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Synalgos-DC Side Effects

Generic Name: aspirin / caffeine / dihydrocodeine

Note: This document contains side effect information about aspirin / caffeine / dihydrocodeine. Some of the dosage forms listed on this page may not apply to the brand name Synalgos-DC.

For the Consumer

Applies to aspirin / caffeine / dihydrocodeine: oral capsule

Along with its needed effects, aspirin / caffeine / dihydrocodeine 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 aspirin / caffeine / dihydrocodeine:

More common
  • Lightheadedness

Get emergency help immediately if any of the following symptoms of overdose occur while taking aspirin / caffeine / dihydrocodeine:

Symptoms of overdose
  • Confusion
  • difficult or troubled breathing
  • extreme sleepiness
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin

Some side effects of aspirin / caffeine / dihydrocodeine 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
  • Difficulty having a bowel movement (stool)
  • dizziness
  • drowsiness
  • itching skin
  • nausea
  • relaxed and calm
  • sleepiness
  • vomiting

For Healthcare Professionals

Applies to aspirin / caffeine / dihydrocodeine: oral capsule

General

The most frequently expected adverse reactions based on the individual components include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus and skin reactions.[Ref]

Gastrointestinal

Dihydrocodeine:
Frequency not reported: Nausea, vomiting, constipation, abdominal pain, diarrhea, dry mouth, indigestion, spasm of biliary tract

Caffeine:
Frequency not reported: Diarrhea, nausea, stomach pain, vomiting[Ref]

Hypersensitivity

Dihydrocodeine:
Frequency not reported: Anaphylactoid reactions, hypersensitivity reactions[Ref]

Respiratory

Dihydrocodeine:
Frequency not reported: Respiratory depression, cough suppression[Ref]

Psychiatric

Dihydrocodeine:
Frequency not reported: Confusion, physical and psychological dependence, hallucinations vivid dreams

Caffeine:
Frequency not reported: Anxiety, anxiety neurosis, excitement, insomnia, irritability, restlessness, tenseness[Ref]

Dermatologic

Dihydrocodeine:
Frequency not reported: Sweating, pruritus, skin reactions

Caffeine:
Frequency not reported: Urticaria[Ref]

Cardiovascular

Dihydrocodeine:
Frequency not reported: Orthostatic hypotension

Caffeine:
Frequency not reported: Extrasystoles, palpitations, tachycardia[Ref]

Endocrine

Opioids:
Frequency not reported: Adrenal insufficiency, androgen deficiency[Ref]

Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis and lead to androgen deficiency; however, the causal role of opioids is unknown due to the lack of studies into the many medical, physical, lifestyle, and psychological stressors that influence gonadal hormone levels.[Ref]

Genitourinary

Dihydrocodeine:
Frequency not reported: Urinary retention[Ref]

Metabolic

Dihydrocodeine:
Frequency not reported: Anorexia[Ref]

Nervous system

Dihydrocodeine:
Rare (less than 0.1%): Narcosis
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, headache

Caffeine:
Frequency not reported: Headaches, lightheadedness, tremor

Opioids:
Frequency not reported: Serotonin syndrome[Ref]

Ocular

Dihydrocodeine:
Frequency not reported: Miosis

Caffeine:
Frequency not reported: Scintillating scotoma[Ref]

Other

Dihydrocodeine:
Frequency not reported: Fatigue

Caffeine:
Frequency not reported: Tinnitus[Ref]

Renal

Dihydrocodeine:
Rare (less than 0.1%): Acute renal failure
Frequency not reported: Granulomatous interstitial nephritis

Caffeine:
Frequency not reported: Diuresis[Ref]

References

1. "Product Information. Synalgos-DC (aspirin / caffeine / dihydrocodeine (ASA/caffeine/dihydrocodeine))." Sun Pharmaceutical Industries, Cranbury, NJ.

2. "Product Information. Trezix (acetaminophen/caffeine/dihydrocodeine)." WraSer Pharmaceuticals, Madison, MS.

3. US Food and Drug Administration "Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications. Available from: URL: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm491715.htm." ([2016, Mar 22]):

Some side effects of Synalgos-DC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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