Omenex Side effects

• Side effects of Omenex in details
• Omenex contraindications
• Omenex reviews

What are the possible side effects of Omenex?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Omenex + SyrSpend SF Alka and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• new or unusual pain in your wrist, thigh, hip, or back;

• seizure (convulsions);

• kidney problems--little or no urination, blood in your urine, swelling, rapid weight gain;

• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking Omenex + SyrSpend SF Alka long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use Omenex + SyrSpend SF Alka for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• stomach pain, gas;

• nausea, vomiting, diarrhea; or

• headache.

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.

See also:

Side effects (in more detail)

Side effects of Omenex in details

Clinical Trials Experience With Omenex Monotherapy

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflects exposure to Omenex Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from Omenex-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).

Additional adverse reactions that were reported with an incidence ≥ 1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).

The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

The clinical trial safety profile in pediatric patients who received Omenex Delayed-Release Capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in both the 1 to < 2 and 2 to 16 year age groups (75.0% and 18.5%, respectively). Similarly, fever was frequently reported in the 1 to 2 year age group (33.0%), and accidental injuries were reported frequently in the 2 to 16 year age group (3.8%).

Clinical Trials Experience With Omenex In Combination Therapy For H. pylori Eradication

In clinical trials using either dual therapy with Omenex and clarithromycin, or triple therapy with Omenex, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with Omenex, clarithromycin, or amoxicillin alone.

Dual Therapy (Omenex/clarithromycin)

Adverse reactions observed in controlled clinical trials using combination therapy with Omenex and clarithromycin (n = 346) that differed from those previously described for Omenex alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section.)

Triple Therapy (Omenex/clarithromycin/amoxicillin)

The most frequent adverse reactions observed in clinical trials using combination therapy with Omenex, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections.)

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Omenex Delayed-Release Capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria,; fever; pain; fatigue; malaise;

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: Gynecomastia

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis. During treatment with Omenex, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued.

Gastroduodenal carcinoids have been reported in patients with ZE syndrome on long-term treatment with Omenex. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]

Infections and Infestations: Clostridium difficile associated diarrhea

Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain

Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture

Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory: Epistaxis, pharyngeal pain

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Special Senses: Tinnitus, taste perversion

Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leucocytosis

What is the most important information I should know about Omenex?

• Omenex delayed-release capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Omenex delayed-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.
• Do NOT change your dose, stop taking Omenex delayed-release capsules, or take Omenex delayed-release capsules for longer than prescribed without checking with your doctor.
• Omenex delayed-release capsules may increase the risk of a serious form of diarrhea. Contact your doctor right away if stomach pain or cramps, severe or persistent diarrhea, or bloody or watery stools occur. Discuss any questions or concerns with your doctor.
• Omenex delayed-release capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Omenex delayed-release capsules in high doses, for longer than a year, or if you are older than 50 years old. Contact your doctor if you have any questions about this information.
• Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Omenex delayed-release capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).
• Long-term treatment (eg, longer than 3 years) with medicines like this one has rarely caused low vitamin B12 levels. Discuss any questions or concerns with your doctor.
• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you take Omenex delayed-release capsules.
• Omenex delayed-release capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Omenex delayed-release capsules.
• Omenex delayed-release capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients.
• Use Omenex delayed-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Omenex delayed-release capsules while you are pregnant. Omenex delayed-release capsules is found in breast milk. Do not breast-feed while taking Omenex delayed-release capsules.

Omenex contraindications

You should not take this medication if you are allergic to Omenex or to any other benzimidazole medication such as albendazole or mebendazole. Omenex is not for immediate relief of heartburn symptoms.

Ask a doctor or pharmacist if it is safe for you to take Omenex if you have liver disease or heart disease, or low levels of magnesium in your blood.

Some conditions are treated with a combination of Omenex and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Omenex OTC (over-the-counter) should be taken for no longer than 14 days in a row. Allow at least 4 months to pass before you start another 14-day treatment.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

References

1. DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "omeprazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(S)- sodium 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology