Zipsor Side Effects Center

Last updated on RxList: 10/25/2021
Zipsor Side Effects Center

What Is Zipsor?

Zipsor (diclofenac potassium) Liquid Filled Capsules is a nonsteroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain.

What Are Side Effects of Zipsor?

Common side effects of Zipsor include:

  • abdominal pain,
  • constipation,
  • diarrhea,
  • indigestion,
  • nausea,
  • vomiting,
  • dizziness,
  • headache,
  • drowsiness,
  • itching, and
  • increased sweating

Dosage for Zipsor

The dosage of Zipsor is 25 mg four times a day.

What Drugs, Substances, or Supplements Interact with Zipsor?

Zipsor may interact with aspirin and anticoagulants. Tell your doctor all medications and supplements you use.

Zipsor During Pregnancy or Breastfeeding

Zipsor is not recommended for use during pregnancy; it may harm a fetus. Starting at 30 weeks gestation, Zipsor should be avoided. It is unknown if Zipsor passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Zipsor (diclofenac potassium) Liquid Filled Capsules 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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Zipsor 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.

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Zipsor Professional Information

SIDE EFFECTS

The following 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 clinical trials of a drug cannot be directly compared with the rates in clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ZIPSOR was evaluated in 965 adult subjects. In patients treated with ZIPSOR 25 mg (N=345) or a higher dose, three or four times a day, for 4 to 5 days, the most common adverse reactions (i.e., reported in ≥ 1% of ZIPSOR treated patients) were as follows: gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increased sweating. (see Table 1).

The safety of ZIPSOR was evaluated in 125 pediatric patients, 12 years to 17 years of age. Forty-nine (49) patients with mild to moderate acute pain from a surgical procedure or an acute painful condition were treated with ZIPSOR 25 mg up to four times a day, for 4 days. Seventy-six (76) pediatric patients who underwent insertion of either orthodontic separators or arch wires were treated with a single-dose of either ZIPSOR 25 mg or ZIPSOR 50 mg after completion of the procedure. The most common adverse reactions in the multiple-dose studies were nausea (14.3%), headache (10.2%), constipation (8.2%), abdominal pain (4.1%), vomiting (4.1%), dizziness (4.1%), back pain (4.1%), and musculoskeletal pain (4.1%).

Table 1 Incidence of Treatment Emergent Adverse Reactions with Incidence ≥ 1% of ZIPSOR Treated Patients in Multiple-Dose Studies

MedDRA System Organ Class and Preferred Term ZIPSOR*
25 mg
n=345
n (%)
Placebo*
n=327
n (%)
Any Adverse Events 144 (41.7) 181 (55.4)
Nausea 57 (16.5) 66 (20.2)
Headache 43 (12.5) 56 (17.1)
Abdominal Pain 24 (7.0) 11 (3.4)
Vomiting 20 (5.8) 17 (5.2)
Dizziness 12 (3.5) 66 (20.2)
Constipation 11 (3.2) 9 (2.8)
Somnolence 9 (2.6) 6 (1.8)
Diarrhea 8 (2.3) 9 (2.8)
Pruritus 5 (1.4) 6 (1.8)
Dyspepsia 4 (1.2) 8 (2.4)
Sweating Increase 4 (1.2) 2 (0.6)
*There was greater use of concomitant opioid rescue medication in placebo treated patients than in ZIPSOR treated patients

In patients taking other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:

Gastrointestinal experiences 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 experiences reported in patients taking other NSAIDs occasionally include:

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 other 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

DRUG INTERACTIONS

See Table 3 for clinically significant drug interactions with diclofenac.

Table 3: Clinically Significant Drug Interactions with diclofenac

Drugs That Interfere with Hemostasis
Clinical Impact:
  • Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
  • Serotonin release by platelets plays an important role in hemostasis. Case-controland cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptakeand an NSAID may potentiate the risk of bleedingmore than an NSAID alone.
Intervention: Monitor pa tients with concomitant use of ZIPSOR with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., a spirin), selective serotonin reuptakeinhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Aspirin
Clinical Impact: Controlled clinical studies showed that theconcomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention: Concomitantuse of ZIPSOR andanalgesic doses of aspirin is not generally recommended because of the increased risk of bleeding[see WARNINGS AND PRECAUTIONS].

ZIPSOR is not a substitutefor low dose a spirin for cardiovascular protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of rena l function, including possible acute renal failure. These effects are usually reversible.
Intervention:
  • During concomitantuse of ZIPSOR a nd ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure thatthe desired blood pressure is obtained.
  • During concomitantuse of ZIPSOR andACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or haveimpaired renal function, monitor for signs of worsen in grenal function [see WARNINGS AND PRECAUTIONS].
  • When these drugs a re a dministered concomitantly, patients should be adequately hydrated. Assess renal function at thebeginningof the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the na triuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prosta gla ndin synthesis.
Intervention: During concomitant useof ZIPSOR with diuretics, observe patients for signs of worsening rena l function, in a ddition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentrationand prolong the half-life of digoxin.
Intervention: During concomitantuse of ZIPSOR and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact: NSAIDs have produced elevations in pla sma lithium levels and reductions in renal lithium clearance.The mean minimum lithium concentration increased 15%, andthe renal clearancedecreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of ZIPSOR and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact: Concomitantuse of NSAIDs and methotrexatemay increase therisk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renaldysfunction).
Intervention: During concomitantuse of ZIPSOR and methotrexate, monitor patients for methotrexatetoxicity.
Cyclosporine
Clinical Impact: Concomitantuse of ZIPSOR and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention: During concomitant useof ZIPSOR and cyclosporine, monitor patients for signs of worsening rena l function.
NSAIDs and Salicylates
Clinical Impact: Concomitantuse of diclofenac with other NSAIDs or salicylates (e.g., diflunisa l, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention: The concomitant use of diclofenac with other NSAIDs or sa licylates is not recommended.
Pemetrexed
Clinical Impact: Concomitantuse of ZIPSOR and pemetrexed may increase the risk of pemetrexedassociated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitantuse of ZIPSOR andpemetrexed, in pa tients with renal impairment whose creatinine clearanceranges from 45 to 79 mL/min, monitor for myelosuppression, rena l and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absenceof data regarding potentialinteraction between pemetrexed a nd NSAIDs with longer half-lives (e.g., meloxica m, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two da ys followingpemetrexed administration.

CYP2C9 Inhibitors or Inducers:
Clinical Impact: Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac.
Intervention: A dosage adjustment may be warranted when diclofenac is administered with CYP2C9 inhibitors or inducers [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Zipsor (Diclofenac Potassium Liquid Filled Capsules)

© Zipsor Patient Information is supplied by Cerner Multum, Inc. and Zipsor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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