Saleto-600 Side Effects

Generic name: ibuprofen

Medically reviewed by Drugs.com. Last updated on Jul 31, 2024.

Note: This document provides detailed information about Saleto-600 Side Effects associated with ibuprofen. Some dosage forms listed on this page may not apply specifically to the brand name Saleto-600.

Applies to ibuprofen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable.

Other dosage forms:

• intravenous solution

Important warnings This medicine can cause some serious health issues

Oral route (tablet; suspension; capsule, liquid filled; tablet, chewable)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease.

Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Serious side effects of Saleto-600

Along with its needed effects, ibuprofen (the active ingredient contained in Saleto-600) 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 ibuprofen:

More common

• abdominal pain
• acid or sour stomach
• belching
• bloating
• cloudy urine
• decrease in amount of urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• full feeling
• heartburn
• indigestion
• itching skin
• pain or discomfort in chest, upper stomach, or throat
• pale skin
• passing gas
• nausea
• noisy, rattling breathing
• rash with flat lesions or small raised lesions on the skin
• shortness of breath
• swelling of face, fingers, hands, feet, lower legs, or ankles
• troubled breathing at rest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain

Less common

• abdominal cramps
• stomach soreness or discomfort

Rare

• agitation
• back, leg, or stomach pains
• bleeding gums
• blistering, peeling, loosening of skin
• blood in urine or stools
• bloody, black, or tarry stools
• blurred vision
• burning feeling in chest or stomach
• change in vision
• chest pain
• chills
• clay-colored stools
• coma
• confusion
• constipation
• cough or hoarseness
• dark urine
• decreased urine output
• depression
• difficulty breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• dry mouth
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• fever with or without chills
• frequent urination
• general body swelling
• general feeling of tiredness or weakness
• hair loss, thinning of hair
• headache
• hives or welts
• hostility
• impaired vision
• increased blood pressure
• increased volume of pale, dilute urine
• irregular breathing
• irritability
• itching
• joint or muscle pain
• lab results that show problems with liver
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle twitching
• nosebleeds
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of skin
• seizures
• severe abdominal pain, cramping, burning
• severe and continuing nausea
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stiff neck or back
• stomach upset
• stupor
• swollen or painful glands
• tenderness in stomach area
• thirst
• tightness in chest
• unpleasant breath odor
• upper right abdominal pain
• vomiting of blood
• vomiting of material that looks like coffee grounds
• wheezing
• yellow eyes and skin

Symptoms of overdose

• bluish lips or skin
• difficulty sleeping
• disorientation
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness to profound coma
• hallucination
• lightheadedness or fainting
• mood or other mental changes
• muscle tremors
• not breathing
• rapid, deep breathing
• restlessness
• slow or irregular heartbeat
• stomach cramps
• sudden fainting
• sweating

Other side effects of Saleto-600

Some side effects of ibuprofen 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

• continuing ringing or buzzing or other unexplained noise in ears
• hearing loss
• nervousness

Rare

• crying
• depersonalization
• discouragement
• dry eyes
• dysphoria
• euphoria
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• mental depression
• paranoia
• quick to react or overreact
• rapidly changing moods
• runny nose
• sleepiness or unusual drowsiness
• sleeplessness
• sneezing
• stuffy nose
• trouble concentrating
• trouble sleeping
• unable to sleep

For healthcare professionals

Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet chewable.

General

The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea, vomiting, flatulence, and diarrhea.

Patent Ductus Arteriosus: The most frequently reported adverse effects were sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up to 10%)
• Common (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress, indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena
• Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis
• Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis, exacerbation of Crohn's disease
• Frequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding, glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitis

Patent Ductus Arteriosus:

• Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)
• Common (1% to 10%): Necrotizing enterocolitis, intestinal perforation
• Frequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia
• Postmarketing reports: GI perforation^[Ref]

Cardiovascular

• Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%)
• Very rare (less than 0.01%): Cardiac failure
• Frequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations, vasculitis, sinus bradycardia, angina pectoris, thrombotic events

Patent Ductus Arteriosus:

• Frequency not reported: Tachycardia, cardiac failure, hypotension^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 12%)
• Common (1% to 10%): Dizziness, nervousness
• Very rare (less than 0.01%): Cerebrovascular accident
• Frequency not reported: Syncope, drowsiness, paresthesia, somnolence, tremors, convulsions, coma

Patent Ductus Arteriosus:

• Common (1% to 10%): Intraventricular hemorrhage, periventricular hemorrhage
• Frequency not reported: Convulsions^[Ref]

Renal

• Very rare (less than 0.01%): Acute renal failure, renal papillary necrosis, interstitial nephritis, nephrotic syndrome, renal failure, renal insufficiency
• Frequency not reported: Cystitis, azotemia, creatinine clearance decreased, glomerulitis, tubular necrosis, nephrotoxicity

Patent Ductus Arteriosus:

• Very common (10% or more): Renal events (21%)
• Uncommon (0.1% to 1%): Acute renal failure^[Ref]

The number of total renal events in preterm infants within 30 days of therapy following IV use was 21% and included increased blood urea (7%), renal insufficiency/impairment (6%), reduced urine output (3%), increased blood creatinine (3%), renal failure (1%), and increased blood urea with hematuria (1%).^[Ref]

Hematologic

• Very common (10% or more): Anemia (up to 36%), eosinophilia (up to 26%), neutropenia (up to 13%), thrombocythemia (up to 10%)
• Common (1% to 10%): Hemoglobin decreased
• Very rare (less than 0.01%): Leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, hematocrit decreased
• Frequency not reported: lymphadenopathy, bleeding episodes

Patent Ductus Arteriosus:

• Very common (10% or more): Anemia (32%), total bleeding (32%), intraventricular hemorrhage (29%), Neutropenia, thrombocytopenia^[Ref]

The incidence of total bleeding events within 30 days of therapy with IV use in preterm infants was 32%. This percentage included grade 1 and 2 intraventricular hemorrhage (15%), grade 3 and 4 intraventricular hemorrhage (15%), and other bleeding (6%).^[Ref]

Dermatologic

• Common (1% to 10%): Rash, maculopapular rash, pruritus
• Very rare (less than 0.01%): Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis
• Frequency not reported: Ecchymosis, purpura, alopecia, sweating, photosensitivity, angioedema, exfoliative dermatitis, urticaria, vesiculobullous eruptions, Henoch Schonlein vasculitis

Patent Ductus Arteriosus:

• Very common (10% or more): Skin lesion/irritation (16%)^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (up to 19%), hypoproteinemia (up to 13%), blood urea increased (10%), hypernatremia (10%), hypoalbuminemia (10%)
• Common (1% to 10%): Appetite decreased, fluid retention
• Frequency not reported: Appetite changes, hyperglycemia, hypoglycemic reaction, acidosis

Patent Ductus Arteriosus:

• Very common (10% or more): Hypoglycemia (12%), hypocalcemia (12%), blood creatinine increased, blood sodium decreased
• Common (1% to 10%): Hypernatremia
• Frequency not reported: Feeding problems, hyperglycemia^[Ref]

Other

• Very common (10% or more): Bacteremia (13%), blood LDH increased (up to 10%)
• Common (1% to 10%): Peripheral edema, wound hemorrhage, tinnitus, hearing impairment, edema, fatigue
• Very rare (less than 0.01%): Aseptic meningitis, vertigo, exacerbation of infection-related inflammations
• Frequency not reported: Fever, infection, sepsis, weight changes, asthenia, malaise, pseudo-tumor, hearing loss, drowsiness

Patent Ductus Arteriosus:

• Very common (10% or more): Sepsis (43%)
• Common (1% to 10%): Edema, fluid retention
• Frequency not reported: Various infections^[Ref]

Respiratory

• Very common (10% or more): Bacterial pneumonia (up to 10%)
• Common (1% to 10%): Cough
• Very rare (less than 0.01%): Asthma, bronchospasm, dyspnea, wheezing
• Frequency not reported: Apnea, respiratory depression, pneumonia, rhinitis, epistaxis

Patent Ductus Arteriosus:

• Very common (10% or more): Apnea (28%), respiratory infection (19%), respiratory failure (10%), bronchopulmonary dysplasia
• Common (1% to 10%): Atelectasis, pulmonary hemorrhage
• Uncommon (0.1% to 1%): Hypoxemia
• Postmarketing reports: Pulmonary hypertension^[Ref]

Hepatic

• Very rare (less than 0.01%): Hepatitis, jaundice
• Frequency not reported: Hepatorenal syndrome, liver necrosis, liver failure, abnormal liver function tests

Patent Ductus Arteriosus:

• Frequency not reported: Cholestasis, jaundice^[Ref]

Hypersensitivity

• Frequency not reported: Anaphylactoid reactions, hypersensitivity reaction^[Ref]

Hypersensitivity reactions have been reported and may consist of any of the following: a syndrome of abdominal pain, fever, chills, nausea, vomiting, and anaphylaxis; respiratory tract reactivity comprising bronchospasm, asthma/aggravated asthma, or dyspnea; skin reactions, which rarely included exfoliative and bullous dermatoses, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, pruritus, and urticaria.^[Ref]

Ocular

• Very rare (less than 0.01%): Visual disturbances
• Frequency not reported: Blurred vision, amblyopia, diminished vision, scotomata, changes in color vision, conjunctivitis, dry eyes, diplopia, optic neuritis, cataracts, optic neuritis, toxic optic neuropathy^[Ref]

Musculoskeletal

• Frequency not reported: Lupus erythematosus syndrome^[Ref]

Psychiatric

• Frequency not reported: Anxiety, confusion, depression, dream abnormalities, insomnia, emotional lability, hallucinations^[Ref]

Genitourinary

• Common (1% to 10%): Urinary retention
• Very rare (less than 0.01%): Proteinuria, hematuria
• Frequency not reported: Dysuria, oliguria, polyuria, menorrhagia

Patent Ductus Arteriosus:

• Very common (10% or more): Oliguria, hematuria
• Common (1% to 10%): Urinary tract infection^[Ref]

Immunologic

• Frequency not reported: Serum sickness^[Ref]

Local

• Common (1% to 10%): Infusion site pain
• Postmarketing reports: Transient sensation of burning in mouth/throat

Patent Ductus Arteriosus:

• Frequency not reported: Injection site reactions^[Ref]

Endocrine

• Frequency not reported: Gynecomastia

Patent Ductus Arteriosus:

• Common (1% to 10%): Adrenal insufficiency^[Ref]

Frequently asked questions

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Further information

Saleto-600 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer