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Dolobid

Last reviewed on RxList: 4/25/2017
Dolobid Side Effects Center

Last reviewed on RxList 02/08/2017

Dolobid (diflunisal) Tablets is a nonsteroidal anti-inflammatory drug (NSAID) indicated for acute or long-term use for symptomatic treatment of mild to moderate pain, osteoarthritis, and rheumatoid arthritis. Dolobid is available in generic form. Side effects of Dolobid include:

  • nausea,
  • stomach pain,
  • vomiting,
  • upset stomach,
  • diarrhea,
  • constipation,
  • gas,
  • dizziness,
  • drowsiness,
  • headache,
  • tired feeling,
  • sleep problems (insomnia), or
  • ringing in your ears.

Tell your doctor if you have serious side effects of Dolobid including:

  • bleeding from the stomach (can be fatal),
  • chest pain,
  • stroke,
  • shortness of breath,
  • stomach pain,
  • swelling of the hands or feet,
  • sudden or unexplained weight gain,
  • vision changes,
  • hearing changes (e.g., ringing in the ears),
  • mental/mood changes (e.g., confusion, hallucinations),
  • fast or pounding heartbeat,
  • persistent or severe headache,
  • fainting,
  • difficult or painful swallowing.

Dolobid is available in 250 and 500 mg strength tablets. For mild to moderate pain, an initial dose of 1000 mg followed by 500mg every 12 hours is recommended for most patients. Following the initial dose,some patients may require 500 mg every 8 hours. For osteoarthritis and rheumatoid arthritis, the suggested dosage range is 500mg to 1000 mg daily in two divided doses. Tablets should be swallowed whole, not crushed or chewed. Dolobid may interact with antacids, antidepressants, acetaminophen (Tylenol), blood thinners, cyclosporine, diuretics (water pills), lithium, methotrexate, or heart or blood pressure medications. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Dolobid. Taking Dolobid during the last 3 months of pregnancy may result in birth defects. Do not take Dolobid during pregnancy unless your doctor has told you to. Dolobid can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Dolobid (diflunisal) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Dolobid Consumer Information

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 taking diflunisal and call your doctor at once if you have any of these serious side effects:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • fever, chills, body aches, flu symptoms;
  • pale or yellowed skin, dark colored urine, confusion;
  • 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);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, stomach pain, vomiting, upset stomach;
  • diarrhea, constipation, gas;
  • dizziness, drowsiness, headache, tired feeling;
  • sleep problems (insomnia); 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 Dolobid (Diflunisal)

Dolobid Professional Information

SIDE EFFECTS

The adverse reactions observed in controlled clinical trials encompass observations in 2,427 patients.

Listed below are the adverse reactions reported in the 1,314 of these patients who received treatment in studies of two weeks or longer. Five hundred thirteen patients were treated for at least 24 weeks, 255 patients were treated for at least 48 weeks, and 46 patients were treated for 96 weeks. In general, the adverse reactions listed below were 2 to 14 times less frequent in the 1,113 patients who received short-term treatment for mild to moderate pain.

Incidence Greater Than 1%

Gastrointestinal

The most frequent types of adverse reactions occurring with DOLOBID (diflunisal) are gastrointestinal: these include nausea** , vomiting, dyspepsia**, gastrointestinal pain**, diarrhea**, constipation, and flatulence.

Psychiatric

  Somnolence, insomnia.

Central Nervous System

  Dizziness.  

Special Senses

  Tinnitus.

Dermatologic

  Rash**.

Miscellaneous

  Headache**, fatigue/tiredness.

Incidence Less Than 1 in 100

The following adverse reactions, occurring less frequently than 1 in 100, were reported in clinical trials or since the drug was marketed. The probability exists of a causal relationship between DOLOBID (diflunisal) and these adverse reactions.

Dermatologic

Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity.

Gastrointestinal

Peptic ulcer, gastrointestinal bleeding, anorexia, eructation, gastrointestinal perforation, gastritis.
Liver function abnormalities; jaundice, sometimes with fever; cholestasis; hepatitis.

Hematologic

Thrombocytopenia; agranulocytosis; hemolytic anemia.

Genitourinary

Dysuria; renal impairment, including renal failure; interstitial nephritis; hematuria; proteinuria.

Psychiatric

Nervousness, depression, hallucinations, confusion, disorientation.

Central Nervous System

Vertigo; light-headedness; paresthesias.

Special Senses

Transient visual disturbances including blurred vision.

Hypersensitivity Reactions

Acute anaphylactic reaction with bronchospasm; angioedema; flushing.

Hypersensitivity vasculitis.

Hypersensitivity syndrome (see WARNINGS, Hypersensitivity Syndrome).

Miscellaneous

Asthenia, edema.

Causal Relationship Unknown

Other reactions have been reported in clinical trials or since the drug was marketed, but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

Respiratory

  Dyspnea.

Cardiovascular

  Palpitation, syncope.

Musculoskeletal

  Muscle cramps.

Genitourinary

  Nephrotic syndrome.

Special Senses

 Hearing loss.

Miscellaneous

  Chest pain.

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A α-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including diflunisal, sometimes with fatal outcome (see also PRECAUTIONS, General).

Potential Adverse Effects

In addition, a variety of adverse effects not observed with DOLOBID (diflunisal) in clinical trials or in marketing experience, but reported with other non-steroidal analgesic/anti-inflammatory agents, should be considered potential adverse effects of DOLOBID (diflunisal) .

**Incidence between 3% and 9%. Those reactions occurring in 1% to 3% are not marked with an asterisk.

Read the entire FDA prescribing information for Dolobid (Diflunisal)

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