who has chicken pox or symptoms of a virus or the flu, unless your doctor has told you to. If a child has behavior changes along with nausea and vomiting while using this medicine, .
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs, severe stomach pain, black, tarry stools, vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different NSAID before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Dolobid
Along with its needed effects, diflunisal (the active ingredient contained in Dolobid) 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 diflunisal:
More common side effects
- stomach cramps or pain
Less common side effects
- back or leg pains
- bleeding gums
- blistering, peeling, loosening of skin
- bloody or black, tarry stools
- bloody or cloudy urine
- blurred or loss of vision
- burning feeling in chest or stomach
- burning while urinating
- clay-colored stools
- constipation
- cough or hoarseness
- cracks in the skin
- dark-colored urine
- diarrhea
- difficult or painful urination
- difficulty breathing
- difficulty swallowing
- disturbed color perception
- dizziness
- double vision
- facial swelling
- fast heartbeat
- feeling of warmth
- fever with or without chills
- flu-like symptoms
- general body swelling
- greatly decreased frequency of urination or amount of urine
- halos around lights
- headache
- hives, itching, skin rash
- increased blood pressure
- increased thirst
- indigestion
- joint or muscle pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- light-colored stools
- loss of appetite
- loss of heat from the body
- lower back or side pain
- muscle aches, pains, or weakness
- nausea or vomiting
- night blindness
- noisy breathing
- nosebleeds
- overbright appearance of lights
- pale skin
- pinpoint red spots on skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- red, irritated eyes
- redness of the face, neck, arms and occasionally, upper chest
- red skin lesions, often with a purple center
- red, swollen skin
- scaly skin
- severe or continuing stomach pain
- sores, ulcers, or white spots in mouth or on lips
- sore throat
- stomach upset, tenderness
- swelling of the face, fingers, feet or lower legs
- swollen lymph nodes
- tightness in chest
- trouble breathing
- tunnel vision
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right stomach pain
- vomiting of blood or material that looks like coffee grounds
- weight gain
- yellow eyes or skin
Symptoms of overdose
- change in consciousness
- confusion about identity, place, and time
- continuing ringing or buzzing or other unexplained noise in ears
- decreased awareness or responsiveness
- deep or fast breathing with dizziness
- fast, pounding, or irregular heartbeat or pulse
- hearing loss
- loss of consciousness
- numbness of feet, hands, and around mouth
- severe sleepiness
- sweating
Other side effects of Dolobid
Some side effects of diflunisal 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 side effects
- acid or sour stomach
- belching
- heartburn
- indigestion
- stomach discomfort or upset
Less common side effects
- bloated, full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- discouragement
- dry mucous membranes
- excess air or gas in stomach or intestines
- feeling of constant movement of self or surroundings
- feeling sad or empty
- increased sensitivity of skin to sunlight
- irritability
- lack or loss of strength
- lightheadedness
- loss of interest or pleasure
- mood or mental changes
- nervousness
- passing gas
- seeing, hearing, or feeling things that are not there
- sensation of spinning
- severe sunburn
- sleeplessness
- swelling or inflammation of the mouth
- tiredness
- trouble concentrating
- trouble sleeping
- unable to sleep
- weight loss
For healthcare professionals
Applies to diflunisal: compounding powder, oral tablet.
General adverse events
The most frequently reported side effects were gastrointestinal in nature and included nausea, vomiting, dyspepsia, gastrointestinal pain, diarrhea, constipation, and flatulence.[Ref]
Gastrointestinal
- Common (1% to 10%): Gastrointestinal (GI) pain, dyspepsia, diarrhea, nausea, vomiting, constipation, flatulence
- Frequency not reported: Peptic ulcer, GI perforation, GI bleeding, gastritis, hematemesis, melena, ulcerative stomatitis, colitis exacerbated, Crohn's disease exacerbated, eructation, GI perforation[Ref]
Cardiovascular
- Frequency not reported: Palpitation, hypertension, cardiac failure, flushing, myocardial infarction[Ref]
Nervous system
- Common (1% to 10%): Headache, dizziness, somnolence
- Frequency not reported: Lightheadedness, paresthesia, syncope, stroke
Dermatologic
- Common (1% to 10%): Rash
- Frequency not reported: Pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, angioedema, sweating, dry mucous membranes, stomatitis, photosensitivity[Ref]
Hematologic
- Frequency not reported: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia
Hepatic
- Frequency not reported: Jaundice, cholestasis, liver function abnormal, hepatitis
Renal
- Frequency not reported: Renal impairment, renal failure, interstitial nephritis, nephritic syndrome
Hypersensitivity
- Frequency not reported: Hypersensitivity vasculitis, hypersensitivity syndrome[Ref]
Other
- Common (1% to 10%): Tinnitus, fatigue
- Frequency not reported: Vertigo, asthenia, edema, chest pain, fulminant necrotizing fasciitis, hearing loss[Ref]
Metabolic
- Frequency not reported: Anorexia[Ref]
Psychiatric
- Common (1% to 10%): Insomnia
- Frequency not reported: Nervousness, depression, hallucination, confusion, disorientation[Ref]
Musculoskeletal
- Frequency not reported: Muscle cramp[Ref]
Ocular
- Frequency not reported: Blurred vision, transient visual disturbance[Ref]
Respiratory
- Frequency not reported: Bronchospasm, dyspnea
Genitourinary
- Frequency not reported: Dysuria, hematuria, proteinuria[Ref]
Immunologic
- Frequency not reported: Acute anaphylaxis[Ref]
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References
1. (2001) "Product Information. Dolobid (diflunisal)." Merck & Co., Inc
2. MHRA. Medicines and Health Regulatory Agency (2013) MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate
More about Dolobid (diflunisal)
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Further information
Dolobid side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.