美沙拉秦(Salofalk)的副作用和不良反应

In addition to its desired effects, mesalazine (Salofalk) may cause some adverse reactions. Although not all of these side effects will occur, if they do occur, they may require medical attention.

Mesalazine (Salofalk) side effects that require immediate medical attention

1. Common side effects

Bloody diarrhea, rectal bleeding, and stomach pain.

2. Rare side effects

Blood stool, hematuria, blurred vision, chest tightness, chills, clay-colored stools, cough, dark urine, diarrhea, difficulty breathing, dizziness, fever, feeling of fullness or bloating, general malaise or feeling of illness, headache, itchy skin, rash, joint pain, loss of appetite, muscle aches, nausea, and nervousness.

Pain or tenderness around the eyes and cheek bones, ringing in the ears, pressure in the stomach, runny or stuffy nose, tremors, slow or fast heartbeat, sore throat, stomach cramps, sweating, swollen stomach, trouble sleeping, bad breath, unusual tiredness or weakness, vomiting, vomiting blood, yellowing of the eyes or skin.

3. Rare side effects

Anxiety, back pain, blue or pale skin, chest pain (may radiate to the left arm, neck or shoulder).

Other side effects of mesalazine (Salofalk)

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medication. In addition, medical professionals may be able to tell patients how to prevent or reduce certain side effects.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Consult your doctor immediately about side effects of Mesalazine (Salofalk)

1. Common side effects

Sneezing.

2. Less common side effects

Acne, hiccups, persistent tinnitus or other unexplained noises, difficulty moving, dizziness or lightheadedness, excess gas in the stomach or intestines, a sensation of consciousness or surroundings constantly moving, hair loss or thinning hair, hearing loss, heartburn, muscle stiffness, flatulence, dizziness, stomach upset or discomfort.

Side effects management for medical professionals

1. General adverse events

The most common adverse events are headache, belching and exacerbation of ulcerative colitis.

2. Gastrointestinal system

(1), very common (10% or more): belching (up to 16%), exacerbation of ulcerative colitis (up to 15%).

(2), common (1% to 10%): abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal bleeding, rectal disturbance, abnormal stool (change in color or texture), frequent urination, indigestion, vomiting, abdominal bloating, rectal distension, pain during insertion (enema dosage form), hemorrhoids, rectal pain, colitis, constipation, abdominal distention.

(3), Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonatal diarrhea, anal discomfort, bowel urgency, ulcerative colitis (ulcerative proctitis), glossitis, rectal polyps, pancreatitis, application site irritation (rectal foam dosage form), painful tenesmus, rectal urgency.

(4), rare (less than 0.1%): elevated amylase.

(5), frequency not reported: duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, gastrointestinal bleeding, oral ulcer, oral candidiasis, rectal bleeding, rectal polyps, mild dyspepsia and colic, bloody diarrhea, stomatitis, abdominal enlargement, elevated lipase.

(6) Post-marketing reports: frequent defecation, mucus, painful defecation, rectal pain, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, and elevated amylase.

3. Nervous system

(1), very common (10% or more): headache (up to 24%).

(2). Common (1% to 10%): dizziness.

(3) Uncommon (0.1% to 1%): paresthesias, peripheral neuropathy, drowsiness, and tremor.

(4). Very rare (less than 0.01%): dizziness.

(5). Frequency not reported: neuropathy, mild disorientation.

(6) Post-marketing reports: Guillain-Barré syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, and tinnitus.

4. Others

(1), very common (10% or more): pain (up to 14%).

(2) Common (1% to 10%): fatigue, fatigue, fever, infection.

(3) Uncommon (0.1% to 1%): earache, peripheral edema.

(4), rare (less than 0.1%): drug fever.

(5). Frequency not reported: malaise, mesalazine acute intolerance syndrome, ear congestion, adenovirus infection, pain, loss of body mass index.

(6) Post-marketing reports: drug residues, increased alkaline phosphatase, increased GGT, increased LDH, and ear fullness.

5. Respiratory system

(1), very common (10% or more): nasopharyngitis (up to 15%).

(2). Common (1% to 10%): upper respiratory tract infection, flu-like symptoms, rhinitis, cold/sore throat.

(3), Uncommon (0.1% to 1%): allergic and fibrotic pulmonary reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, pulmonary infiltrates, pneumonia, sore throat.

(4). Very rare (less than 0.01%): eosinophilic pneumonia.

(5). Frequency not reported: hypersensitivity pneumonitis (including interstitial pneumonia, allergic alveolitis, eosinophilic pneumonia), headache, interstitial pulmonary fibrosis, bronchiolitis obliterans, and sinusitis.

(6). Post-marketing reports: fibrosing alveolitis, asthma exacerbation, pleurisy, bronchitis.

6. Cardiovascular system

(1), common (1% to 10%): hypertension, vasodilation.

(2) Uncommon (0.1% to 1%): pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension.

(3). Frequency not reported: chest pain, T wave abnormalities, Kawasaki disease-like syndrome.

7. Dermatology

(1), common (1% to 10%): rash, alopecia, urticaria, itching, acne.

(2) Uncommon (0.1% to 1%): lupus-like syndrome, allergic rash, hyperhidrosis, angioedema, Stevens-Johnson syndrome, facial edema.

(3), very rare (less than 0.01%): reversible alopecia, bullous skin reaction (including erythema multiforme).

(4). Frequency not reported: dry skin, eczema, erythema nodosum, nail disease, photosensitivity, lichen planus, ecchymosis.

(5) Post-marketing reports: prurigo, erythema, psoriasis, and pyoderma gangrenosum.

8. Musculoskeletal system

(1), common (1% to 10%): back pain, joint pain, leg/joint pain.

(2) Uncommon (0.1% to 1%): myalgia, chills, myositis, arthritis.

(3), frequency not reported: leg cramps, lower back discomfort, muscle spasms, neck pain.

(4). Post-marketing report: joint disorders, rheumatoid arthritis.

9. Liver

(1), common (1% to 10%): Abnormal liver function, elevated alanine aminotransferase.

(2) Uncommon (0.1% to 1%): hepatitis, elevated liver enzymes (transaminase activity), intrahepatic cholestasis, elevated bilirubin.

(3). Very rare (less than 0.01%): liver toxicity (including cirrhosis, liver failure), changes in liver function parameters.

(4), frequency not reported: elevated GGTP, elevated SGOT, elevated SGPT, sclerosing cholangitis, elevated alkaline phosphatase.

(5). Post-marketing reports: jaundice, cholestatic jaundice, hepatic necrosis, and cholecystitis.

10. Metabolic system

(1). Common (1% to 10%): anorexia.

(2). Frequency not reported: thirst, edema.

(3). Post-marketing reports: increased appetite and gout.

11. Eyes

(1). Common (1% to 10%): abnormal vision.

(2) Uncommon (0.1% to 1%): conjunctivitis.

(3). Post-marketing report: blurred vision and eye pain.

12. Kidney

(1), Uncommon (0.1% to 1%): acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity.

(2). Very rare (less than 0.01%): nephrotic syndrome, urine discoloration.

(3). Frequency not reported: Decreased creatinine clearance.

(4) Post-marketing reports: minimal change nephropathy, increased serum creatinine and BUN.

13. Blood system

(1), Uncommon (0.1% to 1%): thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, decreased platelet count.

(2), very rare (less than 0.01%): eosinophilia (as part of allergic reaction), anemia, bone marrow suppression.

(3). Frequency not reported: thrombocythemia.

(4). Post-marketing reports: granulocytopenia and lymphadenopathy.

14. Hypersensitivity reaction

(1), uncommon (0.1% to 1%): anaphylaxis, anaphylaxis, drug reaction with eosinophilia and systemic symptoms (DRESS).

(2). Frequency not reported: anaphylactic shock, angioedema.

15. Genitourinary system

(1), Uncommon (0.1% to 1%): Oligozoospermia (reversible), urinary tract infection/burning sensation during urination.

(2). Frequency not reported: proteinuria, amenorrhea, breast pain, hematuria, oligomenorrhea, menorrhagia, irregular uterine bleeding, frequent urination.

(3) Post-marketing reports: dysuria, urgency, and epididymitis.

16. Mental system

(1) Uncommon (0.1% to 1%): insomnia.

(2). Frequency not reported: depression, anxiety, loss of libido.

(3). Post-marketing report: nervousness, confusion, emotional instability, and confusion.