The side effects associated with hydrazine sulfate use have been mainly gastrointestinal and neurologic.[1-12] Nausea and/or vomiting, dizziness, and sensory and motor neuropathies have been reported.[1-12] The sensory and motor neuropathies have included paresthesias (abnormal touch sensations, such as burning or prickling, in the absence of external stimuli) of the upper and lower extremities (i.e., the arms and the legs, including the hands and the feet), polyneuritis (simultaneous inflammation of several peripheral nerves), and impaired fine motor function (e.g., an impaired ability to write).[2,5,7-9] Other side effects have included dry skin and/or itching, insomnia, and hypoglycemia.[1,2,7,9] One case of fatal liver and kidney failure and one case of severe encephalopathy (an injury to the brain) have been associated with the use of hydrazine sulfate.[13,14] The former case involved a man aged 55 years with squamous cell carcinoma of the maximillary sinus who purchased hydrazine sulfate from a source found on the Internet and proceeded to take it without medical advice or supervision. After 4 months he presented with evidence of renal and liver toxicity, which eventually resulted in death. This case highlights the danger of accessing materials and medical information on the Internet and proceeding with self- medication without seeking proper medical advice and supervision.[15]

The side effects of hydrazine sulfate have been described as mild to moderate in severity, and their incidence appears to have been low. Most side effects are reported to resolve when treatment is stopped. However, limited evidence from animal studies suggests that hydrazine sulfate is highly toxic when combined with either alcohol or barbiturates.[16-18] Reviewed in [19]

References

1. Spremulli E, Wampler GL, Regelson W: Clinical study of hydrazine sulfate in advanced cancer patients. Cancer Chemother Pharmacol 3 (2): 121-4, 1979.  [PUBMED Abstract]
   
   
2. Gold J: Use of hydrazine sulfate in terminal and preterminal cancer patients: results of investigational new drug (IND) study in 84 evaluable patients. Oncology 32 (1): 1-10, 1975.  [PUBMED Abstract]
   
   
3. Kosty MP, Fleishman SB, Herndon JE 2nd, et al.: Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B. J Clin Oncol 12 (6): 1113-20, 1994.  [PUBMED Abstract]
   
   
4. Loprinzi CL, Goldberg RM, Su JQ, et al.: Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer. J Clin Oncol 12 (6): 1126-9, 1994.  [PUBMED Abstract]
   
   
5. Filov VA, Gershanovich ML, Danova LA, et al.: Experience of the treatment with Sehydrin (Hydrazine Sulfate, HS) in the advanced cancer patients. Invest New Drugs 13 (1): 89-97, 1995.  [PUBMED Abstract]
   
   
6. Lerner HJ, Regelson W: Clinical trial of hydrazine sulfate in solid tumors. Cancer Treat Rep 60 (7): 959-60, 1976.  [PUBMED Abstract]
   
   
7. Gershanovich ML, Danova LA, Kondratyev VB, et al.: Clinical data on the antitumor activity of hydrazine sulfate. Cancer Treat Rep 60 (7): 933-5, 1976.  [PUBMED Abstract]
   
   
8. Gershanovich ML, Danova LA, Ivin BA, et al.: Results of clinical study antitumor action of hydrazine sulfate. Nutr Cancer 3 (1): 7-12, 1981.  [PUBMED Abstract]
   
   
9. Ochoa M Jr, Wittes RE, Krakoff IH: Trial of hydrazine sulfate (NSC-150014) in patients with cancer. Cancer Chemother Rep 59 (6): 1151-4, 1975 Nov-Dec.  [PUBMED Abstract]
   
   
10. Chlebowski RT, Bulcavage L, Grosvenor M, et al.: Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. Cancer 59 (3): 406-10, 1987.  [PUBMED Abstract]
    
    
11. Chlebowski RT, Heber D, Richardson B, et al.: Influence of hydrazine sulfate on abnormal carbohydrate metabolism in cancer patients with weight loss. Cancer Res 44 (2): 857-61, 1984.  [PUBMED Abstract]
    
    
12. Herndon JE 2nd, Fleishman S, Kosty MP, et al.: A longitudinal study of quality of life in advanced non-small cell lung cancer: Cancer and Leukemia Group B (CALGB) 8931. Control Clin Trials 18 (4): 286-300, 1997.  [PUBMED Abstract]
    
    
13. Hainer MI, Tsai N, Komura ST, et al.: Fatal hepatorenal failure associated with hydrazine sulfate. Ann Intern Med 133 (11): 877-80, 2000.  [PUBMED Abstract]
    
    
14. Nagappan R, Riddell T: Pyridoxine therapy in a patient with severe hydrazine sulfate toxicity. Crit Care Med 28 (6): 2116-8, 2000.  [PUBMED Abstract]
    
    
15. Black M, Hussain H: Hydrazine, cancer, the Internet, isoniazid, and the liver. Ann Intern Med 133 (11): 911-3, 2000.  [PUBMED Abstract]
    
    
16. Masaki H, Arai H, Torii K: Newly developed animal model with alcoholic liver damage induced by an inhibitor for gluconeogenesis, hydrazine sulfate. Gastroenterol Jpn 24 (5): 584, 1989.  [PUBMED Abstract]
    
    
17. Suzuki H, Tominaga T, Mizuno H, et al.: Ethanol and hydrazine sulfate induced chronic hepatic injury in rats: the curative effect of administration of glucogenic amino acids. Alcohol Alcohol Suppl 1A: 111-7, 1993.  [PUBMED Abstract]
    
    
18. Gold J: Incompatibility of hydrazine sulfate and pentobarbital in the treatment of tumor bearing animals. [Abstract] Proc Am Assoc Cancer Res 18: A-999, 250, 1977. 
    
    
19. U.S. General Accounting Office.: Cancer Drug Research: Contrary to Allegation, NIH Hydrazine Sulfate Studies Were Not Flawed. Washington, DC: U.S. General Accounting Office, 1995, GAO-HEHS-95-141. Also available online. ¹ Last accessed May 19, 2008. 
    
    

Glossary Terms

A drug used to treat insomnia, seizures, and convulsions, and to relieve anxiety and tension before surgery. It belongs to the family of drugs called central nervous system (CNS) depressants.

A disorder of the brain that can be caused by disease, injury, drugs, or chemicals.

Refers to the stomach and intestines. Also called GI.

A substance that has been studied as a treatment for cancer and as a treatment for cachexia (body wasting) associated with advanced cancer.

Abnormally low blood sugar.

Redness, swelling, pain, and/or a feeling of heat in an area of the body. This is a protective reaction to injury, disease, or irritation of the tissues.

Difficulty in going to sleep or getting enough sleep.

A condition in which the kidneys stop working and are not able to remove waste and extra water from the blood or keep body chemicals in balance. Acute or severe kidney failure happens suddenly (for example, after an injury) and may be treated and cured. Chronic kidney failure develops over many years, may be caused by conditions like high blood pressure or diabetes, and cannot be cured. Chronic kidney failure may lead to total and long-lasting kidney failure, called end-stage renal disease (ESRD). A person in ESRD needs dialysis (the process of cleaning the blood by passing it through a membrane or filter) or a kidney transplant. Also called renal failure.

A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.

A legal drug that is used to prevent, treat, or relieve symptoms of a disease or abnormal condition.

A feeling of sickness or discomfort in the stomach that may come with an urge to vomit. Nausea is a side effect of some types of cancer therapy.

Having to do with nerves or the nervous system.

A nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Neuropathy may be caused by physical injury, infection, toxic substances, disease (such as cancer, diabetes, kidney failure, or malnutrition), or drugs, including anticancer drugs. Also called peripheral neuropathy.

An abnormal touch sensation, such as burning or prickling, that occurs without an outside stimulus.

Inflammation of several peripheral nerves at the same time.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Cancer that begins in squamous cells, which are thin, flat cells that look like fish scales. Squamous cells are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the passages of the respiratory and digestive tracts. Also called epidermoid carcinoma.

Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects.

The extent to which something is poisonous or harmful.

To eject some or all of the contents of the stomach through the mouth.